Trial Outcomes & Findings for Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics. (NCT NCT01400906)
NCT ID: NCT01400906
Last Updated: 2018-08-13
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 were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Day 6 of each treatment period (up to 11 weeks)
Results posted on
2018-08-13
Participant Flow
A total of 36 participants were enrolled; however, 1 participant was categorized as a screen failure following randomization and wasn't dosed with study drug. Thus, 35 of the 36 participants enrolled received treatment.
Participant milestones
| Measure |
Sequence 1: Placebo, FP 100 µg, FP 500 µg
Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.
|
Sequence 2: Placebo, FP 500 µg, FP 100 µg
Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
|
Sequence 3: FP 100 µg, Placebo, FP 500 µg
Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
|
Sequence 4: FP 100 µg, FP 500 µg, Placebo
Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
|
Sequence 5: FP 500 µg, Placebo, FP 100 µg
Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
|
Sequence 6: FP 500 µg, FP 100 µg, Placebo
Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
|
|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Treatment Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 1
STARTED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Washout Period 1
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Washout Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
STARTED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Treatment Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
STARTED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Washout Period 2
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Washout Period 2
NOT COMPLETED
|
0
|
0
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0
|
0
|
0
|
0
|
|
Treatment Period 3
STARTED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Treatment Period 3
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inhalation of Corticosteroids in Smoking and Non-smoking Asthmatics.
Baseline characteristics by cohort
| Measure |
Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences
n=35 Participants
All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.
|
|---|---|
|
Age, Continuous
|
30.0 Years
STANDARD_DEVIATION 7.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage (HER)
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central/South Asian HER
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese/East Asian HER/South East Asian HER
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 6 of each treatment period (up to 11 weeks)Population: Pharmacodynamic (PD) Population: all participants in the All Subjects Population (all participants who received at least one dose of study medication) who had a post-dose FEV1 assessment in the same period. Only those participants who were smokers 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. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=17 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=17 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Late Asthmatic Response (LAR) - Smokers: Absolute Change From Saline in Minimum Forced Expiratory Volume in One Second (FEV1) Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period
|
-0.592 Liters
Interval -0.793 to -0.391
|
-0.420 Liters
Interval -0.617 to -0.224
|
-0.431 Liters
Interval -0.627 to -0.234
|
PRIMARY outcome
Timeframe: Day 6 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants who were non-smokers 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. Participants were exposed to an allergen 1 hr after dosing on Day 6. Minimum FEV1 over 4-10 hours post-allergen challenge is the minimum value of all of the post-saline time points between 4 and 10 hrs post-allergen challenge, inclusive of the 4 hr and 10 hr timepoints (i.e., minimum over 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs). Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=18 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=18 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
LAR - Non-smokers: Absolute Change From Saline in Minimum FEV1 Between 4-10 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period
|
-1.034 Liters
Interval -1.225 to -0.843
|
-0.396 Liters
Interval -0.587 to -0.205
|
-0.373 Liters
Interval -0.563 to -0.182
|
PRIMARY outcome
Timeframe: Day 6 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants who were smokers 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. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=17 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=17 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
LAR - Smokers: Absolute Change From Saline in Weighted Mean (WM) FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period
|
-0.364 Liters
Interval -0.512 to -0.215
|
-0.188 Liters
Interval -0.334 to -0.043
|
-0.198 Liters
Interval -0.344 to -0.053
|
PRIMARY outcome
Timeframe: Day 6 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants were non-smokers 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. Participants were exposed to an allergen 1 hour after dosing on Day 6. The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. LAR WM FEV1 was measured at 4 hrs, 4.5 hrs, 5 hrs, 5.5 hrs, 6 hrs, 6.5 hrs, 7 hrs, 7.5 hrs, 8 hrs, 8.5 hrs, 9 hrs, 9.5 hrs, and 10 hrs post-allergen challenge on Day 6. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=18 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=18 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=18 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
LAR - Non-smokers: Absolute Change From Saline in WM FEV1 Between 4-10 Hrs Following Post-treatment Allergen Challenge on Day 6 of Each Treatment Period
|
-0.688 Liters
Interval -0.829 to -0.547
|
-0.212 Liters
Interval -0.353 to -0.071
|
-0.158 Liters
Interval -0.299 to -0.018
|
SECONDARY outcome
Timeframe: Day 6 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.
