Study Of Allergic Rhinitis In Patients Who Also Have Asthma
Study Details
Study Description
Brief Summary
This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD |
Drug: fluticasone propionate/salmeterol (FSC)
fluticasone propionate/salmeterol DISKUS combination
Drug: montelukast (MON)
montelukast capsule
Drug: placebo nasal
vehicle placebo nasal spray
Drug: ADVAIR DISKUS
ADVAIR DISKUS
|
| Active Comparator: Fluticasone Propionate/Salmeterol (FSC) FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD |
Drug: fluticasone propionate/salmeterol (FSC)
fluticasone propionate/salmeterol DISKUS combination
Drug: placebo nasal
vehicle placebo nasal spray
Drug: ADVAIR DISKUS
ADVAIR DISKUS
Drug: placebo capsule
placebo capsule
|
| Active Comparator: Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD |
Drug: fluticasone propionate/salmeterol (FSC)
fluticasone propionate/salmeterol DISKUS combination
Drug: fluticasone propionate (FP)
fluticasone propionate aqueous nasal spray
Drug: ADVAIR DISKUS
ADVAIR DISKUS
Drug: placebo capsule
placebo capsule
|
| Active Comparator: Montelukast (MON) Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD |
Drug: montelukast (MON)
montelukast capsule
Drug: placebo nasal
vehicle placebo nasal spray
Drug: placebo DISKUS
placebo DISKUS
|
Outcome Measures
Primary Outcome Measures
- Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
- Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work.
Secondary Outcome Measures
- Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS). [Baseline to 1-2 Weeks]
The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate)
- Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS) [Baseline To 1-2 Weeks]
The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time.
- Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.
- Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second.
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8.
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population [Baseline to Endpoint (weeks 3-4)]
Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).
- Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population [Baseline to Endpoint (weeks 3-4)]
Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days).
Eligibility Criteria
Criteria
INCLUSION CRITERIA:
A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
-
Consent: A signed and dated written informed consent must be obtained from the subject or subject's legally acceptable representative prior to study participation. An informed consent must be signed prior to any change in the subject's medication regimen, including withholding medications prior to Visit 1.
-
Gender: Male or female. Females are eligible to participate only if they are currently not pregnant and not lactating. Females of child-bearing potential will be required to use a highly effective method for avoiding pregnancy (i.e., contraception with a failure rate of <1% per year). Female subjects of child-bearing potential will undergo a urine pregnancy test at Visits 1, 2, 3, and 4. Any female who becomes pregnant during the study will be withdrawn. Female subjects should not be enrolled if they plan to become pregnant during the time of study participation.
-
Age: 15 years and older.
-
Asthma Diagnosis: A diagnosis of persistent asthma, for at least three months, as defined by the following American Thoracic Society definition:
Asthma is a clinical syndrome characterized by increased responsiveness of the tracheobronchial tree to a variety of stimuli. The major symptoms of asthma are paroxysms of dyspnea, wheezing, and cough, which may vary from mild and almost undetectable to severe and unremitting (status asthmaticus). The primary physiological manifestation of this hyperresponsiveness is variable airway obstruction. This can take the form of spontaneous fluctuations in the severity of obstruction, substantial improvements in the severity of obstruction following bronchodilators or corticosteroids, or increased obstruction caused by drugs or other stimuli [American Thoracic Society, 1987a].
NOTE: Intermittent and seasonal asthma, as well as exercise-induced bronchospasm alone, are excluded.
-
Asthma Therapy: 3 months' prior and current use of one of the following asthma therapies, with no change in regimen during the month prior to Visit 1:
-
Scheduled or as-needed inhaled or oral short-acting beta2-agonist (SABA). Subjects must be able to replace their current short-acting beta2-agonist with albuterol/salbutamol, to be used only on an as-needed basis for the duration of the study.
-
Allowed non-corticosteroid controller therapy (e.g., anticholinergics and cromolyn).
-
One of the following inhaled corticosteroids taken at the corresponding daily dose:
criteria.
Inhaled Corticosteroid (Total Daily Dose) Beclomethasone dipropionate (≤420mcg) Beclomethasone dipropionate HFA (≤240mcg) Budesonide (≤400mcg) Flunisolide (≤1000mcg) Fluticasone propionate inhalation aerosol (≤220mcg) Fluticasone propionate inhalation powder (≤250mcg) Mometasone furoate (≤220mcg) Triamcinolone acetonide (≤1000mcg) Subjects taking ADVAIR 100/50mcg BID are eligible to replace ADVAIR with FLOVENT HFA 110mcg BID for 14 days prior to Visit 1. This change will be at the Investigator's clinical discretion, taking each individual's current and past asthma stability into account. The subject must be aware of the risks and benefits of switching their medication and acknowledge this by signing an informed consent prior to any change in the subject's medication regimen.
