A Phase 2 interventional study of FF/GSK573719 and FF/GSK573719 in Asthma, sponsored by GlaxoSmithKline. Completed at 32 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Diagnostic
Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control.
Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 421 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
100mcg, inhaled
Drug: FF
100/25mcg inhaled
Drug: FF/VI
100/15.6-250mcg inhaled
Drug: FF/GSK573719
100/15.6
100/31.25
100/62.5
100/125
100/250
100
100/25
Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1)
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.
Time frame: Baseline (Day 1) and Day 15 of each treatment period
Percentage of Chance That FF 100 mcg Alone Corrected Change From Baseline FEV1 Response Would Exceed a Target Response by Dose of UMEC Combined With FF 100 mcg
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Data is presented as percentage chance that FF 100 mcg alone corrected change from baseline trough FEV1 response would exceed a target response of 50 mL, 75 mL, 100 mL and 150 mL by doses of UMEC combined with FF 100 mcg.
Time frame: Baseline (Day 1) and Day 15 of each treatment period
Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. The highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. The change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Analysis was done using a mixed model, including treatment, period, period baseline FEV1, and mean baseline FEV1 as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Time frame: Baseline (Day 1) and Day 15 of each treatment period
Mean Change From Baseline in Daily Morning (Pre-dose and Pre-rescue Bronchodilator) Peak Expiratory Flow (PEF) of Each Treatment Period
PEF is a measure of lung function and measures how fast a person can breathe out. Morning PEF was measured pre-dose and pre- rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline morning PEF and mean baseline morning PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Time frame: Baseline (Week 0) and last 7 days of each treatment period
Mean Change From Baseline in Daily Evening (Pre-dose and Pre-rescue Bronchodilator) PEF of Each Treatment Period
PEF is a measure of lung function and measures how fast a person can breathe out. Evening PEF was measured pre-dose and pre-rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and seven days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline evening PEF and mean baseline evening PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Time frame: Baseline (Week 0) and last 7 days of each treatment period
Mean Change From Baseline in Rescue Albuterol/Salbutamol Use of Each Treatment Period.
Short-Acting Beta2-Agonists albuterol/salbutamol was provided to participants as rescue medication, to use in morning and evening. Participants recorded number of puffs of salbutamol MDI used in last 24 hours (sum of night time and day time puffs) daily for relief of symptoms in eDiary. Mean change from baseline was calculated where, baseline was defined as measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 (for night time puffs) and seven days (for day time puffs) for each treatment period. Change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and the baseline week. Analysis was done using a mixed model, including treatment, period, period baseline rescue albuterol use, and mean baseline rescue albuterol use as fixed effects and participant as random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
Time frame: Baseline (Week 0) and last 7 days of each treatment period
The study was conducted across 33 centres of 5 countries from 03 April 2012 to 04 February 2013 in adults aged 18 to 50 years with persistent asthma. Participants were randomized for 3 treatment periods of 2 weeks each.
