SIENA: Steroids In Eosinophil Negative Asthma
Study Details
Study Description
Brief Summary
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Detailed Description
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Mometasone then Tiotropium then Placebo Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo |
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Names:
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo
|
Experimental: Mometasone then Placebo then Tiotropium Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD |
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Names:
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo
|
Experimental: Placebo then Mometasone then Tiotropium Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD |
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Names:
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo
|
Experimental: Placebo then Tiotropium then Mometasone Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID |
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Names:
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo
|
Experimental: Tiotropium then Placebo then Mometasone Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID |
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Names:
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo
|
Experimental: Tiotropium then Mometasone then Placebo Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo |
Drug: Mometasone 220mcg BID
Mometasone is an ICS
Other Names:
Drug: Tiotropium Respimat 5mcg QD
Tiotropium is a LMA
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. [End of 12-week treatment period]
This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response.
Secondary Outcome Measures
- Treatment Failure [End of 12-week treatment period]
Treatment Failure includes: Awakening from asthma three or more times in a two-week period or on two consecutive nights, or Using albuterol for relief of symptoms four or more times/day for two or more consecutive days, or Albuterol has been relieving symptoms for less than four hours after each treatment over a 12-hour period, or Using albuterol for relief of symptoms daily for seven days, and this use exceeds two times the weekly use of albuterol in the baseline period, or exercise induces unusual breathlessness
- Annualized Asthma Control Days [End of 12-week treatment period]
Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365.
- Forced Expiratory Volume at One Second (FEV1) Percent of Predicted [End of 12-week treatment period]
FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height.
- Peak Expiratory Flow Rate [End of 12-week treatment period]
Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways.
- Asthma Exacerbations [End of 12-week treatment period]
Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following: FEV1 <50% of baseline on 2 consecutive measurements FEV1 <40% of predicted on 2 consecutive measurements Use of ≥ 16 puffs of "as needed" β-agonist per 24 hours for a period of 48 hours Use of oral/parenteral corticosteroid due to asthma
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Physician-diagnosed asthma for at least previous 12 months.
-
Able to perform reproducible spirometry.
-
Baseline FEV1≥70% of predicted.
-
Asthma confirmed either by:
-
Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR
-
Methacholine PC20 ≤ 16 mg/ml
-
At least 1 of the following indications for chronic controller therapy:
-
Asthma Symptoms > 2 days/week OR
-
Nocturnal Asthma Symptoms > 2 nights/month OR
-
Short-acting beta-agonist use for symptom control > 2 days/week
-
For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
-
Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.
Exclusion Criteria:
-
Chronic inhaled or oral corticosteroid therapy.
-
Use of inhaled or oral corticosteroid therapy within 6 weeks.
-
New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
-
Use of omalizumab within 3 months.
-
History of:
-
bladder-neck obstruction, urinary retention or benign prostatic hyperplasia
-
narrow angle glaucoma
-
significant cardiovascular disorders and arrhythmias
-
life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
-
Respiratory tract infection within past 6 weeks.
-
History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of age, or > 5 pack-years total if < 18 years of age.