- Asthma Severity: An FEV1 between 65% - 95% of predicted value at Visit 1 after withholding asthma medications as detailed in the protocol.
At Visit 2, subjects must also be experiencing minimum asthma symptoms as defined in Section 5.2.3, "Randomization Criteria", and in Section 6.2 of the protocol.
Predicted FEV1 will be based on the National Health and Nutrition Examination Survey (NHANES III) predicted normal values [Hankinson, 1999].
-
Rhinitis Diagnosis: A diagnosis of seasonal allergic rhinitis defined as follows:
-
A clinical history (written or verbal confirmation) of allergic rhinitis with the seasonal onset and offset of nasal allergy symptoms during each of the previous 2 relevant allergy seasons (captured in source documents only).
AND •A positive skin test reaction to a geographically relevant seasonal allergen, as determined by the skin prick method, within 24 months prior to or at Visit 1.
For the purposes of this study, a positive skin test reaction is defined as a wheal diameter that is at least 3mm greater than diluent control using 1:20 W:V glycerinated solution.
•At Visit 2, subjects must also be experiencing minimum rhinitis symptoms as defined in Section 5.2.3, "Randomization Criteria", and in Section 6.2 of the protocol.
- Geographical Location: Active residence within a geographical region where exposure to a relevant seasonal allergen is expected to be significant during the entire study period.
Note: The principal investigator is responsible for tracking and recording pollen counts for geographically relevant seasonal allergens throughout the entire study. Alternatively, this information may be obtained from a reputable source from within the same geographical area.
EXCLUSION CRITERIA:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
-
Currently Diagnosed with Life-Threatening Asthma: An episode or episodes of asthma requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures.
-
Asthma Instability: Hospitalization for asthma within 6 months of Visit 1.
-
Concurrent Respiratory Disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, or any other respiratory abnormalities other than asthma.
-
Nasal Obstruction: Severe physical obstruction of the nose (e.g., deviated septum) that could affect the deposition of double-blind intranasal study drug.
-
Nasal History: History of nasal septal perforation or recent nasal septal surgery.
-
Other Concurrent Conditions/Diseases: Any evidence of rhinitis medicamentosa, history of glaucoma and/or cataracts or ocular herpes simplex, or any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
The list of additional excluded conditions/diseases includes, but is not limited to:
cardiac arrhythmias; congestive heart failure; coronary artery disease; poorly controlled diabetes, poorly controlled hypertension, poorly controlled peptic ulcer, hematologic, hepatic, or renal disease; immunologic compromise; current malignancy; current or quiescent tuberculosis, and Cushing's or Addison's disease.
-
Drug Allergy: Any immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, leukotriene modifier, or any intranasal, inhaled, or systemic corticosteroid therapy, or sensitivity to aspirin or other NSAIDS. Subjects with severe milk protein allergies are also excluded from participation.
-
Respiratory Tract Infections: Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 14 days immediately preceding Visit 1, or for which antibiotic therapy has not been completed at least 14 days prior to Visit 1.
-
Concurrent Medications: Concurrent use of any of the following medications that may affect the course of asthma, rhinitis, or interact with sympathomimetic amines or montelukast.
-
Beta-blockers
-
tricyclic antidepressants
-
monoamine oxidase inhibitors
-
phenobarbital
-
rifampin
-
ritonavir
-
ketoconazole
-
Systemic Corticosteroids: Use of oral or parenteral systemic corticosteroids within 28 days of Visit 1, or requirement for more than two courses of parenteral systemic corticosteroids for asthma within 6 months of Visit 1.
NOTE: Topical hydrocortisone cream or ointment (1% or less) is permitted during the study.
- Excluded Rhinitis Medications: The following rhinitis medications must be withheld during the corresponding "exclusion period" prior to Visit 1 and are not allowed any time during the study, unless dispensed as double-blind study drug:
Medication (Exclusion Period Prior to Visit 1) Intranasal and ocular corticosteroids (28 days) Leukotriene modifiers (e.g., Singulair, Accolate, Zyflo) (28 days) Intranasal and ocular cromolyn (14 days) Long-acting antihistamines (e.g., loratadine, cetirizine) (10 days) Short-acting antihistamines (includes prescription and OTC) (72 hours) Oral and intranasal decongestants (72 hours) Intranasal anticholinergics (e.g., Atrovent) (24 hours)
- Excluded Asthma Medications: The following asthma medications must be withheld during the corresponding "exclusion period" prior to Visit 1.