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 1 hr after dosing on Day 6. Minimum FEV1 over 0-2 hrs post-allergen challenge (Minimum EAR) is the minimum value of all of the post-allergen challenge timepoints up to and including 2 hours post-allergen challenge (i.e., minimum over 5 minutes \[min\], 10 min, 15 min, 20 min, 30 min, 45 min and 1 hr, 1.5 hrs, and 2 hrs). The WM FEV1 was derived by calculating the area under the curve, and then dividing the value by the relevant time interval. Absolute change from saline at each time point was calculated as the highest allergen challenge FEV1 value minus the highest saline FEV1 value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=35 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=35 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period
Minimum FEV1, Smokers, n=16, 17, 17
|
-0.799 Liters
Interval -1.02 to -0.579
|
-0.769 Liters
Interval -0.986 to -0.551
|
-0.817 Liters
Interval -1.034 to -0.6
|
|
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period
Minimum FEV1, Non-smokers, n=18, 18, 18
|
-0.984 Liters
Interval -1.194 to -0.773
|
-0.743 Liters
Interval -0.953 to -0.532
|
-0.676 Liters
Interval -0.887 to -0.465
|
|
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period
WM FEV1, Smokers, n=16, 17, 17
|
-0.423 Liters
Interval -0.567 to -0.279
|
-0.303 Liters
Interval -0.445 to -0.161
|
-0.362 Liters
Interval -0.504 to -0.22
|
|
Early Asthmatic Response (EAR): Absolute Change From Saline in Minimum FEV1 and WM FEV1 Between 0-2 Hours (Hrs) After Allergen Challenge on Day 6 of Each Treatment Period
WM FEV1, Non-smokers, n=18, 18, 18
|
-0.531 Liters
Interval -0.669 to -0.394
|
-0.349 Liters
Interval -0.486 to -0.211
|
-0.311 Liters
Interval -0.448 to -0.173
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 6, and Day 7Population: PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Baseline FEV1 was measured on Day 1 pre-dose administration. FEV1 was measured on Day 1 post-dose, on Day 6 (prior to allergen challenge), and on Day 7 pre dose administration. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=35 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=35 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7
Day 6, Non-smokers, n=18, 18, 18
|
-0.028 Liters
Interval -0.108 to 0.052
|
0.114 Liters
Interval 0.034 to 0.194
|
0.058 Liters
Interval -0.022 to 0.138
|
|
Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7
Day 1, Smokers, n=17, 17, 17
|
0.156 Liters
Interval 0.063 to 0.249
|
0.216 Liters
Interval 0.123 to 0.309
|
0.177 Liters
Interval 0.084 to 0.27
|
|
Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7
Day 6, Smokers, n=16, 17, 17
|
-0.081 Liters
Interval -0.166 to 0.003
|
0.016 Liters
Interval -0.067 to 0.098
|
0.032 Liters
Interval -0.05 to 0.115
|
|
Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7
Day 7, Smokers, n=17, 17, 17
|
-0.123 Liters
Interval -0.279 to 0.032
|
-0.083 Liters
Interval -0.239 to 0.072
|
-0.053 Liters
Interval -0.208 to 0.103
|
|
Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7
Day 1, Non-smokers, n=16, 18, 17
|
0.201 Liters
Interval 0.107 to 0.294
|
0.237 Liters
Interval 0.147 to 0.327
|
0.217 Liters
Interval 0.125 to 0.309
|
|
Absolute Change From Baseline in FEV1 Post-dose on Day 1, Day 6 (Prior to Allergen Challenge), and Day 7
Day 7, Non-smokers, n=18, 18, 18
|
-0.341 Liters
Interval -0.492 to -0.19
|
-0.079 Liters
Interval -0.23 to 0.072
|
0.012 Liters
Interval -0.138 to 0.163
|
SECONDARY outcome
Timeframe: Day 7 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.
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 inhaled doubling increments of methacholine until a \>=20% decrease in FEV1 from the post-saline value was achieved.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=35 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=35 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period
Smokers, n=16, 17, 17
|
0.579 milligrams per milliliter
Interval 0.391 to 0.855
|
1.233 milligrams per milliliter
Interval 0.845 to 1.798
|
1.439 milligrams per milliliter
Interval 0.985 to 2.1
|
|
Provocative Concentration of Methacholine Resulting in a 20% Reduction in FEV1 (PC20) on Day 7 of Each Treatment Period
Non smokers, n=18, 17, 18
|
0.514 milligrams per milliliter
Interval 0.356 to 0.743
|
1.488 milligrams per milliliter
Interval 1.02 to 2.172
|
2.080 milligrams per milliliter
Interval 1.441 to 3.001
|
SECONDARY outcome
Timeframe: Day 6 and Day 7 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the PD Population.