-
Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Arizona College of Medicine | Tucson | Arizona | United States | 85724 |
2 | UCSF Benioff Children's Hospital | San Francisco | California | United States | 94143 |
3 | University of California at San Francisco | San Francisco | California | United States | 94143 |
4 | National Jewish Health | Denver | Colorado | United States | 80206 |
5 | Nemours Children's Clinic | Jacksonville | Florida | United States | 32207 |
6 | Nemours Children's Clinic | Orlando | Florida | United States | 32827 |
7 | Emory University | Atlanta | Georgia | United States | 30322 |
8 | Northwestern Memorial Hospital | Chicago | Illinois | United States | 60611 |
9 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
10 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
11 | Ann and Robert H. Lurie Children's Hospital | Chicago | Illinois | United States | 60614 |
12 | University of Chicago | Chicago | Illinois | United States | 60637 |
13 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
14 | Children's Hospital Boston | Boston | Massachusetts | United States | 02115 |
15 | St. Louis Children's Hospital | Saint Louis | Missouri | United States | 63110 |
16 | Washington University | Saint Louis | Missouri | United States | 63110 |
17 | Columbia University Medical Center | New York | New York | United States | 10032 |
18 | Duke University School of Medicine | Durham | North Carolina | United States | 27110 |
19 | North Carolina Clinical Research | Raleigh | North Carolina | United States | 27607 |
20 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
21 | Rainbow Babies and Children's Hospital, Case Western Reserve University | Cleveland | Ohio | United States | 44106 |
22 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
23 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
24 | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | United States | 15224 |
25 | University of Wisconsin-Madison | Madison | Wisconsin | United States | 53792 |
Sponsors and Collaborators
- Milton S. Hershey Medical Center
- National Heart, Lung, and Blood Institute (NHLBI)
Investigators
- Study Chair: William Busse, M.D., University of Wisconsin, Madison
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- AsthmaNet 007
- 1U10HL098115
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Mometasone Then Tiotropium Then Placebo | Mometasone Then Placebo Then Tiotropium | Placebo Then Mometasone Then Tiotropium | Placebo Then Tiotropium Then Mometasone | Tiotropium Then Placebo Then Mometasone | Tiotropium Then Mometasone Then Placebo |
---|---|---|---|---|---|---|
Arm/Group Description | Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo |
Period Title: Overall Study | ||||||
STARTED | 49 | 48 | 50 | 51 | 47 | 50 |
Completed 1st Period | 44 | 47 | 45 | 48 | 46 | 45 |
Completed 2nd Period | 41 | 41 | 41 | 46 | 42 | 41 |
Completed 3rd Period | 40 | 40 | 40 | 45 | 38 | 38 |
COMPLETED | 40 | 40 | 40 | 45 | 38 | 38 |
NOT COMPLETED | 9 | 8 | 10 | 6 | 9 | 12 |
Baseline Characteristics
Arm/Group Title | Mometasone Then Tiotropium Then Placebo | Mometasone Then Placebo Then Tiotropium | Placebo Then Mometasone Then Tiotropium | Placebo Then Tiotropium Then Mometasone | Tiotropium Then Placebo Then Mometasone | Tiotropium Then Mometasone Then Placebo | Total |
---|---|---|---|---|---|---|---|
Arm/Group Description | Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo Mometasone 220mcg BID: Mometasone is an ICS Tiotropium Respimat 5mcg QD: Tiotropium is a LMA Placebo | Total of all reporting groups |
Overall Participants | 49 | 48 | 50 | 51 | 47 | 50 | 295 |
Age (years) [Mean (Standard Deviation) ] | |||||||
Mean (Standard Deviation) [years] |
32.3
(15.3)
|
32.6
(13.8)
|
33.2
(13.9)
|
30.0
(14.8)
|
30.8
(12.5)
|
28.2
(12.9)
|
31.2
(13.9)
|
Sex: Female, Male (Count of Participants) | |||||||
Female |
29
59.2%
|
30
62.5%
|
32
64%
|
33
64.7%
|
27
57.4%
|
33
66%
|
184
62.4%
|
Male |
20
40.8%
|
18
37.5%
|
18
36%
|
18
35.3%
|
20
42.6%
|
17
34%
|
111
37.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||||
Hispanic or Latino |
6
12.2%
|
4
8.3%
|
4
8%
|
7
13.7%
|
7
14.9%
|
7
14%
|
35
11.9%
|
Not Hispanic or Latino |
43
87.8%
|
44
91.7%
|