These asthma medications, with the exception of an inhaled corticosteroid/long-acting beta2-agonist combination product and Xolair, may be continued during the run-in period of the study (between Visits 1 and 2), but must be withheld prior to Visit 2 for the appropriate "exclusion period" as shown below.
These asthma medications are not allowed any time after randomization at Visit 2 (with the exception of as as-needed rescue albuterol/salbutamol), unless dispensed as double-blind study drug:
Medicationª (Exclusion Period Prior to Visit 1 and/or Visit 2) Inhaled corticosteroid/long-acting beta2-agonist combination product (e.g., ADVAIR) (14 days) Inhaled anticholinergics (e.g., Atrovent, Combivent, Spiriva) (24 hours) Theophylline products (48 hours) Inhaled cromolyn or nedocromil (24 hours) Inhaled corticosteroids (12 hours) Long-acting beta2-agonists (e.g., Foradil, SEREVENT™) (14 days) Oral beta2-agonists (12 hours) Inhaled short-acting beta2-agonists^b (e.g., Proventil) (6 hours) Xolair (12 months)
-
For the leukotriene modifier "exclusion period" prior to Visit 1, refer to Exclusion Criterion 11.
-
Replaced at Visit 1 with albuterol/salbutamol.
-
Ophthalmic preparations: Use of artificial tears, eyewashes, homeopathic preparations, irrigation solutions, lubricants, sympathomimetic preparations, vasoconstrictors, or combinations of any of the aforementioned products during the study.
-
Immunosuppressive Medications: Use of immunosuppressive medications during the study.
NOTE: Immunotherapy for the treatment of allergies is allowed during the study, provided that it was not initiated within 30 days of Visit 1, the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
-
Positive Pregnancy Test: A positive pregnancy test at Visit 1.
-
Tobacco Use: Greater than a 10 pack-year history of cigarette smoking or use of any tobacco products within 1 year of Visit 1. This includes cigarettes, cigars, pipe, chewing tobacco, and snuff.
Note: Pack years = number of cigarettes smoked per day divided by 20, multiplied by the number of years of smoking.
-
Questionable Validity of Consent: Any infirmity or disability that would limit the subject's consent or geographic location that would limit the compliance for scheduled visits.
-
Investigational Medications: Use of any investigational drug within 30 days of Visit
-
3rd shift/Nighttime employment: Any employment during the nighttime hours (10 p.m. - 6 a.m.) or 3rd shift.
-
Site affiliation: Participation of anyone associated with the administration of the study or their immediate family members
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Birmingham | Alabama | United States | 35209 |
| 2 | GSK Investigational Site | Glendale | Arizona | United States | 85304 |
| 3 | GSK Investigational Site | Scottsdale | Arizona | United States | 85251 |
| 4 | GSK Investigational Site | Tucson | Arizona | United States | 85712 |
| 5 | GSK Investigational Site | Hot Springs | Arkansas | United States | 71913 |
| 6 | GSK Investigational Site | Berkeley | California | United States | 94705 |
| 7 | GSK Investigational Site | Huntington Beach | California | United States | 92647 |
| 8 | GSK Investigational Site | Long Beach | California | United States | 90806 |
| 9 | GSK Investigational Site | Los Angeles | California | United States | 90025 |
| 10 | GSK Investigational Site | Rancho Mirage | California | United States | 92270 |
| 11 | GSK Investigational Site | Riverside | California | United States | 92506 |
| 12 | GSK Investigational Site | Roseville | California | United States | 95678 |
| 13 | GSK Investigational Site | San Diego | California | United States | 92103 |
| 14 | GSK Investigational Site | San Diego | California | United States | 92120 |
| 15 | GSK Investigational Site | San Jose | California | United States | 95117 |
| 16 | GSK Investigational Site | San Jose | California | United States | 95128 |
| 17 | GSK Investigational Site | Stockton | California | United States | 95207 |
| 18 | GSK Investigational Site | Vista | California | United States | 92083 |
| 19 | GSK Investigational Site | Boulder | Colorado | United States | 80304 |
| 20 | GSK Investigational Site | Colorado Springs | Colorado | United States | 80907 |
| 21 | GSK Investigational Site | Fort Collins | Colorado | United States | 80526 |
| 22 | GSK Investigational Site | Lakewood | Colorado | United States | 80401 |
| 23 | GSK Investigational Site | Brandon | Florida | United States | 33511 |
| 24 | GSK Investigational Site | Coral Gables | Florida | United States | 33134 |
| 25 | GSK Investigational Site | Ocala | Florida | United States | 34471 |
| 26 | GSK Investigational Site | Pensacola | Florida | United States | 32504 |
| 27 | GSK Investigational Site | Tallahassee | Florida | United States | 32308 |
| 28 | GSK Investigational Site | Albany | Georgia | United States | 31707 |
| 29 | GSK Investigational Site | Atlanta | Georgia | United States | 30342 |
| 30 | GSK Investigational Site | Columbus | Georgia | United States | 31904 |
