Trial Outcomes & Findings for Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age (NCT NCT01156792)
NCT ID: NCT01156792
Last Updated: 2017-04-05
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.
COMPLETED
PHASE2
162 participants
End of Week 6
2017-04-05
Participant Flow
A total of 341 participants (par.) were screened, and 162 participants were randomized. A protocol amendment necessitated withdrawal of all male participants and further enrollment of female participants only.
Par. meeting screening criteria, self-administered open-label fluticasone propionate 100 micrograms (µg) twice daily for 14-28 days. Eligible par. were assigned to 1 of 10 treatment sequences, receiving 4 of 5 double-blind treatments. Par. aged 12-14 years did not receive montelukast. Rescue medication (albuterol inhalation) was provided.
Participant milestones
| Measure |
All Treatments Combined
In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
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|---|---|
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Overall Study
STARTED
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162
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Overall Study
COMPLETED
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93
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Overall Study
NOT COMPLETED
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69
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Reasons for withdrawal
| Measure |
All Treatments Combined
In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
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|---|---|
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Overall Study
Adverse Event
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1
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Overall Study
Lack of Efficacy
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36
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Overall Study
Protocol Violation
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6
|
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Overall Study
Lost to Follow-up
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3
|
|
Overall Study
Physician Decision
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3
|
|
Overall Study
Withdrawal by Subject
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9
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Overall Study
other Sponsor Decision (Protocol Amendme
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11
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Baseline Characteristics
Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
Baseline characteristics by cohort
| Measure |
All Treatments Combined
n=162 Participants
In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
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|---|---|
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Age, Continuous
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36.8 Years
STANDARD_DEVIATION 14.43 • n=5 Participants
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Sex: Female, Male
Female
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151 Participants
n=5 Participants
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Sex: Female, Male
Male
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11 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
African American/African Heritage
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42 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
American Indian or Alaska Native
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1 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
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1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
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115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Missing
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: End of Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 300 mg
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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FP + Montelukast
n=94 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
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FP / Salmeterol
n=93 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period
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2.36 Liters (L)
Standard Error 0.03
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2.39 Liters (L)
Standard Error 0.03
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2.40 Liters (L)
Standard Error 0.03
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2.42 Liters (L)
Standard Error 0.03
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2.43 Liters (L)
Standard Error 0.03
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SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period
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349.19 Liters/minute (L/min)
Standard Error 4.08
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350.14 Liters/minute (L/min)
Standard Error 4.06
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354.96 Liters/minute (L/min)
Standard Error 4.07
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354.17 Liters/minute (L/min)
Standard Error 4.05
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361.33 Liters/minute (L/min)
Standard Error 4.05
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SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
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FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period
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354.06 L/min
Standard Error 4.03
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355.71 L/min
Standard Error 4.02
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359.16 L/min
Standard Error 4.03
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358.88 L/min
Standard Error 4.01
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364.35 L/min
Standard Error 4.00
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SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.
Outcome measures
| Measure |
FP + Placebo
n=93 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 300 mg
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups
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352.37 L/min
Standard Error 3.90
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356.16 L/min
Standard Error 3.91
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356.52 L/min
Standard Error 3.90
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—
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—
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SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
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FP + GSK2190915 100 mg
n=90 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period
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2.26 Score on a scale
Standard Error 0.12
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2.26 Score on a scale
Standard Error 0.12
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2.15 Score on a scale
Standard Error 0.12
|
2.22 Score on a scale
Standard Error 0.12
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2.25 Score on a scale
Standard Error 0.12
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SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=90 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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|---|---|---|---|---|---|
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Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period
|
2.17 Number of inhalations
Standard Error 0.13
|
2.14 Number of inhalations
Standard Error 0.13
|
2.03 Number of inhalations
Standard Error 0.13
|
2.09 Number of inhalations
Standard Error 0.13
|
2.08 Number of inhalations
Standard Error 0.13
|
SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced ("symptom-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
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|---|---|---|---|---|---|
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Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period
|
30.84 Percentage of days
Standard Error 3.04
|
33.51 Percentage of days
Standard Error 3.02
|
36.14 Percentage of days
Standard Error 3.03
|
34.88 Percentage of days
Standard Error 3.01
|
35.45 Percentage of days
Standard Error 3.02
|
SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced ("symptom-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period
|
37.21 Percentage of nights
Standard Error 2.87
|
38.22 Percentage of nights
Standard Error 2.85
|
40.55 Percentage of nights
Standard Error 2.85
|
37.70 Percentage of nights
Standard Error 2.84
|
38.47 Percentage of nights
Standard Error 2.85
|
SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used ("rescue-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period
|
40.44 Percentage of days
Standard Error 3.05
|
42.43 Percentage of days
Standard Error 3.03
|
42.59 Percentage of days
Standard Error 3.04
|
42.77 Percentage of days
Standard Error 3.02
|
41.96 Percentage of days
Standard Error 3.03
|
SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used ("rescue-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period
|
45.12 Percentage of nights
Standard Error 2.87
|
45.69 Percentage of nights
Standard Error 2.85
|
48.79 Percentage of nights
Standard Error 2.86
|
45.32 Percentage of nights
Standard Error 2.85
|
43.98 Percentage of nights
Standard Error 2.85
|
SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population. Only those participants available at the specified time point were analyzed.
Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Outcome measures
| Measure |
FP + Placebo
n=92 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=92 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=93 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=95 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period
|
37.21 Percentage of nights
Standard Error 2.87
|
38.22 Percentage of nights
Standard Error 2.85
|
40.55 Percentage of nights
Standard Error 2.85
|
37.70 Percentage of nights
Standard Error 2.84
|
38.47 Percentage of nights
Standard Error 2.85
|
SECONDARY outcome
Timeframe: Week 4 to Week 6Population: ITT Population.
Participants were withdrawn if they met any of the following three criteria for 'lack of efficacy': 1) Clinic FEV1 below the FEV1 'Stability Limit' value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF 'Stability Limit' for more than 3 days, or if \>= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher's Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.
Outcome measures
| Measure |
FP + Placebo
n=104 Participants
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=103 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=96 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=99 Participants
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=104 Participants
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period
|
9 Number of participants
|
5 Number of participants
|
3 Number of participants
|
7 Number of participants
|
5 Number of participants
|
Adverse Events
FP + Placebo
FP + GSK2190915 100 mg
FP + GSK2190915 300 mg
FP + Montelukast
FP / Salmeterol
Serious adverse events
| Measure |
FP + Placebo
n=104 participants at risk
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=103 participants at risk
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=96 participants at risk
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=99 participants at risk
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=104 participants at risk
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/104 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.97%
1/103 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.00%
0/96 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.00%
0/99 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.00%
0/104 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
Other adverse events
| Measure |
FP + Placebo
n=104 participants at risk
Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 100 mg
n=103 participants at risk
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + GSK2190915 300 mg
n=96 participants at risk
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
FP + Montelukast
n=99 participants at risk
Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
|
FP / Salmeterol
n=104 participants at risk
Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
5.8%
6/104 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.97%
1/103 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
1.0%
1/96 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
1.0%
1/99 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.96%
1/104 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
1.9%
2/104 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
1.9%
2/103 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
3.1%
3/96 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.00%
0/99 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
0.00%
0/104 • On-treatment adverse events (AE) and serious adverse events (SAE) were collected from the start of treatment until the follow-up contact (a maximum of 178 days).
On-treatment AEs and SAEs are reported for the ITT Population.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER