A Study to Evaluate the Effectiveness and Safety of MEDI-528 in Adults
Study Details
Study Description
Brief Summary
To study the effectiveness and safety of multiple-doses of MEDI-528 on asthma control in adult participants with uncontrolled, moderate-to-severe, persistent asthma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The primary objective of this study is to evaluate the effect of multiple-dose subcutaneous (SC) administration of MEDI-528 on asthma control in adults with uncontrolled, moderate-to-severe, persistent asthma.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MEDI528 30 mg MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
Biological: MEDI528 30 mg
MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
|
| Experimental: MEDI528 100 mg MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
Biological: MEDI528 100 mg
MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
|
| Experimental: MEDI528 300 mg MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
Biological: MEDI528 300 mg
MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
|
| Experimental: Placebo Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks |
Other: Placebo
Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
|
Outcome Measures
Primary Outcome Measures
- Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) [Day 92]
Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Secondary Outcome Measures
- Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis) [Days 1 - 92]
Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
- Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis) [Days 1 - 176]
Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
- Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) [Days 1 - 92]
The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
- Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) [Days 1 - 176]
The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
- Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) [Days 1 - 92]
Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
- Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) [Days 1 - 176]
Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy.
- Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis) [Day 176]
Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
- Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) [Day 92]
Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
- Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) [Day 176]
Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
- Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis) [Days 1 - 92]
Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
- Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis) [Days 1 - 176]
Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
- Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) [Day 92]
Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1.
- Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) [Day 176]
Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176
- Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis) [Day 85]
Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.
- Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis) [Day 176]
Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences.
- Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528 [Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323]
Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo
- First Dose Trough Concentration of MEDI-528 [Day 15]
First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose.
- Day 169 Steady State Trough Concentration of MEDI-528 [Day 169]
Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169.
- Half Life of MEDI-528 [Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323]
Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.
- Accumulation Ratio of Trough Concentrations of MEDI-528 [Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323]
Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323.
Eligibility Criteria
Criteria
Inclusion Criteria
Subjects must meet all of the following criteria:
-
Male or female
-
Age 18 through 65 years at the time of screening
-
Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
-
Female subjects of childbearing potential who are sexually active with non-sterilized male partner must use adequate contraception from screening through the end of the study. An acceptable method of contraception is defined as one that has no higher than a 1% failure rate. Sustained abstinence is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception
-
Non-sterilized males who are sexually active with a female of child-bearing potential must use adequate contraception from screening through the end of the study
-
Females or female partners not of childbearing potential must have been surgically sterilized (eg, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or postmenopausal (defined as at least 1 year since last regular menses)
-
Sterilized males must be at least 1-year post vasectomy and have obtained documentation of the absence of sperm in the ejaculate
-
Weight ≥ 45 kg but ≤ 120 kg and body mass index (BMI) between 18 and 35 kg/m2
-
Physician-diagnosed asthma by medical chart
-
Currently taking inhaled corticosteroids (ICS) or is a candidate to receive ICS per Expert Panel Report (EPR)-3
-
Pre-bronchodilator forced expiratory volume in 1 second (FEV1) value ≥ 40% at Day -28 and Day 1
-
A post-bronchodilator increase in FEV1 and/or FVC ≥ 12% and ≥ 200 mL at Day -28 OR meeting any one of the following criteria:
-
Proof of post-bronchodilator reversibility of airflow obstruction ≥ 12% documented within 36 months prior to randomization or proof of a positive response to a methacholine challenge documented within 36 months prior to randomization; OR
-
Proof of partial reversibility of ≥ 8% to < 12% improvement in post-bronchodilator FEV1 on Day -28 and achievement of ≥ 12% reversibility at a second time between Day -27 and Day -15; OR
-
If a) and b) are not met and all other inclusion/exclusion criteria are met, subjects with a FEV1 of ≥ 1.5 L and ≥ 60% on Day -14 will be eligible to undergo a methacholine challenge. If the subject achieves a positive response to this methacholine challenge, then this criterion is met
-
Uncontrolled asthma consistent with EPR-3. In the 28 days before screening, subjects should have a history of one or more of the following:
-
Daytime asthma symptoms ≥ 2 days/week
-
Nighttime awakening ≥ 1 night/week
-
Albuterol/salbutamol use ≥ 2 days/week
-
An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at Day -28 and at Day 1.
-
At least one asthma exacerbation in the 12 months before screening that required intake of systemic corticosteroids after an unscheduled medical encounter or as agreed with a physician based on an asthma action plan that defines when oral steroids can be taken by the subject
-
Ability and willingness to complete the follow-up period through Day 323 as required by the protocol.