46
92%
|
44
86.3%
|
40
85.1%
|
43
86%
|
260
88.1%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
2
4.1%
|
2
4.2%
|
2
4%
|
3
5.9%
|
0
0%
|
2
4%
|
11
3.7%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
13
26.5%
|
14
29.2%
|
15
30%
|
16
31.4%
|
14
29.8%
|
16
32%
|
88
29.8%
|
White |
34
69.4%
|
32
66.7%
|
33
66%
|
31
60.8%
|
32
68.1%
|
30
60%
|
192
65.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
1
2%
|
1
2.1%
|
2
4%
|
4
1.4%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||||||
United States |
49
100%
|
48
100%
|
50
100%
|
51
100%
|
47
100%
|
50
100%
|
295
100%
|
Forced expiratory volume at one second (FEV1) Percent of Predicted (percentage of predicted FEV1) [Mean (Standard Deviation) ] | |||||||
Mean (Standard Deviation) [percentage of predicted FEV1] |
90.6
(11.5)
|
91.5
(11.2)
|
92.0
(11.8)
|
93.8
(12.4)
|
91.7
(13.6)
|
91.6
(12.5)
|
91.9
(12.1)
|
Asthma Control Test (units on a scale) [Mean (Standard Deviation) ] | |||||||
Mean (Standard Deviation) [units on a scale] |
21.3
(2.3)
|
21.2
(2.5)
|
21.1
(2.7)
|
20.9
(2.2)
|
20.9
(2.8)
|
21.1
(2.5)
|
21.1
(2.5)
|
Sputum differential count - Percent eosinophils (percentage of cells) [Median (Inter-Quartile Range) ] | |||||||
Median (Inter-Quartile Range) [percentage of cells] |
0.1
|
0.4
|
0.4
|
0.2
|
0.2
|
0.2
|
0.2
|
Blood differential count - Percent eosinophils (percentage of cells) [Median (Inter-Quartile Range) ] | |||||||
Median (Inter-Quartile Range) [percentage of cells] |
2.3
|
4.0
|
3.0
|
3.2
|
3.0
|
2.8
|
3.0
|
Outcome Measures
Title | Pairwise Comparison of Treatments Based on Composite Measure Using Treatment Failures, Asthma Control Days, and Percent Predicted FEV1. |
---|---|
Description | This composite outcome uses a hierarchical method to ascertain differences in asthma control. For each participant, treatments are first compared to see if they differ in terms of treatment failures. If one treatment results in no treatment failures and another treatment does, it is deemed the superior treatment and no further comparisons are made. If treatment superiority cannot be assigned by treatment failures, then they are compared by asthma control days (ACDs). If one treatment yields at least 31 annualized ACDs more than another, it is deemed the superior treatment. If treatment superiority still cannot be assigned by ACDs, then they are compared by percent predicted FEV1 at the end of a treatment period. If one treatment yields at least 5% greater FEV1 than another, it is deemed the superior treatment. If treatment superiority cannot be assigned by exacerbations, ACDs or FEV1, then that participant is classified as having no differential response. |
Time Frame | End of 12-week treatment period |
Outcome Measure Data
Analysis Population Description |
---|
For each pairwise comparison (mometasone vs. placebo and tiotropium vs. placebo), participants were required to complete both of the relevant treatment periods in order to be included in the analysis. |
Arm/Group Title | Eosinophil Low | Eosinophil High |
---|---|---|
Arm/Group Description | Participants with sputum eosinophils < 2% at study entry | Participants with sputum eosinophils >= 2% at study entry |
Measure Participants | 184 | 67 |
Mometesone superior to placebo |
74
151%
|
35
72.9%
|
Placebo superior to mometasone |
56
114.3%
|
12
25%
|
Mometesone equal to placebo |
46
93.9%
|
20
41.7%
|
Tiotropium superior to placebo |
80
163.3%
|
25
52.1%
|
Placebo superior to tiotropium |
52
106.1%
|
19
39.6%
|
Tiotropium equal to placebo |
49
100%
|
18
37.5%
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Eosinophil Low |
---|---|---|
Comments | The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.14 |
Comments | ||
Method | exact binomial test | |
Comments | a priori threshold for significance was 0.025 |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | Eosinophil Low |
---|---|---|
Comments | The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. The trial was designed to provide power of 0.85 for a 0.20 difference between the proportions being compared at a significance level of 0.025. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.029 |
Comments | a priori threshold for significance was 0.025 | |