| Milestone | FF 100 mcg First | FF 100 mcg + UMEC 15.6 mcg First | FF 100 mcg + UMEC 31.25 mcg First | FF 100 mcg + UMEC 62.5 mcg First | FF 100 mcg + UMEC 125 mcg First | FF 100 mcg + UMEC 250 mcg First | FF 100 mcg + VI 25 mcg First |
|---|---|---|---|---|---|---|---|
| Started | 64 | 62 | 60 | 63 | 58 | 55 | 59 |
| Completed | 58 | 59 | 51 | 61 | 56 | 51 | 57 |
| Not completed | 6 | 3 | 9 | 2 | 2 | 4 | 2 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 4 | 3 | 6 | 1 | 2 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 1 | 0 | 0 | 2 | 0 |
| Withdrew: Protocol-defined stopping criteria | 0 | 0 | 1 | 1 | 0 | 1 | 1 |
| Milestone | FF 100 mcg First | FF 100 mcg + UMEC 15.6 mcg First | FF 100 mcg + UMEC 31.25 mcg First | FF 100 mcg + UMEC 62.5 mcg First | FF 100 mcg + UMEC 125 mcg First | FF 100 mcg + UMEC 250 mcg First | FF 100 mcg + VI 25 mcg First |
|---|---|---|---|---|---|---|---|
| Started | 58 | 59 | 51 | 61 | 56 | 51 | 57 |
| Completed | 57 | 58 | 48 | 56 | 56 | 48 | 55 |
| Not completed | 1 | 1 | 3 | 5 | 0 | 3 | 2 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 | 0 | 1 | 0 | 0 | 1 |
| Withdrew: Protocol violation | 1 | 0 | 2 | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 2 | 0 | 0 | 1 |
| Withdrew: Protocol-defined stopping criteria | 0 | 0 | 1 | 1 | 0 | 1 | 0 |
| Milestone | FF 100 mcg First | FF 100 mcg + UMEC 15.6 mcg First | FF 100 mcg + UMEC 31.25 mcg First | FF 100 mcg + UMEC 62.5 mcg First | FF 100 mcg + UMEC 125 mcg First | FF 100 mcg + UMEC 250 mcg First | FF 100 mcg + VI 25 mcg First |
|---|---|---|---|---|---|---|---|
| Started | 57 | 58 | 48 | 56 | 56 | 48 | 55 |
| Completed | 50 | 52 | 45 | 55 | 53 | 43 | 55 |
| Not completed | 7 | 6 | 3 | 1 | 3 | 5 | 0 |
| Withdrew: Lack of efficacy | 5 | 4 | 2 | 1 | 3 | 2 | 0 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 | 0 | 2 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
| Withdrew: Protocol-defined stopping criteria | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | FF 100 mcg First | FF 100 mcg + UMEC 15.6 mcg First | FF 100 mcg + UMEC 31.25 mcg First | FF 100 mcg + UMEC 62.5 mcg First | FF 100 mcg + UMEC 125 mcg First | FF 100 mcg + UMEC 250 mcg First | FF 100 mcg + VI 25 mcg First |
|---|---|---|---|---|---|---|---|
| Started | 50 | 52 | 45 | 55 | 53 | 43 | 55 |
| Completed | 49 | 48 | 43 | 53 | 52 | 41 | 52 |
| Not completed | 1 | 4 | 2 | 2 | 1 | 2 | 3 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 | 1 | 1 | 1 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Withdrew: Protocol-defined stopping criteria | 0 | 1 | 1 | 1 | 0 | 1 | 0 |
| Milestone | FF 100 mcg First | FF 100 mcg + UMEC 15.6 mcg First | FF 100 mcg + UMEC 31.25 mcg First | FF 100 mcg + UMEC 62.5 mcg First | FF 100 mcg + UMEC 125 mcg First | FF 100 mcg + UMEC 250 mcg First | FF 100 mcg + VI 25 mcg First |
|---|---|---|---|---|---|---|---|
| Started | 49 | 48 | 43 | 53 | 52 | 41 | 52 |
| Completed | 46 | 47 | 43 | 53 | 51 | 39 | 48 |
| Not completed | 3 | 1 | 0 | 0 | 1 | 2 | 4 |
| Withdrew: Lack of efficacy | 2 | 0 | 0 | 0 | 1 | 1 | 4 |
| Withdrew: Protocol violation | 0 | 1 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | FF 100 mcg First | FF 100 mcg + UMEC 15.6 mcg First | FF 100 mcg + UMEC 31.25 mcg First | FF 100 mcg + UMEC 62.5 mcg First | FF 100 mcg + UMEC 125 mcg First | FF 100 mcg + UMEC 250 mcg First | FF 100 mcg + VI 25 mcg First |
|---|---|---|---|---|---|---|---|
| Started | 46 | 47 | 43 | 53 | 51 | 39 | 48 |
| Completed | 45 | 47 | 43 | 53 | 49 | 38 | 48 |
| Not completed | 1 | 0 | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 2 | 1 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 ante meridiem (AM) and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Slope-intercept on log dose model was used to predict trough FEV1 change from baseline for each of the FF+UMEC doses adjusted by FF 100 mcg alone. Mean value for the expected response and associated 95% confidence interval (CI) in change from baseline trough FEV1 is presented.