Exclusion Criteria
Any of the following would exclude the subject from participation in the study:
-
Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
-
Concurrent enrollment in another clinical study
-
Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
-
Known history of allergy or reaction to any component of the investigational product formulation
-
History of anaphylaxis to other biologic therapy
-
Lung disease other than asthma (eg, chronic obstructive pulmonary disease [COPD], cystic fibrosis)
-
Severe depression as measured by a depression score > 15 on the Hospital Anxiety and Depression Scale (HADS) at either Day-28 or Day 1.
-
History of suicidal behavior in the previous 3 years as measured by the Columbia Suicide Severity Rating Scale (C-SSRS) at Day -28.
-
Acute illness other than asthma at the screening and randomization visits
-
History of an active infection within 28 days before and during the screening period, or evidence of clinically significant active infection, including ongoing chronic infection
-
History of ingestion of untreated water in a location known to be infected with parasites, resulting in acute or chronic diarrhea; history of recent travel to areas where parasite infestations are endemic within 6 months before screening; or a diagnosis of parasitic infection within 6 months before screening
-
Use of immunosuppressive medication (except oral prednisone up to a dose of 20 mg every other day or equivalent [eg, 10 mg a day or 5 mg twice a day] and inhaled and topical corticosteroids) within 28 days before randomization
-
Receipt of immunoglobulin or blood products within 28 days before randomization
-
Plans to donate blood during the entire study period
-
Donated blood or has had a blood transfusion within 28 days before screening
-
Receipt of any non-biological study drugs or interventional therapy (including surgical procedures) within 28 days of the first dose of investigational product in this study
-
Receipt of any biologicals including MEDI-528 within 5 half-lives before the first dose of investigational product in this study
-
History of any known immunodeficiency disorder
-
A positive hepatitis B surface antigen, or hepatitis C virus antibody, as determined by medical history and/or subject's verbal report
-
A positive human immunodeficiency virus test or is taking antiretroviral medications, as determined by medical history and/or subject's verbal report
-
A live attenuated vaccination received within 28 days before screening
-
History of clinically significant abnormality on electrocardiogram (ECG) in the opinion of the investigator
-
Breastfeeding or lactating
-
History of treatment for alcohol or drug abuse within the past year
-
History suggestive of COPD or of tobacco smoking ≥ 10 pack-years
-
Evidence of any uncontrolled systemic disease upon physical examination
-
History of cancer, apart from basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy ≥ 1 year before Day 1 or other malignancies treated with apparent success with curative therapy ≥ 5 years before screening
-
Any noninfectious disease involving multiple organs (eg, cystic fibrosis, systemic lupus erythematosus, hemophilia, multiple sclerosis, etc.) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
-
Individuals who are legally institutionalized
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Pell City | Alabama | United States | 35128 |
| 2 | Research Site | Los Angeles | California | United States | 90025 |
| 3 | Research Site | Sacramento | California | United States | 95819 |
| 4 | Research Site | San Diego | California | United States | 92123 |
| 5 | Research Site | Centennial | Colorado | United States | 80112 |
| 6 | Research Site | Colarado Springs | Colorado | United States | 80907 |
| 7 | Research Site | Thornton | Colorado | United States | 80233 |
| 8 | Research Site | Waterbury | Connecticut | United States | 06708 |
| 9 | Research Site | Kissimmee | Florida | United States | 34741 |
| 10 | Research Site | Normal | Illinois | United States | 61761 |
| 11 | Research Site | Overland Park | Kansas | United States | 66210 |
| 12 | Research Site | Louisville | Kentucky | United States | 40215 |
| 13 | Research Site | Baltimore | Maryland | United States | 21236 |
| 14 | Research Site | Silver Spring | Maryland | United States | 20902 |
| 15 | Research Site | N. Dartmouth | Massachusetts | United States | 02747 |
| 16 | Research Site | Minneapolis | Minnesota | United States | 55402 |
| 17 | Research Site | Omaha | Nebraska | United States | 68131 |
| 18 | Research Site | Mt. Laurel | New Jersey | United States | 08054 |