| 31 | GSK Investigational Site | Gainesville | Georgia | United States | 30501 |
| 32 | GSK Investigational Site | Lawrenceville | Georgia | United States | 30045 |
| 33 | GSK Investigational Site | Savannah | Georgia | United States | 31405 |
| 34 | GSK Investigational Site | Savannah | Georgia | United States | 31406 |
| 35 | GSK Investigational Site | Chicago | Illinois | United States | 60612 |
| 36 | GSK Investigational Site | Springfield | Illinois | United States | 62704 |
| 37 | GSK Investigational Site | Indianapolis | Indiana | United States | 46208 |
| 38 | GSK Investigational Site | South Bend | Indiana | United States | 46617 |
| 39 | GSK Investigational Site | Iowa City | Iowa | United States | 52242 |
| 40 | GSK Investigational Site | Overland Park | Kansas | United States | 66210 |
| 41 | GSK Investigational Site | Lexington | Kentucky | United States | 40536 |
| 42 | GSK Investigational Site | Louisville | Kentucky | United States | 40215 |
| 43 | GSK Investigational Site | Owensboro | Kentucky | United States | 42301 |
| 44 | GSK Investigational Site | Baton Rouge | Louisiana | United States | 70808 |
| 45 | GSK Investigational Site | Covington | Louisiana | United States | 70433 |
| 46 | GSK Investigational Site | Lafayette | Louisiana | United States | 70503 |
| 47 | GSK Investigational Site | Shreveport | Louisiana | United States | 71105 |
| 48 | GSK Investigational Site | Sunset | Louisiana | United States | 70584 |
| 49 | GSK Investigational Site | Baltimore | Maryland | United States | 21236 |
| 50 | GSK Investigational Site | North Andover | Massachusetts | United States | 01845 |
| 51 | GSK Investigational Site | Minneapolis | Minnesota | United States | 55402 |
| 52 | GSK Investigational Site | Jackson | Mississippi | United States | 39202 |
| 53 | GSK Investigational Site | Jefferson City | Missouri | United States | 65101 |
| 54 | GSK Investigational Site | Rolla | Missouri | United States | 65401 |
| 55 | GSK Investigational Site | St. Louis | Missouri | United States | 63141 |
| 56 | GSK Investigational Site | Warrensburg | Missouri | United States | 64093 |
| 57 | GSK Investigational Site | Lincoln | Nebraska | United States | 68505 |
| 58 | GSK Investigational Site | Omaha | Nebraska | United States | 68124 |
| 59 | GSK Investigational Site | Omaha | Nebraska | United States | 68130 |
| 60 | GSK Investigational Site | Omaha | Nebraska | United States | 68131 |
| 61 | GSK Investigational Site | Papillion | Nebraska | United States | 68046 |
| 62 | GSK Investigational Site | Forked River | New Jersey | United States | 08731 |
| 63 | GSK Investigational Site | Summit | New Jersey | United States | 07091 |
| 64 | GSK Investigational Site | Rochester | New York | United States | 14618 |
| 65 | GSK Investigational Site | Asheville | North Carolina | United States | 28801 |
| 66 | GSK Investigational Site | Raleigh | North Carolina | United States | 27607 |
| 67 | GSK Investigational Site | Canton | Ohio | United States | 44718 |
| 68 | GSK Investigational Site | Cincinnati | Ohio | United States | 45242 |
| 69 | GSK Investigational Site | Parma | Ohio | United States | 44129 |
| 70 | GSK Investigational Site | Oklahoma City | Oklahoma | United States | 73120 |
| 71 | GSK Investigational Site | Bend | Oregon | United States | 97701 |
| 72 | GSK Investigational Site | Portland | Oregon | United States | 97213 |
| 73 | GSK Investigational Site | Pittsburgh | Pennsylvania | United States | 15241 |
| 74 | GSK Investigational Site | Upland | Pennsylvania | United States | 19013 |
| 75 | GSK Investigational Site | Providence | Rhode Island | United States | 02906 |
| 76 | GSK Investigational Site | Charleston | South Carolina | United States | 29407 |
| 77 | GSK Investigational Site | Charleston | South Carolina | United States | 29414 |
| 78 | GSK Investigational Site | Greenville | South Carolina | United States | 29607 |
| 79 | GSK Investigational Site | Orangeburg | South Carolina | United States | 29118 |
| 80 | GSK Investigational Site | Simpsonville | South Carolina | United States | 29681 |
| 81 | GSK Investigational Site | Spartanburg | South Carolina | United States | 29303 |
| 82 | GSK Investigational Site | Chattanooga | Tennessee | United States | 37421 |
| 83 | GSK Investigational Site | Germantown | Tennessee | United States | 38138 |
| 84 | GSK Investigational Site | Knoxville | Tennessee | United States | 37909 |
| 85 | GSK Investigational Site | Savannah | Tennessee | United States | 38372 |
| 86 | GSK Investigational Site | Austin | Texas | United States | 78750 |
| 87 | GSK Investigational Site | Dallas | Texas | United States | 75230 |
| 88 | GSK Investigational Site | Dallas | Texas | United States | 75231-4307 |
| 89 | GSK Investigational Site | Dallas | Texas | United States | 75240 |
| 90 | GSK Investigational Site | Dallas | Texas | United States | 75246 |
| 91 | GSK Investigational Site | El Paso | Texas | United States | 79902 |
