Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone Furoate (FF) | Active Comparator | 100mcg, inhaled |
|
| Fluticasone Furoate /Vilanterol (VI) | Active Comparator | 100/25mcg inhaled |
|
| Fluticasone Furoate/GSK573719 | Experimental | 100/15.6-250mcg inhaled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF/GSK573719 | Drug | 100/15.6 |
| |
| FF/GSK573719 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | St Louis | Missouri | 63141 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25452139 | Derived | Lee LA, Yang S, Kerwin E, Trivedi R, Edwards LD, Pascoe S. The effect of fluticasone furoate/umeclidinium in adult patients with asthma: a randomized, dose-ranging study. Respir Med. 2015 Jan;109(1):54-62. doi: 10.1016/j.rmed.2014.09.012. Epub 2014 Oct 2. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 115938 | Study Protocol | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
A total of 706 participants were screened for this study designed in 3 period crossover, incomplete block manner; 523 participants entered 2-week open label run-in period where they received fluticasone furoate (FF) 100 micrograms (mcg) dry powder inhalation once daily. A total of 421 participants were randomized to double-blind 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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FF 100 mcg First | Participants received a dose of FF 100 mcg via a dry powder inhaler (DPI) once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol metered-dose inhaler (MDI) was provided as the rescue medication. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 : Treatment Period 1 (14 Days) |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
100/31.25 |
|
| FF/GSK573719 | Drug | 100/62.5 |
|
| FF/GSK573719 | Drug | 100/125 |
|
| FF/GSK573719 | Drug | 100/250 |
|
| FF | Drug | 100 |
|
| FF/VI | Drug | 100/25 |
|
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. |
| Baseline (Day 1) and Day 15 of each treatment period |
| 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. | 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. | Baseline (Week 0) and last 7 days of each treatment period |
| Medford |
| Oregon |
| 97504 |
| United States |
| GSK Investigational Site | Orangeburg | South Carolina | 29118 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Buenos Aires | C1424BSF | Argentina |
| GSK Investigational Site | Buenos Aires | C1425BEN | Argentina |
| GSK Investigational Site | Buenos Aires | C1426ABP | Argentina |
| GSK Investigational Site | Mendoza | M5500CCG | Argentina |
| GSK Investigational Site | San Miguel de Tucumán | 4000 | Argentina |
| GSK Investigational Site | San Miguel de Tucumán | T4000DGF | Argentina |
| GSK Investigational Site | Puente Alto - Santiago | Región Metro de Santiago | 8207257 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500551 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 7500800 | Chile |
| GSK Investigational Site | Santiago | Región Metro de Santiago | 8880465 | Chile |
| GSK Investigational Site | Talca | Región Metro de Santiago | 3460001 | Chile |
| GSK Investigational Site | Valparaíso | Valparaiso | 2341131 | Chile |
| GSK Investigational Site | Santiago | 8380453 | Chile |
| GSK Investigational Site | Barnaul | 656038 | Russia |
| GSK Investigational Site | Kazan' | 420015 | Russia |
| GSK Investigational Site | Klin | 141600 | Russia |
| GSK Investigational Site | Moscow | 115 280 | Russia |
| GSK Investigational Site | Moscow | 123367 | Russia |
| GSK Investigational Site | Saint Petersburg | 194354 | Russia |
| GSK Investigational Site | Saint Petersburg | 194356 | Russia |
| GSK Investigational Site | Tomsk | 634001 | Russia |
| GSK Investigational Site | Tomsk | 634055 | Russia |
| GSK Investigational Site | Ufa | 450071 | Russia |
| GSK Investigational Site | Yaroslavl | 150003 | Russia |
| GSK Investigational Site | Bangkok | 10330 | Thailand |
| GSK Investigational Site | Bangkok | 10400 | Thailand |
| GSK Investigational Site | Khon Kaen | 40002 | Thailand |
| GSK Investigational Site | Nonthaburi | 11000 | Thailand |
For additional information about this study please refer to the GSK Clinical Study Register |
| 115938 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115938 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115938 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115938 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115938 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 115938 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | FF 100 mcg + UMEC 15.6 mcg First | Participants received fixed dose of FF 100 mcg and umeclidinium bromide (UMEC) 15.6 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| FG002 | FF 100 mcg + UMEC 31.25 mcg First | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| FG003 | FF 100 mcg + UMEC 62.5 mcg First | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| FG004 | FF 100 mcg + UMEC 125 mcg First | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| FG005 | FF 100 mcg + UMEC 250 mcg First | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| FG006 | FF 100 mcg + VI 25 mcg First | Participants received fixed dose of FF 100 mcg and vilanterol (VI) 25 mcg via a DPI once daily in the morning for 14 days during the first treatment period of the 3 treatment periods as per their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Period 2 : Washout Period 1 (12-14 Days) |
|
|
| Period 3 : Treatment Period 2 (14 Days) |
|
|
| Period 4 : Washout Period 2 (12-14 Days) |
|
|
| Period 5 : Treatment Period 3 (14 Days) |
|
|
| Period 6 : Follow-up Period (7 Days) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Treatments Combined | The participants received 3 of the 7 possible treatments during the 3 double blind treatment periods. Participants received study treatments in a crossover manner according to their randomization sequence. The 7 treatment regimens were, 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 and FF 100 mcg + VI 25 mcg. The study treatments were administered via a DPI taken once daily in the morning for 14 days during each study period. The treatment periods were separated by 2 washout periods of 12-14 days each. During the two week run-in period and during the two washout period, participants were administered open-label FF 100 mcg once daily in the morning via a DPI. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The primary endpoint was analyzed using Intent -to -Treat (ITT) Population defined as all participants randomized to treatment and who received at least one dose of study medication. Only those participants with data available at the indicated time points were analyzed. | Posted | Mean | 95% Confidence Interval | Litres (L) | Baseline (Day 1) and Day 15 of each treatment period |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Number | Percentage chance | Baseline (Day 1) and Day 15 of each treatment period |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Litres (L) | Baseline (Day 1) and Day 15 of each treatment period |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Litres per min (L/min) | Baseline (Week 0) and last 7 days of each treatment period |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | L/min | Baseline (Week 0) and last 7 days of each treatment period |
| ||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT Population. Only those participants with data available at the indicated time points were analyzed. | Posted | Least Squares Mean | Standard Error | Number of puffs | Baseline (Week 0) and last 7 days of each treatment period |
|
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]).
ITT Population was used.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FF 100 mcg | Participants received a dose of FF 100 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 187 | 0 | 187 | 3 | 187 |
| EG001 | FF 100 mcg + UMEC 15.6 mcg | Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 183 | 0 | 183 | 4 | 183 |
| EG002 | FF 100 mcg + UMEC 31.25 mcg | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 179 | 1 | 179 | 2 | 179 |
| EG003 | FF 100 mcg + UMEC 62.5 mcg | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 180 | 0 | 180 | 5 | 180 |
| EG004 | FF 100 mcg + UMEC 125 mcg | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 176 | 0 | 176 | 4 | 176 |
| EG005 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 186 | 0 | 186 | 7 | 186 |
| EG006 | FF 100 mcg + VI 25 mcg | Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. | 0 | 172 | 1 | 172 | 6 | 172 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedRA | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedRA | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Lack of Efficacy |
|
| Protocol Violation |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Protocol-defined stopping criteria |
|
| Protocol Violation |
|
| Physician Decision |
|
| Withdrawal by Subject |
|
| Protocol-defined stopping criteria |
|
| Lack of Efficacy |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Protocol-defined stopping criteria |
|
| Protocol Violation |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG004 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG001 | FF 100 mcg + UMEC 31.25 mcg | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG002 | FF 100 mcg + UMEC 62.5 mcg | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG003 | FF 100 mcg + UMEC 125 mcg | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG004 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
|
|
| OG001 | FF 100mcg + UMEC 15.6 mcg | Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG002 | FF 100 mcg + UMEC 31.25 mcg | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG003 | FF 100 mcg + UMEC 62.5 mcg | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG004 | FF 100 mcg + UMEC 125 mcg | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG005 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG006 | FF 100 mcg + VI 25 mcg | Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
|
|
|
| OG001 | FF 100 mcg + UMEC 15.6 mcg | Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG002 | FF 100 mcg + UMEC 31.25 mcg | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG003 | FF 100 mcg + UMEC 62.5 mcg | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG004 | FF 100 mcg + UMEC 125 mcg | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG005 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG006 | FF 100 mcg + VI 25 mcg | Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
|
|
|
| OG001 | FF 100 mcg + UMEC 15.6 mcg | Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG002 | FF 100 mcg + UMEC 31.25 mcg | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG003 | FF 100 mcg + UMEC 62.5 mcg | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG004 | FF 100 mcg + UMEC 125 mcg | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG005 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG006 | FF 100 mcg + VI 25 mcg | Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
|
|
|
| OG001 | FF 100 mcg + UMEC 15.6 mcg | Participants received fixed dose of FF 100 mcg and UMEC 15.6 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG002 | FF 100 mcg + UMEC 31.25 mcg | Participants received fixed dose of FF 100 mcg and UMEC 31.25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG003 | FF 100 mcg + UMEC 62.5 mcg | Participants received fixed dose of FF 100 mcg and UMEC 62.5 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG004 | FF 100 mcg + UMEC 125 mcg | Participants received fixed dose of FF 100 mcg and UMEC 125 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG005 | FF 100 mcg + UMEC 250 mcg | Participants received fixed dose of FF 100 mcg and UMEC 250 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
| OG006 | FF 100 mcg + VI 25 mcg | Participants received fixed dose of FF 100 mcg and VI 25 mcg via a DPI once daily in the morning for 14 days in any one of the 3 treatment periods according to their randomization sequence. The 3 treatment periods were separated by 2 washout periods of 12-14 days each. Participants were administered with open-label FF 100 mcg once daily in the morning via a DPI while on washout period. Participants were followed-up for 7 days post-treatment. Salbutamol MDI was provided as the rescue medication. |
|
|
|