| 19 | Research Site | Sylvania | Ohio | United States | 43560 |
| 20 | Research Site | Medford | Oregon | United States | 97504 |
| 21 | Research Site | Lincoln | Rhode Island | United States | 02865 |
| 22 | Research Site | Greenville | South Carolina | United States | 29607 |
| 23 | Research Site | El Paso | Texas | United States | 79903 |
| 24 | Research Site | San Antonio | Texas | United States | 78229 |
| 25 | Research Site | Buenos Aire | Caba | Argentina | 1425 |
| 26 | Research Site | Ciudad Autonoma Bs As | Ciudad de Buenos Aires | Argentina | 1405 |
| 27 | Research Site | Rosario | Santa Fe | Argentina | 2000 |
| 28 | Research Site | San Miguel de Tucuman | Tucuman | Argentina | T4000IAR |
| 29 | Research Site | Buenos Aires | Argentina | C1424BSF | |
| 30 | Research Site | Ciudad de Buenos Aire | Argentina | 1425 | |
| 31 | Research Site | Porto Alegre | RS | Brazil | 90020-090 |
| 32 | Research Site | Porto Alegre | RS | Brazil | 90610-000 |
| 33 | Research Site | Florianopolis | Santa Catarina | Brazil | 88040-970 |
| 34 | Research Site | Santo André | Brazil | 09060-870 | |
| 35 | Research Site | Sao Paulo | Brazil | 05403-000 | |
| 36 | Research Site | Calgary | Alberta | Canada | T2N 4Z6 |
| 37 | Research Site | Edmonton | Alberta | Canada | T6G 2B7 |
| 38 | Research Site | Vancouver | British Columbia | Canada | V5Z 1M9 |
| 39 | Research Site | Mississauga | Ontario | Canada | L5A 3V4 |
| 40 | Research Site | Ottawa | Ontario | Canada | K1Y 4G2 |
| 41 | Research Site | Montreal | Quebec | Canada | H2X 2P4 |
| 42 | Research Site | Quebec City | Quebec | Canada | G1V 4M6 |
| 43 | Research Site | Quebec | Canada | ||
| 44 | Research Site | Bogota DC | Cundinamarca | Colombia | |
| 45 | Research Site | Bogota | Cundinamarca | Colombia | |
| 46 | Research Site | Bogotá D.C. | Cundinamarca | Colombia | |
| 47 | Research Site | San Francisco de Dos Rios | San José | Costa Rica | |
| 48 | Research Site | Ciudad de Panama | Panama | ||
| 49 | Research Site | Jesus Maria | Lima | Peru | Lima 11 |
| 50 | Research Site | Lima | Peru | Lima 27 | |
| 51 | Research Site | Lima | Peru | LIMA 33 | |
| 52 | Research Site | Lima | Peru | ||
| 53 | Research Site | Lipa City | Batangas | Philippines | |
| 54 | Research Site | Iloilo City | Iloilo | Philippines | 5000 |
| 55 | Research Site | Quezon City | Metro Manila | Philippines | 870 |
| 56 | Research Site | Kaohsiung | Taiwan | ||
| 57 | Research Site | Taoyuan | Taiwan |
Sponsors and Collaborators
- MedImmune LLC
Investigators
- Study Director: Chad Oh, M.D., MedImmune LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MI-CP198
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 329 participants was randomized into the study, but 2 participants (1 in the MEDI-528 30 mg arm and 1 in the MEDI-528 300 mg arm) were randomized by mistake as they were screen failures. Therefore, a total of 327 participants were correctly randomized into the study. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Period Title: Overall Study | ||||
| STARTED | 82 | 81 | 83 | 81 |
| COMPLETED | 64 | 63 | 72 | 72 |
| NOT COMPLETED | 18 | 18 | 11 | 9 |
Baseline Characteristics
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | Total of all reporting groups |
| Overall Participants | 82 | 81 | 83 | 81 | 327 |
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
43.6
(11.6)
|
41.8
(11.1)
|
45.1
(11.6)
|
41.5
(12.3)
|
43.0
(11.7)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
53
64.6%
|
55
67.9%
|
62
74.7%
|
55
67.9%
|
225
68.8%
|
| Male |
29
35.4%
|
26
32.1%
|
21
25.3%
|
26
32.1%
|
102
31.2%
|
Outcome Measures
| Title | Change at Day 92 From Baseline in Mean Asthma Control Questionnaire (ACQ) Scores (Intent-toTreat Analysis) |
|---|---|
| Description | Change at Day 92 from baseline (Day 1, prior to dosing) in mean ACQ scores in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. |
| Time Frame | Day 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Mean (Standard Deviation) [Scores on a scale] |
-1.23
(0.95)
|
-1.10
(1.11)
|
-1.26
(1.02)
|
-1.31
(1.07)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.435 |
| Comments | ||
| Method | ANOVA | |
| Comments | Missing mean ACQ scores at Day 92 was imputed by last observation carried forward | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.828 |
| Comments | ||
| Method | ANOVA | |
| Comments | Missing mean ACQ scores at Day 92 was imputed by last observation carried forward | |
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.628 |
| Comments | ||
| Method | ANOVA | |
| Comments | Missing mean ACQ scores at Day 92 was imputed by last observation carried forward | |