| 92 | GSK Investigational Site | El Paso | Texas | United States | 79925 |
| 93 | GSK Investigational Site | Houston | Texas | United States | 77054 |
| 94 | GSK Investigational Site | Houston | Texas | United States | 77070 |
| 95 | GSK Investigational Site | Kerrville | Texas | United States | 78028 |
| 96 | GSK Investigational Site | San Antonio | Texas | United States | 78205 |
| 97 | GSK Investigational Site | San Antonio | Texas | United States | 78229 |
| 98 | GSK Investigational Site | San Antonio | Texas | United States | 78233 |
| 99 | GSK Investigational Site | Waco | Texas | United States | 76708 |
| 100 | GSK Investigational Site | Salt Lake City | Utah | United States | 84121 |
| 101 | GSK Investigational Site | West Jordan | Utah | United States | 84084 |
| 102 | GSK Investigational Site | Danville | Virginia | United States | 24541 |
| 103 | GSK Investigational Site | Richmond | Virginia | United States | 23298 |
| 104 | GSK Investigational Site | Kirkland | Washington | United States | 98034 |
| 105 | GSK Investigational Site | Winnipeg | Manitoba | Canada | R3C 0N2 |
| 106 | GSK Investigational Site | Ajax | Ontario | Canada | L1S 2J5 |
| 107 | GSK Investigational Site | Brampton | Ontario | Canada | L6T 3T1 |
| 108 | GSK Investigational Site | Kanata | Ontario | Canada | K2L 3C8 |
| 109 | GSK Investigational Site | Mississauga | Ontario | Canada | L5A 3V4 |
| 110 | GSK Investigational Site | Niagara Falls | Ontario | Canada | L2G 1J4 |
| 111 | GSK Investigational Site | Ottawa | Ontario | Canada | K1N 6N5 |
| 112 | GSK Investigational Site | Ottawa | Ontario | Canada | K2C 3R2 |
| 113 | GSK Investigational Site | Sudbury | Ontario | Canada | P3E 1H5 |
| 114 | GSK Investigational Site | Quebec City | Quebec | Canada | G1V 4M6 |
| 115 | GSK Investigational Site | Trois Rivières | Quebec | Canada | G8T 7A1 |
| 116 | GSK Investigational Site | Tallinn | Estonia | 13419 | |
| 117 | GSK Investigational Site | Tartu | Estonia | 51014 | |
| 118 | GSK Investigational Site | Bialystok | Poland | 15-025 | |
| 119 | GSK Investigational Site | Bialystok | Poland | 15-274 | |
| 120 | GSK Investigational Site | Krakow | Poland | 31-023 | |
| 121 | GSK Investigational Site | Lodz | Poland | 93-513 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ADA103575
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) |
|---|---|---|---|---|
| Arm/Group Description | Flut Prop = Fluticasone Propionate. | |||
| Period Title: Overall Study | ||||
| STARTED | 182 | 182 | 180 | 181 |
| COMPLETED | 140 | 129 | 137 | 138 |
| NOT COMPLETED | 42 | 53 | 43 | 43 |
Baseline Characteristics
| Arm/Group Title | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) | Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) | Montelukast (MON) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD) | Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD). | Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD). | Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD. | Total of all reporting groups |
| Overall Participants | 182 | 180 | 182 | 181 | 725 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
33.0
(13.54)
|
34.5
(14.64)
|
34.9
(12.62)
|
34.5
(12.47)
|
34.2
(13.34)
|
| Gender (Count of Participants) | |||||
| Female |
115
63.2%
|
102
56.7%
|
120
65.9%
|
112
61.9%
|
449
61.9%
|
| Male |
67
36.8%
|
78
43.3%
|
62
34.1%
|
69
38.1%
|
276
38.1%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| White |
138
75.8%
|
138
76.7%
|
143
78.6%
|
145
80.1%
|
564
77.8%
|
| African American/African Heritage |
34
18.7%
|
35
19.4%
|
31
17%
|
30
16.6%
|
130
17.9%
|
| American Indian or Alaska Native |
0
0%
|
1
0.6%
|
1
0.5%
|
0
0%
|
2
0.3%
|
| Asian |
9
4.9%
|
5
2.8%
|
5
2.7%
|
5
2.8%
|
24
3.3%
|
| Native Hawaiian or other Pacific Islander |
1
0.5%
|
1
0.6%
|
1
0.5%
|
1
0.6%
|
4
0.6%
|
| Unknown |
0
0%
|
0
0%
|
1
0.5%
|
0
0%
|
1
0.1%
|
Outcome Measures
| Title | Mean Change From Baseline at Endpoint in Morning Peak Expiration Flow (PEF) for Intent-to-Treat Population |
|---|---|
| Description | Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work. |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. |
| Arm/Group Title | Fluticasone Prop/Salmeterol (FSC) | Montelukast (MON) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 179 | 181 |
| Mean (Standard Error) [L/min] |
26.4
(4.10)
|
3.6
(3.28)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fluticasone Prop/Salmeterol (FSC), Montelukast (MON) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 23.2 | |
| Confidence Interval |
() 95% 12.5 to 33.8 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 5.41 |
|
| Estimation Comments | Treatment Difference = FSC - MON | |
| Title | Mean Change From Baseline at Endpoint in Morning Peak Expiratory Flow (PEF) for Per Protocol Population |
|---|---|
| Description | Endpoint was defined as the average of the data reported from the last week of treatment. Data collected by patient throughout the treatment period between visits. The peak expiratory flow rate measures how fast a person can breathe out (exhale) air. It is one of many tests that measure how well your airways work. |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. |
| Arm/Group Title | Flut Prop/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 83 | 88 |
| Mean (Standard Error) [L/min] |
30.9
(4.92)
|
35.2
(6.41)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fluticasone Prop/Salmeterol (FSC), Montelukast (MON) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence | |
| Comments | Given estimates, and assuming a significance level of a=0.05, a sample size of 133 subjects per treatment was determined to be sufficient to provide 80% power to show equivalance. | |
| Statistical Test of Hypothesis | p-Value | <0.127 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | -8.9 | |
| Confidence Interval |
() 95% -24.6 to 6.9 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 8.00 |
|
| Estimation Comments | Treatment Difference=FSC+MON-FSC | |
| Title | Rhinitis: Mean Change From Baseline at 1-2 Weeks in Daytime Total Nasal Symptom Scores (D-TNNS). |
|---|---|
| Description | The sum of scores of each of the four daytime symptoms (nasal congestion, itching, rhinorrhea, and sneezing). Scale: 0=none (no sign/symptom evident)1=mild (sign/symptom clearly present; easily tolerated)2=moderate (definite awareness of sign/symptom that is bothersome but tolerable)3=severe (sign/symptom is hard to tolerate) |
| Time Frame | Baseline to 1-2 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Prop/Salmeterol/Montelukast (FSC+MON) | Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 181 | 181 |
| Mean (Standard Error) [Points on a Scale] |
-2.3
(0.16)
|
-3.0
(0.18)
|
| Title | Rhinitis: Mean Change From Baseline at 1-2 Weeks in Nightime Total Nasal Symptom Scores (N-TNSS) |
|---|---|
| Description | The scores of 3 nighttime symptoms (nasal congestion upon awakening, difficulty going to sleep due to nasal symptoms, nighttime awakenings due to nasal symptoms). Scale: 0=not noticeable, 1=noticeable but not bothersome, 2=noticeable and bothersome some of the time, 3=bothersome most of the time and/or very bothersome some of the time. |
| Time Frame | Baseline To 1-2 Weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC+FPANS and FSC+MON in the context of rhinitis measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS) | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 181 | 181 |
| Mean (Standard Error) [Points on a Scale] |
-2.0
(0.13)
|
1.7
(0.13)
|
| Title | Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Intent-to-Treat Population |
|---|---|
| Description | Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second. |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 178 | 180 |
| Mean (Standard Error) [L/sec] |
0.15
(0.02)
|
0.04
(0.03)
|
| Title | Asthma: Mean Change From Baseline at Endpoint in Predose Morning Forced Expiratory Volume (FEV1) for Per Protocol Population |
|---|---|
| Description | Endpoint was defined as the average of the last week's worth of evaluable data. The volume of air that can be forced out taking a deep breath, an important measure of pulmonary function. FEV1 is forced expiratory volume in one second. |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 83 | 88 |
| Mean (Standard Error) [L/sec] |
0.27
(0.04)
|
0.13
(0.04)
|
| Title | Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Intent-to-Treat Population |
|---|---|
| Description | Endpoint was defined as the average of the data reported from the last week of treatment.Asthma symptom scores and the subject-rated overall satisfaction with treatment, related to the percentage of asthma symptom-free days. Same scale used as in outcome 8. |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 179 | 181 |
| Mean (Standard Error) [Percentage of asthma symptom-free days] |
34.8
(2.94)
|
26.1
(2.83)
|
| Title | Asthma: Mean Change From Baseline at Endpoint in Percentage of Asthma Symptom-Free Days for Per Protocol Population |
|---|---|
| Description | Asthma symptom score:0=no symptoms,1=symptoms 1 short period,2=symptoms 2 or more short periods,3=symptoms most of day not affect activities,4=symptoms most of day did affect activities,5=symptoms severe.Overall satisfaction score:0=very dissatisfied,1=dissatisfied,2=slightly dissatisfied,3=neutral,4=slightly satisfied,5=satisfied 6=very satisfied |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 83 | 88 |
| Mean (Standard Error) [Percentage of asthma symptom-free days] |
34.8
(4.32)
|
37.1
(4.23)
|
| Title | Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol-Salbutamol Free Days for Intent-to-Treat Population |
|---|---|
| Description | Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days). |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat (ITT) population, the basis for superiority comparisons between FSC and MON in the context of asthma measures, included all subjects randomized to double-blind treatment. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 179 | 181 |
| Mean (Standard Error) [Percentage of rescue-free days] |
37.5
(2.84)
|
26.7
(2.92)
|
| Title | Asthma: Mean Change From Baseline at Endpoint in Percentage of Albuterol/Salbutamol-Free Days for Per Protocol Population |
|---|---|
| Description | Endpoint was defined as the average of the data reported from the last week of treatment. Albuterol/salbutamol use (related to percentage of asthma rescue-free days). |
| Time Frame | Baseline to Endpoint (weeks 3-4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Per Protocol population, the basis for equivalence comparison between FSC and FSC+MON in terms of asthma measures, included subjects from the ITT population who did not deviate significantly from the protocol. Families of secondary efficacy measures were each adjusted for multiplicity using Hochberg's method. |
| Arm/Group Title | Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) |
|---|---|---|
| Arm/Group Description | ||
| Measure Participants | 83 | 88 |
| Mean (Standard Error) [Percentage of rescue-free days] |
41.2
(3.97)
|
42.9
(4.20)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) | ||||
| Arm/Group Description | Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD). | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD) | Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD). | Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD. | ||||
All Cause Mortality |
||||||||
| Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/182 (0%) | 1/182 (0.5%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Gastrointestinal disorders | ||||||||
| Gastrooesophageal reflux disease | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Infections and infestations | ||||||||
| Appendicitis | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Spinal fracture | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) | Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) | Fluticasone Propionate/Salmeterol (FSC) | Montelukast (MON) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 32/182 (17.6%) | 32/182 (17.6%) | 42/180 (23.3%) | 41/181 (22.7%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear disorder | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Ear pain | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Eye disorders | ||||||||
| Conjunctivitis | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Eye pruritis | 2/182 (1.1%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Dry eye | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Eye swelling | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Diarrhoea | 2/182 (1.1%) | 0/182 (0%) | 0/180 (0%) | 3/181 (1.7%) | ||||
| Nausea | 2/182 (1.1%) | 1/182 (0.5%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Abdominal pain upper | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 2/181 (1.1%) | ||||
| Vomiting | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 3/181 (1.7%) | ||||
| Food poisoning | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Oral pain | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Aphthous stomatitis | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Dyspepsia | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Stomach discomfort | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| General disorders | ||||||||
| Pyrexia | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 2/181 (1.1%) | ||||
| Chest pain | 0/182 (0%) | 1/182 (0.5%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Injection site pain | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Oedema peripheral | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Hepatobiliary disorders | ||||||||
| Cholelithiasis | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Immune system disorders | ||||||||
| Anaphylactic reaction | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Food allergy | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Hypersensitivity | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Infections and infestations | ||||||||
| Upper respiratory tract infection | 1/182 (0.5%) | 1/182 (0.5%) | 3/180 (1.7%) | 4/181 (2.2%) | ||||
| Nasopharyngitis | 1/182 (0.5%) | 3/182 (1.6%) | 4/180 (2.2%) | 0/181 (0%) | ||||
| Sinusitis | 3/182 (1.6%) | 0/182 (0%) | 4/180 (2.2%) | 1/181 (0.6%) | ||||
| Gastroenteritis viral | 0/182 (0%) | 1/182 (0.5%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Oral candidiasis | 0/182 (0%) | 1/182 (0.5%) | 2/180 (1.1%) | 0/181 (0%) | ||||
| Gastroenteritis | 2/182 (1.1%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Influenza | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Lower respiratory tract infection | 0/182 (0%) | 2/182 (1.1%) | 0/180 (0%) | 0/181 (0%) | ||||