Method | exact binomial test | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | Eosinophil High |
---|---|---|
Comments | The null hypothesis was that, among those participants for which either mometasone is not equal to placebo, the proportion for which mometasone is superior to placebo is equal to the proportion for which placebo is superior to mometasone. This was an exploratory analysis and there were no power considerations. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.001 |
Comments | this analysis is considered exploratory | |
Method | exact binomial test | |
Comments |
Statistical Analysis 4
Statistical Analysis Overview | Comparison Group Selection | Eosinophil High |
---|---|---|
Comments | The null hypothesis was that, among those participants for which either tiotropium is not equal to placebo, the proportion for which tiotropium is superior to placebo is equal to the proportion for which placebo is superior to tiotropium. This was an exploratory analysis and there were no power considerations. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.45 |
Comments | this analysis is considered exploratory | |
Method | exact binomial test | |
Comments |
Title | Treatment Failure |
---|---|
Description | Treatment Failure includes: Awakening from asthma three or more times in a two-week period or on two consecutive nights, or Using albuterol for relief of symptoms four or more times/day for two or more consecutive days, or Albuterol has been relieving symptoms for less than four hours after each treatment over a 12-hour period, or Using albuterol for relief of symptoms daily for seven days, and this use exceeds two times the weekly use of albuterol in the baseline period, or exercise induces unusual breathlessness |
Time Frame | End of 12-week treatment period |
Outcome Measure Data
Analysis Population Description |
---|
participants who completed the treatment period with data to evaluate treatment failure outcome |
Arm/Group Title | Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD |
---|---|---|---|
Arm/Group Description | The placebo treatment period for all participants. | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD |
Measure Participants | 254 | 255 | 258 |
Count of Participants [Participants] |
29
59.2%
|
29
60.4%
|
35
70%
|
Title | Annualized Asthma Control Days |
---|---|
Description | Asthma Control Days (ACD) are based on patient completed electronic daily diaries, and are defined as: A day with no rescue albuterol use (pre-exercise albuterol will not be counted), no non-study asthma medications, no daytime asthma symptoms (shortness of breath, wheezing, chest tightness, phlegm/mucus rated as mild, moderate or severe, or cough rated as moderate or severe), no nighttime asthma symptoms, no unscheduled healthcare visits for asthma, and no PEF < 80% of predetermined baseline. Annualized ACD are calculated as the proportion of ACD during the treatment period multiplied by 365. |
Time Frame | End of 12-week treatment period |
Outcome Measure Data
Analysis Population Description |
---|
participants who completed the treatment period with data to evaluate asthma control days |
Arm/Group Title | Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD |
---|---|---|---|
Arm/Group Description | The placebo treatment period for all participants | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD |
Measure Participants | 216 | 225 | 228 |
Mean (Standard Deviation) [days] |
179
(137)
|
186
(141)
|
176
(139)
|
Title | Forced Expiratory Volume at One Second (FEV1) Percent of Predicted |
---|---|
Description | FEV1, expressed as percent of predicted FEV1 based on age, sex, race, and height. |
Time Frame | End of 12-week treatment period |
Outcome Measure Data
Analysis Population Description |
---|
participants who completed the treatment period and were able to provide FEV1 measurements |
Arm/Group Title | Eosinophil Low - Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD |
---|---|---|---|
Arm/Group Description | The placebo treatment period for all participants | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD |
Measure Participants | 254 | 247 | 252 |
Mean (Standard Deviation) [percentage of predicted FEV1] |
92