| Title | Weighted Asthma Exacerbation Rate Through Day 92 (Intent-to-Treat Analysis) |
|---|---|
| Description | Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
| Time Frame | Days 1 - 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Number (95% Confidence Interval) [Exacerbations per participant year] |
0.53
(0.96)
|
0.82
(1.15)
|
0.33
|
0.39
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.271 |
| Comments | ||
| Method | Pairwise Poisson Regression | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.319 |
| Comments | ||
| Method | Pairwise Poisson Regression | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.502 |
| Comments | ||
| Method | Pairwise Poisson Regression | |
| Comments | ||
| Title | Weighted Asthma Exacerbation Rate Through Day 176 (Intent-to-Treat Analysis) |
|---|---|
| Description | Weighted asthma exacerbation rate (total number of exacerbation rate in each group per total duration of participant-year follow-up in each group) between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
| Time Frame | Days 1 - 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Number (95% Confidence Interval) [Exacerbations per participant year] |
0.58
(0.96)
|
0.64
(1.15)
|
0.28
|
0.58
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.756 |
| Comments | ||
| Method | Pairwise Poisson Regression | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.047 |
| Comments | ||
| Method | Pairwise Poisson Regression | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.000 |
| Comments | ||
| Method | Pairwise Poisson Regression | |
| Comments | ||
| Title | Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) |
|---|---|
| Description | The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
| Time Frame | Days 1 - 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Number [Participants] |
8
(0.15)
9.8%
|
14
(0.14)
17.3%
|
5
6%
|
7
8.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.1764 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.4031 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Proportion of Participants Experiencing at Least One Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) |
|---|---|
| Description | The proportion of participants that experienced at least one asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
| Time Frame | Days 1 - 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Number [Participants] |
16
(0.15)
19.5%
|
17
(0.14)
21%
|
8
9.6%
|
15
18.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8475 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0811 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.0000 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Time to First Asthma Exacerbation Through Day 92 (Intent-to-Treat Analysis) |
|---|---|
| Description | Time to first asthma exacerbation between Day 1 and Day 92 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
| Time Frame | Days 1 - 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Median (95% Confidence Interval) [Day] |
NA
(2.10)
|
NA
(3.38)
|
NA
(2.14)
|
NA
(2.27)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.144 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.938 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.395 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.618 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.863 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.899 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to First Asthma Exacerbation Through Day 176 (Intent-to-Treat Analysis) |
|---|---|
| Description | Time to first asthma exacerbation between Day 1 and Day 176 in pariticpants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). An exacerbation was defined as a progressive increase of asthma symptoms AND a reduction of 20% or more in peak expiratory flow (PEF) or forced expiratory volume in 1 second (FEV1) from baseline (Day 1, prior to dosing) or best previously measured value prior to the current event that did not resolve after the initiation of rescue medications; and results in a prescription for/or administration of systemic corticosteroid burst therapy by the investigator or health care provider. An exacerbation event was considered resolved when the subject's asthma symptoms diminished and PEF or FEV1 return to greater than 80% of baseline for 7 or more days after completion of systemic corticosteroid burst therapy. |
| Time Frame | Days 1 - 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized and received at least one dose of investigational product (30, 100, or 300 mg MEDI-528 or placebo) |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Median (95% Confidence Interval) [Day] |
NA
(5.30)
|
NA
(7.15)
|
NA
(4.70)
|
NA
(5.40)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.717 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 1.162 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.070 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.467 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.934 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.955 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change at Day 176 From Baseline in Mean Asthma Control Questionnaire Scores (Intent-to-Treat Analysis) |
|---|---|
| Description | Change at Day 176 from baseline (Day 1, prior to dosing) in mean ACQ scores in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. |
| Time Frame | Day 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Mean (Standard Deviation) [Scores on a scale] |
-1.27
(1.17)
|
-1.32
(1.23)
|
-1.46
(1.07)
|
-1.45
(1.08)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.813 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.290 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.303 |
| Comments | ||
| Method | ANOVA | |
| Comments | ||
| Title | Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 92 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) |
|---|---|
| Description | Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 92 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. |
| Time Frame | Day 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 92. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| < or = 0.75 |
17
20.7%
|
17
21%
|
17
20.5%
|
22
27.2%
|
| > 0.75 and < 1.5 |
23
28%
|
21
25.9%
|
22
26.5%
|
16
19.8%
|
| > or = 1.5 |
42
51.2%
|
43
53.1%
|
44
53%
|
43
53.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg |
|---|---|---|
| Comments | Combined MEDI-528 treatment was compared to placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.764 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Proportion of Participants Achieving Mean Asthma Control Questionnaire (ACQ) Scores at Day 176 of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 (Intent-to-Treat Analysis) |
|---|---|
| Description | Proportion of participants achieving mean ACQ scores of < or = 0.75, > 0.75 to < 1.5, and > or = 1.5 at Day 176 in participants receiving 30, 100, or 300 mg MEDI-528 versus placebo (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. |
| Time Frame | Day 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data available on Day 176. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| < or = 0.75 |
25
30.5%
|
29
35.8%
|
24
28.9%
|
25
30.9%
|
| > 0.75 and < 1.5 |
19
23.2%
|
18
22.2%
|
18
21.7%
|
20
24.7%
|
| > or = 1.5 |
38
46.3%
|
34
42%
|
41
49.4%
|
36
44.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg |
|---|---|---|
| Comments | Combined MEDI-528 treatment was compared to placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.986 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 92 (Intent-to-Treat Analysis) |
|---|---|
| Description | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 0.5 through Day 92 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. |
| Time Frame | Days 1 - 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 92. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Median (95% Confidence Interval) [Day] |
15.0
(2.62)
|
17.0
(2.93)
|
20.0
(2.67)
|
20.0
(2.89)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7171 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.955 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6219 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.942 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.6182 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.909 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to First Observed Mean Asthma Control Questionnaire (ACQ) Change From Baseline > or = 0.5 Through Day 176 (Intent-to-Treat Analysis) |
|---|---|
| Description | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the time to first observed mean ACQ change from baseline (Day 1, prior to dosing) > or = 1.5 Through Day 176 (Intent-to-Treat Analysis). The 6-item ACQ is a participant-reported questionnaire assessing asthma symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing) and daily rescue bronchodilator use. Participants were asked to recall how their asthma had been during the previous week. Questions were weighted equally and scored from 0 (totally controlled) to 6 (severely uncontrolled). The mean ACQ score is the mean of the responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates uncontrolled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful. |