| Acute sinusitis | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Appendicitis | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Bronchitis | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Clostridial infection | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Cystitis | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Eye infection | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Laryngitis | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Oral herpes | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Otitis media | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Pharyngitis streptococcal | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Respiratory tract infection viral | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Tooth abscess | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Urinary tract infection | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Viral infection | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Viral upper respiratory tract infection | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Skin laceration | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Arthropod sting | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Joint injury | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Joint sprain | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Meniscus lesion | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Muscle strain | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Neck injury | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Procedural pain | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Road traffic accident | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Tooth fracture | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Investigations | ||||||||
| Weight increased | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 2/182 (1.1%) | 1/182 (0.5%) | 3/180 (1.7%) | 1/181 (0.6%) | ||||
| Myalgia | 1/182 (0.5%) | 2/182 (1.1%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Muscle spasms | 1/182 (0.5%) | 1/182 (0.5%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Arthralgia | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Musculoskeletal pain | 0/182 (0%) | 1/182 (0.5%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Musculoskeletal stiffness | 2/182 (1.1%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Arthritis | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Bursitis | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Muscle twitching | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Pain in extremity | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Tendonitis | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Nervous system disorders | ||||||||
| Headache | 7/182 (3.8%) | 7/182 (3.8%) | 8/180 (4.4%) | 8/181 (4.4%) | ||||
| Sinus headache | 0/182 (0%) | 2/182 (1.1%) | 3/180 (1.7%) | 1/181 (0.6%) | ||||
| Migraine | 1/182 (0.5%) | 1/182 (0.5%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Dizziness | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Tremor | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Psychiatric disorders | ||||||||
| Anorgasmia | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Insomnia | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Middle insomnia | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Dysmenorrhoea | 0/182 (0%) | 1/182 (0.5%) | 1/180 (0.6%) | 3/181 (1.7%) | ||||
| Menorrhagia | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Metrorrhagia | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Ovarian cyst | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Epistaxis | 0/182 (0%) | 1/182 (0.5%) | 4/180 (2.2%) | 3/181 (1.7%) | ||||
| Pharyngolaryngeal pain | 1/182 (0.5%) | 1/182 (0.5%) | 2/180 (1.1%) | 4/181 (2.2%) | ||||
| Cough | 1/182 (0.5%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Nasal congestion | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Nasal discomfort | 0/182 (0%) | 1/182 (0.5%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Respiratory tract congestion | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 1/181 (0.6%) | ||||
| Dry throat | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Nasal dryness | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Nasal polyps | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Rhinitis allergic | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Rhinitis perennial | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Rhinorrhoea | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Sinus congestion | 0/182 (0%) | 0/182 (0%) | 1/180 (0.6%) | 0/181 (0%) | ||||
| Throat irritation | 0/182 (0%) | 0/182 (0%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Rash | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 1/181 (0.6%) | ||||
| Dermatitis contact | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Petechiae | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
| Surgical and medical procedures | ||||||||
| Shoulder operation | 1/182 (0.5%) | 0/182 (0%) | 0/180 (0%) | 0/181 (0%) | ||||
| Vascular disorders | ||||||||
| Haematoma | 0/182 (0%) | 1/182 (0.5%) | 0/180 (0%) | 0/181 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centres of a multi-centre trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
- ADA103575