(14)
|
94
(13)
|
95
(14)
|
Title | Peak Expiratory Flow Rate |
---|---|
Description | Peak expiratory flow rate is a person's maximum speed of expiration. It measures the airflow through the bronchi and thus the degree of obstruction in the airways. |
Time Frame | End of 12-week treatment period |
Outcome Measure Data
Analysis Population Description |
---|
participants who completed the treatment period and were able to provide FEV1 measurements |
Arm/Group Title | Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD |
---|---|---|---|
Arm/Group Description | The placebo treatment period for all participants | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD |
Measure Participants | 253 | 249 | 256 |
Mean (Standard Deviation) [liters per minute] |
476
(117)
|
485
(117)
|
497
(117)
|
Title | Asthma Exacerbations |
---|---|
Description | Asthma exacerbations are more severe episodes of acute worsening, defined by meeting one or more of the following: FEV1 <50% of baseline on 2 consecutive measurements FEV1 <40% of predicted on 2 consecutive measurements Use of ≥ 16 puffs of "as needed" β-agonist per 24 hours for a period of 48 hours Use of oral/parenteral corticosteroid due to asthma |
Time Frame | End of 12-week treatment period |
Outcome Measure Data
Analysis Population Description |
---|
participants who completed the treatment period with data to evaluate exacerbations |
Arm/Group Title | Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD |
---|---|---|---|
Arm/Group Description | The placebo treatment period for all participants | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD |
Measure Participants | 254 | 255 | 258 |
Count of Participants [Participants] |
1
2%
|
3
6.3%
|
5
10%
|
Adverse Events
Time Frame | Each participant was followed over the course of three 12-week treatment periods for a total of 36 weeks. The adverse events recorded below are reported at the treatment period level and represent 12 weeks of "at risk" exposure time. | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||
Arm/Group Title | Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD | |||
Arm/Group Description | The placebo treatment period for all participants | The mometasone treatment period for all participants. Mometasone administered 220mcg BID | The tiotropium treatment period for all participants. Tiotropium administered 5mcg QD | |||
All Cause Mortality |
||||||
Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/276 (0%) | 0/275 (0%) | 0/271 (0%) | |||
Serious Adverse Events |
||||||
Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/276 (0%) | 6/275 (2.2%) | 2/271 (0.7%) | |||
Gastrointestinal disorders | ||||||
Partial bowel obstruction. | /276 (NaN) | 0/275 (0%) | 0 | 1/271 (0.4%) | 1 | |
Acute appendicitis without mention of peritonitis | /276 (NaN) | 1/275 (0.4%) | 1 | 0/271 (0%) | 0 | |
Musculoskeletal and connective tissue disorders | ||||||
closed fracture of lower end of humerus | /276 (NaN) | 1/275 (0.4%) | 1 | 0/271 (0%) | 0 | |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Hydatidiform mole | /276 (NaN) | 0/275 (0%) | 0 | 1/271 (0.4%) | 1 | |
malignant neoplasm of skin of other and unspecified parts of face | /276 (NaN) | 1/275 (0.4%) | 1 | 0/271 (0%) | 0 | |
Pregnancy, puerperium and perinatal conditions | ||||||
pregnancy | /276 (NaN) | 1/275 (0.4%) | 1 | 0/271 (0%) | 0 | |
Psychiatric disorders | ||||||
Unspecified nonpsychotic mental disorder | /276 (NaN) | 1/275 (0.4%) | 1 | 0/271 (0%) | 0 | |
Adjustment disorder with depressed mood | /276 (NaN) | 1/275 (0.4%) | 1 | 0/271 (0%) | 0 | |
Other (Not Including Serious) Adverse Events |
||||||
Placebo | Mometasone 220mcg BID | Tiotropium Respimat 5mcg QD | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 45/276 (16.3%) | 47/275 (17.1%) | 38/271 (14%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Acute nasopharyngitis | 37/276 (13.4%) | 42 | 33/275 (12%) | 38 | 29/271 (10.7%) | 37 |
Acute URI not otherwise specified | 8/276 (2.9%) | 9 | 16/275 (5.8%) | 18 | 11/271 (4.1%) | 13 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | David Mauger |
---|---|
Organization | Penn State University |
Phone | 717-531-7178 |
dmauger@psu.edu |
- AsthmaNet 007
- 1U10HL098115