| Time Frame | Days 1 - 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had ACQ data through Day 176. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Median (95% Confidence Interval) [Day] |
15.0
(4.07)
|
17.0
(4.57)
|
20.0
(3.63)
|
20.0
(4.70)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7120 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.952 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5086 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.928 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.5184 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified by atopic asthma status and steroid use | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.887 | |
| Confidence Interval |
() % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change at Day 92 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) |
|---|---|
| Description | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change at Day 92 from baseline (Day 1, prior to dosing) in FEV1. |
| Time Frame | Day 92 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 92 (n=62, 73, or 72 for 30, 100, or 300 mg MEDI-528, respectively, and n=67 for placebo). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 67 | 62 | 73 | 72 |
| Mean (Standard Deviation) [Liters] |
0.033
(0.326)
|
0.045
(0.327)
|
0.048
(0.230)
|
0.097
(0.290)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.837 |
| Comments | ||
| Method | Two-sample t-test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.756 |
| Comments | ||
| Method | Two-sample t-test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.224 |
| Comments | ||
| Method | Two-sample t-test | |
| Comments | ||
| Title | Change at Day 176 From Baseline in Forced Expiratory Volume in One Second (FEV1) (Intent-to-Treat Analysis) |
|---|---|
| Description | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the mean change from baseline (Day 1, prior to dosing) in FEV1 at Day 176 |
| Time Frame | Day 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the 30, 100, or 300 mg MEDI-528 (n=81, 83, or 81, respectively) or placebo (n=82) groups who had FEV1 data available at Day 176 (n=67, 75, or 73 for 30, 100, or 300 mg MEDI-528, respectively, and n=69 for placebo). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 69 | 67 | 75 | 73 |
| Mean (Standard Deviation) [Liters] |
0.044
(0.367)
|
-0.005
(0.324)
|
0.055
(0.299)
|
0.047
(0.290)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.409 |
| Comments | ||
| Method | Two-sample t-test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 100 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.847 |
| Comments | ||
| Method | Two-sample t-test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 300 mg |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.968 |
| Comments | ||
| Method | Two-sample t-test | |
| Comments | ||
| Title | Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 85 (Intent-to-Treat Analysis) |
|---|---|
| Description | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response (defined as an improvement of at least 0.5 score in AQLQ[S]) at Day 85 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences. |
| Time Frame | Day 85 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 85 (n=69, 63, 76, and 68 for placebo, 30, 100, and 300 mg MEDI-528, respectively). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 69 | 63 | 76 | 68 |
| Number [Participants] |
53
(57.871)
64.6%
|
43
(60.584)
53.1%
|
52
(53.110)
62.7%
|
49
(55.339)
60.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg |
|---|---|---|
| Comments | Combined MEDI-528 dose groups versus placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.208 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Proportion of Participants Who Had a Asthma Quality of Life Questionnaire - Standard (AQLQ[S]) Assessment Response at Day 176 (Intent-to-Treat Analysis) |
|---|---|
| Description | Effect of MEDI-528 (30, 100, or 300 mg) versus placebo on the proportion of participants who had an AQLQ(S) assessment response at Day 176 (Intent-to-Treat Analysis). The AQLQ(S) is a 32-item questionnaire that measures the health related quality of life experienced by asthma patients. In the study, participants were asked to recall their experiences during the previous 2 weeks and to score each of the 32 questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Individual improvement in the overall score of 0.5 has been identified as the minimally important difference, with score changes > 1.5 identified to be large meaningful differences. |