| Litres (L) | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg |
|---|---|---|---|---|---|
| Model Predicted Change From Baseline Trough Force Expiratory Volume in 1 Second (FEV1) | 0.0260 (-0.0098 to 0.0611) | 0.0320 (-0.0036 to 0.0679) | 0.0385 (-0.0011 to 0.0745) | 0.0444 (0.0067 to 0.0813) | 0.0510 (0.0139 to 0.0873) |
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. Highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. Change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Data is presented as percentage chance that FF 100 mcg alone corrected change from baseline trough FEV1 response would exceed a target response of 50 mL, 75 mL, 100 mL and 150 mL by doses of UMEC combined with FF 100 mcg.
| Percentage chance | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg |
|---|---|---|---|---|---|
| Target response of 50 mL | 9 | 17 | 27 | 37 | 52 |
| Target response of 75 mL | 0.5 | 1 | 2 | 5 | 10 |
| Target response of 100 mL | 0 | 0 | 0 | 0.2 | 0.2 |
| Target response of 150 mL | 0 | 0 | 0 | 0 | 0 |
FEV1 is a lung function measure defined as the maximal amount of air that can be forcefully exhaled in one second. The highest FEV1 from the 3 acceptable spirometric efforts were recorded between 5.00 AM and 11.00 AM after withholding albuterol (salbutamol) at all visits for at least 4 hours. Baseline was defined as the pre- dose FEV1 value obtained on Day 1 and trough was defined as the FEV1 value obtained 24 hours after morning dosing on Day 14 of each treatment period. The change from baseline value for each participant in each treatment period was the difference between the observed on-treatment value obtained 24 hours after morning dosing on Day 14 and the baseline value for that period. Analysis was done using a mixed model, including treatment, period, period baseline FEV1, and mean baseline FEV1 as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
| Litres (L) | FF 100 mcg | FF 100mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg | FF 100 mcg + VI 25 mcg |
|---|---|---|---|---|---|---|---|
| Mean Change From Baseline in Trough FEV1 on Day 15 of Each of the 3 Treatment Periods | 0.120 ± 0.0175 | 0.145 ± 0.0170 | 0.152 ± 0.0174 | 0.145 ± 0.0172 | 0.174 ± 0.0170 | 0.175 ± 0.0172 | 0.198 ± 0.0174 |
PEF is a measure of lung function and measures how fast a person can breathe out. Morning PEF was measured pre-dose and pre- rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline morning PEF and mean baseline morning PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
| Litres per min (L/min) | FF 100 mcg | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg | FF 100 mcg + VI 25 mcg |
|---|---|---|---|---|---|---|---|
| Mean Change From Baseline in Daily Morning (Pre-dose and Pre-rescue Bronchodilator) Peak Expiratory Flow (PEF) of Each Treatment Period | -2.9 ± 2.44 | 13.0 ± 2.44 | 14.5 ± 2.46 | 15.7 ± 2.47 | 20.0 ± 2.44 | 19.0 ± 2.44 | 24.1 ± 2.46 |
PEF is a measure of lung function and measures how fast a person can breathe out. Evening PEF was measured pre-dose and pre-rescue bronchodilator use with an electronic Peak Flow Meter. Participants were issued an electronic diary (eDiary) for daily use throughout the study and instructed on how to complete it. Best of 3 attempts were recorded in eDiary. Mean change from baseline was calculated where, baseline was defined as the measurement from (Week 0), includes Day 1 and seven days immediately preceding Day 1 for each treatment period. The change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and baseline week. Analysis was done using a mixed model, including treatment, period, period baseline evening PEF and mean baseline evening PEF as fixed effects and participant as a random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
| L/min | FF 100 mcg | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg | FF 100 mcg + VI 25 mcg |
|---|---|---|---|---|---|---|---|
| Mean Change From Baseline in Daily Evening (Pre-dose and Pre-rescue Bronchodilator) PEF of Each Treatment Period | -5.2 ± 2.51 | 11.1 ± 2.53 | 12.1 ± 2.54 | 16.0 ± 2.56 | 23.7 ± 2.52 | 17.7 ± 2.52 | 21.4 ± 2.58 |
Short-Acting Beta2-Agonists albuterol/salbutamol was provided to participants as rescue medication, to use in morning and evening. Participants recorded number of puffs of salbutamol MDI used in last 24 hours (sum of night time and day time puffs) daily for relief of symptoms in eDiary. Mean change from baseline was calculated where, baseline was defined as measurement from (Week 0), includes Day 1 and six days immediately preceding Day 1 (for night time puffs) and seven days (for day time puffs) for each treatment period. Change from baseline values for each participant in each treatment period were differences between on-treatment week (last 7 days of each treatment period) values and the baseline week. Analysis was done using a mixed model, including treatment, period, period baseline rescue albuterol use, and mean baseline rescue albuterol use as fixed effects and participant as random effect. A post hoc analysis was performed to confirm nullification of carry over effect of UMEC.
