Trial Outcomes & Findings for Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response (NCT NCT01128569)
NCT ID: NCT01128569
Last Updated: 2017-01-18
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. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.
COMPLETED
PHASE2
52 participants
Baseline and Day 29 of each treatment period (up to Study Day 197)
2017-01-18
Participant Flow
Participants were screened within 42 days of the first dose, conducted over 2 days (not consecutive days). During this time, a methacholine challenge and an allergen challenge test were performed. Participants meeting all inclusion criteria and none of the exclusion criteria were randomized to 3 study treatment periods, each lasting 28 days.
This study was a multi-center, randomized, double-blind, placebo controlled, three-period crossover study in mild asthmatic male and female participants. Following the Run-in period, participants were randomized to 1 of 6 treatment sequences of placebo, FF 100 micrograms (µg) once daily (OD), and FF/VI 100/25 µg OD.
Participant milestones
| Measure |
Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg
Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg
Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo
Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg
Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg
Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo
Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
9
|
8
|
9
|
8
|
9
|
9
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Treatment Period 1
COMPLETED
|
9
|
8
|
9
|
8
|
9
|
9
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
9
|
8
|
9
|
8
|
9
|
9
|
|
Washout Period 1
COMPLETED
|
9
|
8
|
8
|
8
|
9
|
9
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
9
|
8
|
8
|
8
|
9
|
9
|
|
Treatment Period 2
COMPLETED
|
9
|
7
|
8
|
8
|
9
|
9
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
9
|
7
|
8
|
8
|
9
|
9
|
|
Washout Period 2
COMPLETED
|
9
|
7
|
8
|
8
|
9
|
9
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
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0
|
0
|
|
Treatment Period 3
STARTED
|
9
|
7
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8
|
8
|
9
|
9
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Treatment Period 3
COMPLETED
|
9
|
7
|
8
|
8
|
9
|
9
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg
Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg
Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo
Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg
Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg
Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo
Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|---|---|---|
|
Washout Period 1
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Randomised Study Comparing the Effects of Inhaled Fluticasone Furoate (FF)/Vilanterol (VI; GW642444M) Combination and FF on an Allergen Induced Asthmatic Response
Baseline characteristics by cohort
| Measure |
Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences
n=52 Participants
All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
|---|---|
|
Age, Continuous
|
35.4 Years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
|
Gender
Female
|
18 Participants
n=5 Participants
|
|
Gender
Male
|
34 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
48 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29 of each treatment period (up to Study Day 197)Population: Intent-to-Treat (ITT) Population: par. randomized to treatment who received \>=1 dose of study drug. Only those par. available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, par.-level Baseline, period level Baseline, country, sex, and age.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants (par.) were exposed to an allergen (administered by inhalation) 22-23 hours after dosing on Day 28. FEV1 was measured 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours post-allergen challenge on Day 29. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1 were recorded at 1-minute intervals, and the best was taken as the post-saline value. The FEV1 weighted mean was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Weighted mean change from Baseline is calculated as the weighted mean FEV1 value on Day 29 minus the Baseline value. The Baseline FEV1 value was the post-saline value on Day 29.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
FF 100 µg OD
n=49 Participants
Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
FF/VI 100/25 µg OD
n=46 Participants
Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|
|
Weighted Mean Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Between 0-2 Hours, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
|
-0.372 Liters
Standard Error 0.0557
|
-0.210 Liters
Standard Error 0.0549
|
-0.227 Liters
Standard Error 0.0550
|
SECONDARY outcome
Timeframe: Baseline and Day 29 of each treatment period (up to Study Day 197)Population: ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model analysis of covariance (ANCOVA) with fixed effects of treatment, period, participant-level BL, period level BL, country, sex, and age. Change from BL was calculated as the value on Day 29 minus the BL value.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes (min) after inhalation of saline, 3 single measurements of FEV1were recorded at 1-min intervals, and the best was taken as the post-saline value. The maximum change (i.e., drop in FEV1) from post-saline Baseline (BL) is defined by ordering all of the change from BL values for the 5 min, 10 min, 15 min, 20 min, 30 min, and 45 min and the 1 hour, 1.5 hours, and 2 hours post-allergen challenge and selecting the largest change (i.e., drop in FEV1) from the BL value. If there were no negative change values, indicating a worse FEV1 value as compared to the BL value, the smallest change in FEV1, indicating an improvement from the BL value, was selected. The BL FEV1 value was the post-saline value on Day 29.
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
FF 100 µg OD
n=49 Participants
Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
FF/VI 100/25 µg OD
n=46 Participants
Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|
|
Maximum Percent Decrease From Baseline in FEV1 Between 0 2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
|
-24.991 Percent change
Standard Error 2.0736
|
-14.040 Percent change
Standard Error 2.0435
|
-13.206 Percent change
Standard Error 2.0491
|
SECONDARY outcome
Timeframe: Baseline and Day 29 of each treatment period (up to Study Day 197)Population: ITT Population. Only those participants available at the specified time points were analyzed. Analysis was performed using mixed model ANCOVA with fixed effects of treatment, period, participant-level Baseline, period level Baseline, country, sex, and age.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Participants were exposed to an allergen 22-23 hours after dosing on Day 28. Immediately prior to the exposure of allergen and starting at 2 minutes after inhalation of saline, 3 single measurements of FEV1were recorded at 1-minute intervals, and the best was taken as the post-saline value. The minimum FEV1 over 0-2 hours post-allergen challenge (PAC) (minimum early asthmatic response) was the minimum value of all of the PAC time points up to and including 2 hours PAC (i.e., minimum over 5 minutes (min), 10 min, 15 min, 20 min, 30 min, and 45 min and 1 hour, 1.5 hours, and 2 hours). Change from Baseline was calculated using the post-saline FEV1 on Day 29 as Baseline. Minimum FEV1 absolute change from Baseline between 0-2 hour, following the 22-23 hour post-treatment allergen challenge was calculated as the minimum change value on Day 29 minus the Baseline value
Outcome measures
| Measure |
Placebo
n=45 Participants
Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
FF 100 µg OD
n=49 Participants
Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
FF/VI 100/25 µg OD
n=46 Participants
Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|
|
Minimum FEV1 Absolute Change From Baseline Between 0-2 Hour, Following the 22-23 Hour Post-treatment Allergen Challenge on Day 29 of Each Treatment Period
|
-0.809 Liters
Standard Error 0.0775
|
-0.479 Liters
Standard Error 0.0765
|
-0.478 Liters
Standard Error 0.0767
|
SECONDARY outcome
Timeframe: From the start of study medication until Follow-up/Early Withdrawal (up to 197 days)Population: ITT Population
The number of participants with treatment-emergent AEs was measured. A treatment-emergent adverse event is defined as any event not present prior to the initiation of the treatments, or any event already present that worsens in either intensity of frequency following exposure to the treatments.
Outcome measures
| Measure |
Placebo
n=51 Participants
Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
FF 100 µg OD
n=51 Participants
Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
FF/VI 100/25 µg OD
n=51 Participants
Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (AEs)
|
20 participants
|
22 participants
|
18 participants
|
Adverse Events
Placebo
FF 100 µg OD
FF/VI 100/25 µg OD
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=51 participants at risk
Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
|
FF 100 µg OD
n=51 participants at risk
Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
FF/VI 100/25 µg OD
n=51 participants at risk
Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
17.6%
9/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
21.6%
11/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
9.8%
5/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
5.9%
3/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
3/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
3.9%
2/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
5.9%
3/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
0.00%
0/51 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up/Early Withdrawal (up to 197 days).
SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of study drug.
|
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