| Time Frame | Day 176 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo group (n=82) who had AQLQ(S) data at Day 176 (n=62, 58, 64, and 60 for placebo, 30, 100, and 300 mg MEDI-528, respectively). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 62 | 58 | 64 | 60 |
| Number [Participants] |
50
(57.871)
61%
|
42
(60.584)
51.9%
|
48
(53.110)
57.8%
|
46
(55.339)
56.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Placebo, MEDI528 30 mg, MEDI528 100 mg, MEDI528 300 mg |
|---|---|---|
| Comments | Combined MEDI-528 dose groups versus placebo | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.574 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Proportion of Participants With Detectable Anti-drug Antibodies to MEDI-528 |
|---|---|
| Description | Proportion of participants with detectable anti-drug antibodies to MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528 and placebo |
| Time Frame | Days 1, 29, 57, 85, 127, 169, 176, 204,260, and 323 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81), or placebo (n=82) group and received at least one dose of investigational product. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 82 | 81 | 83 | 81 |
| Number [Participants] |
4
4.9%
|
15
(1.53)
18.5%
|
4
(1.83)
4.8%
|
3
(1.99)
3.7%
|
| Title | First Dose Trough Concentration of MEDI-528 |
|---|---|
| Description | First dose trough concentration of MEDI-528 measured on Day 15 prior to administration of the second dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. The first dose trough concentration of MEDI-528 was measured on Day 15 prior to the Day 15 dose. |
| Time Frame | Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 0 | 81 | 83 | 81 |
| Mean (Standard Deviation) [Microgram per milliliter] |
2.15
(0.81)
|
5.91
(2.97)
|
15.80
(5.68)
|
| Title | Day 169 Steady State Trough Concentration of MEDI-528 |
|---|---|
| Description | Trough concentration of MEDI-528 measured on Day 169 prior to administration of the last dose of MEDI-528 (30, 100, or 300 mg). Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. Steady state trough concentration of MEDI-528 was measured on Day 169. |
| Time Frame | Day 169 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 0 | 81 | 83 | 81 |
| Mean (Standard Deviation) [Microgram per milliliter] |
5.99
(3.37)
|
21.68
(9.49)
|
61.57
(26.85)
|
| Title | Half Life of MEDI-528 |
|---|---|
| Description | Half life of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. |
| Time Frame | Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants randomized into the 30, 100, or 300 mg MEDI-528 group (n=81, 83, or 81, respectively). |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 0 | 81 | 83 | 81 |
| Mean (Standard Deviation) [Days] |
39.0
(8.14)
|
32.6
(5.89)
|
32.2
(6.41)
|
| Title | Accumulation Ratio of Trough Concentrations of MEDI-528 |
|---|---|
| Description | Accumulation ratio of trough concentrations of MEDI-528 in subjects receiving 30, 100, or 300 mg MEDI-528. Serum concentrations of MEDI-528 were measured on Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323. |
| Time Frame | Days 1, 15, 29, 57, 85, 127, 169, 176, 204, 232, 260, 288, and 323 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were randomized into the 30 mg MEDI-528 (n=81), 100 mg MEDI-528 (n=83), 300 mg MEDI-528 (n=81) and received at least one dose of investigational product. |
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg |
|---|---|---|---|---|
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks |
| Measure Participants | 0 | 81 | 83 | 81 |
| Mean (Standard Deviation) [Ratio] |
3.46
(1.53)
|
4.18
(1.83)
|
4.11
(1.99)
|
Adverse Events
| Time Frame | Day 1 to Day 323 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg | ||||
| Arm/Group Description | Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks | ||||
All Cause Mortality |
||||||||
| Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/82 (4.9%) | 9/81 (11.1%) | 4/83 (4.8%) | 2/81 (2.5%) | ||||
| Gastrointestinal disorders | ||||||||
| Pancreatitis | 1/82 (1.2%) | 1 | 0/81 (0%) | 0 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 1/82 (1.2%) | 1 | 0/81 (0%) | 0 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Hydrocholecystis | 1/82 (1.2%) | 1 | 0/81 (0%) | 0 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Immune system disorders | ||||||||
| Food allergy | 0/82 (0%) | 0 | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Infections and infestations | ||||||||
| Appendicitis | 1/82 (1.2%) | 1 | 0/81 (0%) | 0 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Bronchitis | 0/82 (0%) | 0 | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Lobar pneumonia | 0/82 (0%) | 0 | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 | 0/81 (0%) | 0 |