| Number of puffs | FF 100 mcg | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg | FF 100 mcg + VI 25 mcg |
|---|---|---|---|---|---|---|---|
| Mean Change From Baseline in Rescue Albuterol/Salbutamol Use of Each Treatment Period. | -0.2 ± 0.09 | -0.4 ± 0.09 | -0.4 ± 0.09 | -0.3 ± 0.09 | -0.5 ± 0.09 | -0.4 ± 0.09 | -0.6 ± 0.09 |
Collected over Adverse events (AEs) and serious adverse events (SAEs) were collected from the start of study treatment (Visit 3) up to the follow-up (Visit 12, held 7 days from the Day 15 of treatment period 3 [Visit 11]). AE's and SAE's were reported for the treatment period only ( Visit 11 [up to Day 15 of the treatment period 3]).. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| FF 100 mcg | 0/187 (0%) | 0/187 (0%) | 3/187 (1.6%) |
| FF 100 mcg + UMEC 15.6 mcg | 0/183 (0%) | 0/183 (0%) | 4/183 (2.2%) |
| FF 100 mcg + UMEC 31.25 mcg | 0/179 (0%) | 1/179 (0.6%) | 2/179 (1.1%) |
| FF 100 mcg + UMEC 62.5 mcg | 0/180 (0%) | 0/180 (0%) | 5/180 (2.8%) |
| FF 100 mcg + UMEC 125 mcg | 0/176 (0%) | 0/176 (0%) | 4/176 (2.3%) |
| FF 100 mcg + UMEC 250 mcg | 0/186 (0%) | 0/186 (0%) | 7/186 (3.8%) |
| FF 100 mcg + VI 25 mcg | 0/172 (0%) | 1/172 (0.6%) | 6/172 (3.5%) |
| Event | FF 100 mcg | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg | FF 100 mcg + VI 25 mcg |
|---|---|---|---|---|---|---|---|
| Cholecystitis acuteHepatobiliary disorders | 0/187 | 0/183 | 0/179 | 0/180 | 0/176 | 0/186 | 1/172 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/187 | 0/183 | 1/179 | 0/180 | 0/176 | 0/186 | 0/172 |
| Event | FF 100 mcg | FF 100 mcg + UMEC 15.6 mcg | FF 100 mcg + UMEC 31.25 mcg | FF 100 mcg + UMEC 62.5 mcg | FF 100 mcg + UMEC 125 mcg | FF 100 mcg + UMEC 250 mcg | FF 100 mcg + VI 25 mcg |
|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 3/187 | 4/183 | 2/179 | 5/180 | 4/176 | 7/186 | 6/172 |
| Age, Continuous(Years) | All Treatments Combined |
|---|---|
| Mean | 47.5 ± 13.84 |
| Sex: Female, Male(Participants) | All Treatments Combined |
|---|---|
| Female | 289 |
| Male | 132 |
| Race (NIH/OMB)(Participants) | All Treatments Combined |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 36 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 18 |
| White | 367 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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