The concentration of eNO was measured on Day 6 pre-dose and on Day 7 post-study medication administration. eNO was measured 3 times at each time point, and all 3 measurements were recorded. The mean of the 3 measurements was calculated and was used in the derivation of summary statistics.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=35 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=35 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period
Day 6, Pre-dose, Smokers, n=16, 17, 17
|
21.117 Parts per billion
Standard Deviation 15.2894
|
12.718 Parts per billion
Standard Deviation 6.5018
|
14.049 Parts per billion
Standard Deviation 14.8450
|
|
Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period
Day 7, Post-dose, Smokers, n=17, 17, 17
|
45.167 Parts per billion
Standard Deviation 34.8859
|
16.602 Parts per billion
Standard Deviation 10.5155
|
16.298 Parts per billion
Standard Deviation 10.8249
|
|
Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period
Day 6, Pre-dose, Non-smokers, n=17, 18, 18
|
62.980 Parts per billion
Standard Deviation 30.8968
|
37.252 Parts per billion
Standard Deviation 17.8334
|
32.572 Parts per billion
Standard Deviation 17.4064
|
|
Concentration of Exhaled Nitric Oxide (eNO) on Day 6 and Day 7 of Each Treatment Period
Day 7, Post-dose, Non-smokers, n=18, 18, 18
|
98.837 Parts per billion
Standard Deviation 42.4567
|
42.869 Parts per billion
Standard Deviation 25.4944
|
34.989 Parts per billion
Standard Deviation 16.0285
|
SECONDARY outcome
Timeframe: Day 7 of each treatment period (up to 11 weeks)Population: PD Population. Only those participants available at the specified time points were analyzed (represented by n=X, X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the PD Population.
Sputum induction was performed using hypertonic saline solution to collect an adequate sample of secretions from lungs. The collected sputum was analyzed for neutrophil and eosinophil counts. Sputum induction was performed after methacholine challenge and post-dose administration on Day 7. Zero values are imputed to 0.001 for this analysis. Data were adjusted for the following covariates: period, smoking status, treatment, participant-level Baseline, period-level Baseline, and treatment by smoking status interaction.
Outcome measures
| Measure |
Placebo
n=35 Participants
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=35 Participants
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=35 Participants
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period
Eosinophil count, Smokers, n=7, 7, 5
|
0.400 10^4 cells per gram of sputum
Interval 0.027 to 5.858
|
0.489 10^4 cells per gram of sputum
Interval 0.03 to 8.02
|
0.459 10^4 cells per gram of sputum
Interval 0.0 to 444.058
|
|
Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period
Eosinophil count, Non-smokers, n=11, 11, 10
|
6.911 10^4 cells per gram of sputum
Interval 0.851 to 56.129
|
0.878 10^4 cells per gram of sputum
Interval 0.105 to 7.356
|
0.144 10^4 cells per gram of sputum
Interval 0.01 to 2.162
|
|
Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period
Neutrophil count, Smokers, n=7, 7, 5
|
96.231 10^4 cells per gram of sputum
Interval 44.622 to 207.532
|
50.313 10^4 cells per gram of sputum
Interval 22.948 to 110.308
|
87.699 10^4 cells per gram of sputum
Interval 13.432 to 572.592
|
|
Neutrophil and Eosinophil Cell Counts in Induced Sputum on Day 7 of Each Treatment Period
Neutrophil count, Non-smokers, n=11, 11, 10
|
78.768 10^4 cells per gram of sputum
Interval 43.324 to 143.209
|
49.532 10^4 cells per gram of sputum
Interval 27.052 to 90.692
|
36.561 10^4 cells per gram of sputum
Interval 17.389 to 76.869
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
FP 100 µg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
FP 500 µg
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=35 participants at risk
Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 100 µg
n=35 participants at risk
Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
FP 500 µg
n=35 participants at risk
Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.7%
2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
5.7%
2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
5.7%
2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Rhinitis
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Headache
|
8.6%
3/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
5.7%
2/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
8.6%
3/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Oral pruritus
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Hypersensitivity
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Eye disorders
Eye irritation
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.9%
1/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
0.00%
0/35 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication to the end of the treatment period (up to 16 weeks).
SAEs and non-serious AEs were reported for members of the All Subjects Population, comprised of all participants who received at least one dose of study medication.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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