| Pneumonia | 0/82 (0%) | 0 | 3/81 (3.7%) | 3 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||
| Limb traumatic amputation | 0/82 (0%) | 0 | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Thoracic vertebral fracture | 0/82 (0%) | 0 | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 | 0/81 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Muscle spasms | 0/82 (0%) | 0 | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 | 0/81 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Uterine leiomyoma | 0/82 (0%) | 0 | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 | 0/81 (0%) | 0 |
| Nervous system disorders | ||||||||
| Complicated migraine | 0/82 (0%) | 0 | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Ischaemic stroke | 0/82 (0%) | 0 | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Renal and urinary disorders | ||||||||
| Nephrolithiasis | 1/82 (1.2%) | 1 | 0/81 (0%) | 0 | 0/83 (0%) | 0 | 0/81 (0%) | 0 |
| Reproductive system and breast disorders | ||||||||
| Vaginal haemorrhage | 0/82 (0%) | 0 | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 | 0/81 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 0/82 (0%) | 0 | 6/81 (7.4%) | 6 | 1/83 (1.2%) | 1 | 2/81 (2.5%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||||
| Placebo | MEDI528 30 mg | MEDI528 100 mg | MEDI528 300 mg | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 67/82 (81.7%) | 62/81 (76.5%) | 68/83 (81.9%) | 69/81 (85.2%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 2/82 (2.4%) | 2 | 3/81 (3.7%) | 3 | 3/83 (3.6%) | 4 | 3/81 (3.7%) | 3 |
| Toothache | 1/82 (1.2%) | 1 | 2/81 (2.5%) | 2 | 4/83 (4.8%) | 4 | 0/81 (0%) | 0 |
| General disorders | ||||||||
| Asthenia | 2/82 (2.4%) | 3 | 3/81 (3.7%) | 3 | 1/83 (1.2%) | 1 | 1/81 (1.2%) | 1 |
| Injection site erythema | 2/82 (2.4%) | 3 | 1/81 (1.2%) | 2 | 4/83 (4.8%) | 10 | 5/81 (6.2%) | 9 |
| Injection site pain | 5/82 (6.1%) | 6 | 1/81 (1.2%) | 1 | 4/83 (4.8%) | 5 | 2/81 (2.5%) | 14 |
| Pyrexia | 0/82 (0%) | 0 | 0/81 (0%) | 0 | 4/83 (4.8%) | 4 | 3/81 (3.7%) | 3 |
| Infections and infestations | ||||||||
| Acute sinusitis | 2/82 (2.4%) | 2 | 3/81 (3.7%) | 4 | 2/83 (2.4%) | 2 | 2/81 (2.5%) | 4 |
| Bronchitis | 8/82 (9.8%) | 8 | 4/81 (4.9%) | 5 | 2/83 (2.4%) | 3 | 5/81 (6.2%) | 7 |
| Gastroenteritis | 3/82 (3.7%) | 3 | 2/81 (2.5%) | 2 | 5/83 (6%) | 5 | 2/81 (2.5%) | 2 |
| Influenza | 6/82 (7.3%) | 8 | 10/81 (12.3%) | 11 | 5/83 (6%) | 5 | 2/81 (2.5%) | 2 |
| Nasopharyngitis | 12/82 (14.6%) | 15 | 11/81 (13.6%) | 15 | 5/83 (6%) | 9 | 7/81 (8.6%) | 11 |
| Pharyngitis | 2/82 (2.4%) | 2 | 4/81 (4.9%) | 4 | 8/83 (9.6%) | 13 | 4/81 (4.9%) | 5 |
| Rhinitis | 5/82 (6.1%) | 5 | 3/81 (3.7%) | 3 | 3/83 (3.6%) | 3 | 2/81 (2.5%) | 2 |
| Sinusitis | 4/82 (4.9%) | 5 | 10/81 (12.3%) | 11 | 4/83 (4.8%) | 4 | 6/81 (7.4%) | 10 |
| Upper respiratory tract infection | 12/82 (14.6%) | 19 | 6/81 (7.4%) | 6 | 16/83 (19.3%) | 23 | 20/81 (24.7%) | 32 |
| Urinary tract infection | 6/82 (7.3%) | 6 | 7/81 (8.6%) | 9 | 7/83 (8.4%) | 7 | 2/81 (2.5%) | 3 |
| Viral upper respiratory tract infection | 5/82 (6.1%) | 7 | 1/81 (1.2%) | 4 | 0/83 (0%) | 0 | 3/81 (3.7%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 2/82 (2.4%) | 2 | 3/81 (3.7%) | 3 | 3/83 (3.6%) | 3 | 2/81 (2.5%) | 3 |
| Pain in extremity | 2/82 (2.4%) | 2 | 1/81 (1.2%) | 1 | 3/83 (3.6%) | 3 | 3/81 (3.7%) | 4 |
| Nervous system disorders | ||||||||
| Dizziness | 5/82 (6.1%) | 5 | 2/81 (2.5%) | 2 | 5/83 (6%) | 15 | 0/81 (0%) | 0 |
| Headache | 8/82 (9.8%) | 11 | 13/81 (16%) | 20 | 5/83 (6%) | 9 | 6/81 (7.4%) | 7 |
| Migraine | 1/82 (1.2%) | 1 | 4/81 (4.9%) | 5 | 1/83 (1.2%) | 1 | 1/81 (1.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Asthma | 25/82 (30.5%) | 41 | 28/81 (34.6%) | 53 | 20/83 (24.1%) | 29 | 31/81 (38.3%) | 64 |
| Cough | 0/82 (0%) | 0 | 2/81 (2.5%) | 2 | 2/83 (2.4%) | 2 | 3/81 (3.7%) | 3 |
| Oropharyngeal pain | 0/82 (0%) | 0 | 2/81 (2.5%) | 2 | 3/83 (3.6%) | 3 | 2/81 (2.5%) | 2 |
| Rhinitis allergic | 7/82 (8.5%) | 7 | 5/81 (6.2%) | 5 | 1/83 (1.2%) | 1 | 3/81 (3.7%) | 4 |
| Skin and subcutaneous tissue disorders | ||||||||
| Pruritus | 1/82 (1.2%) | 1 | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 3 | 3/81 (3.7%) | 3 |
| Rash | 3/82 (3.7%) | 4 | 2/81 (2.5%) | 2 | 1/83 (1.2%) | 2 | 4/81 (4.9%) | 5 |
| Vascular disorders | ||||||||
| Hypertension | 2/82 (2.4%) | 3 | 4/81 (4.9%) | 4 | 3/83 (3.6%) | 3 | 0/81 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
Results Point of Contact
| Name/Title | Joe Parker, MD |
|---|---|
| Organization | MedImmune |
| Phone | 301-398-0000 |
| parkerJ@medimmune.com |
- MI-CP198