This is a multicenter, randomized, double-blind, double-dummy, crossover study with two 2-week treatment periods separated by a 2-week wash-out period. Subjects will participate in up to eight study visits and have a follow up phone call approximately a week after the last clinic visit. Visits 1, 2, 3, 5 and 6 are evening visits that will be conducted between 5PM and 11PM. Visit 4 and Visit 7 are also evening visits that will begin between 5PM and 11PM and continue over a period of approximately 24 hours. Subjects will be required to attend three clinic visits during this 24-hour period. An exercise challenge (using a treadmill) will be conducted at Visit 2, Visit 3 and Visit 6 (after 23 hours of the first treatment dose in each Treatment Period); and at 12 and 23 hours post evening dose at Visits 4 and 7. Spirometry will be conducted at specified visits and prior to and after each exercise challenge. Subjects with symptomatic allergic rhinitis at Visit 1 (screening) may be treated for up to four weeks with intranasal corticosteroids followed by a repeat screening visit to determine eligibility prior to entry into the study. Eligible subjects at visit 1 will complete a 4-week single blind run-in on FP 250 microgram (mcg) twice daily (BID), followed by 2-week double-blind Treatment Period 1 on randomized treatment, a 2-week single blind washout period on FP 250 mcg BID, 2-week double-blind Treatment Period 2 receiving the alternative treatment, and follow-up contact approximately 7-days after completing Treatment Period 2. The total duration of study participation is approximately 11 weeks; and up to 15 weeks for subjects with Symptomatic Allergic Rhinitis. The primary objective of the study is to evaluate the protective effect of fluticasone furoate/vilanterol (FF/VI) 100/25 mcg once-daily compared with fluticasone propionate (FP) 250 mcg twice-daily against exercise-induced bronchoconstriction in adolescent and adult subjects aged 12 to 50 with persistent asthma. ELLIPTA, ACCUHALER, and DISKUS are registered trademarks of the GlaxoSmithKline group of companies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
75
FF/VI 100/25 mcg will be administered via ELLIPTA inhaler once daily in the evening
FP 250mcg will be administered via DISKUS inhaler, twice daily, once in the morning and once in the evening
Placebo will be administered via ELLIPTA inhaler once daily in the evening
Placebo will be administered via DISKUS / ACCUHALER, twice daily, once in the morning and once in the evening
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Huntington Beach, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
San Diego, California, United States
GSK Investigational Site
Denver, Colorado, United States
GSK Investigational Site
Tallahassee, Florida, United States
GSK Investigational Site
Savannah, Georgia, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Raleigh, North Carolina, United States
GSK Investigational Site
Medford, Oregon, United States
...and 6 more locations
Maximal Percent Decrease in Forced Expiratory Volume in One Second (FEV1) Following Exercise Challenge at 12 Hours (Hrs) Post Evening Dose From Pre-exercise FEV1.
The exercise challenge test is a stepped challenge on a treadmill. It was performed at 12 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 minutes (min) and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 12 hr post dose. ITT Population comprised of all participants randomized to treatment and who received at least one dose of study medication.
Time frame: At Week 2 of treatment period 1 and 2
Maximal Percent Decrease in FEV1 Following Exercise Challenge at 23 Hrs Post Evening Dose From Pre-exercise FEV1.
The exercise challenge test is a stepped challenge on a treadmill. It was performed at 23 hrs post evening dose at the end of the 2-week treatment period, wherein the participants exercised sufficiently to reach a heart rate between 80 to 95 percent of their predicted maximum within 4 min and maintained the heart rate with exercise for an additional 6 min followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Maximal percent decrease was calculated as pre-exercise FEV1 minus minimum post exercise FEV1 (smallest FEV1 value collected within one hr following exercise challenge) divided by pre-exercise FEV1 multiplied by 100. Pre-exercise FEV1 was defined as the FEV1 collected prior to the exercise challenge test at 23 hr post dose.
Time frame: At Week 2 of treatment period 1 and 2
Proportion of Participants With a 30 Min Post-challenge FEV1 no More Than 5 Percent Lower Than Pre-exercise FEV1 Following the Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.
The blinded treatment exercise challenge test was performed at the end of 2-weeks of treatment period 1 and treatment period 2 on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of study treatment. The challenge was followed immediately by serial assessments of FEV1 at 5, 10, 15, 30, 45 and 60 min post-exercise. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: At Week 2 of treatment period 1 and 2
Weighted Mean 0-60 Min for Percentage Decrease From Pre-exercise FEV1 Following Exercise Challenge at 12 Hrs and 23 Hrs Post Evening Dose.
The exercise challenge testing at the end of 2 week treatment period was performed on a treadmill at 12 hrs and 23 hrs after administration of the evening dose of double-blind treatment. Following exercise challenge testing, post-exercise FEV1 values were assessed serially at 5, 10, 15, 30, 45 and 60 min. Pre-exercise FEV1 was defined as the FEV1 value collected prior to the exercise challenge test at 23 hrs post-dose. Number of participants listed is the number in the ITT population. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time frame: At Week 2 of treatment period 1 and 2
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