CompletedPhase 4

Crossover Study Comparing Fluticasone Furoate (FF)/Vilanterol (VI) Once Daily Versus Fluticasone Propionate (FP) Twice Daily in Subjects With Asthma and Exercise-Induced Bronchoconstriction (EIB)

United States75 participantsStarted 2016-05-25

Plain-language summary

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.

Who can participate

Age range12 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Informed consent: Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities. * Age Range: 12 to 50 years of age, inclusive, at Visit 1 (Screening). * Diagnosis: A diagnosis of asthma, as defined by the National Institutes of Health for at least 12 weeks prior to Visit 1. * Asthma Severity: Subjects must have a pre-bronchodilator FEV1 of \>=70 percent of the predicted normal value. Predicted values will be based upon Global Lung Function Initiative equations for spirometry reference values. * Evidence of EIB: Subjects must answer "Yes" to at least 2 of the following 3 questions reflecting on the previous 12 months: * Are you short of breath during exercise or other physical exertion? * Do you wheeze after exercise or other physical exertion? * Do you cough after exercise or other physical exertion? * Concurrent Anti-Asthma Therapy: Subjects must be taking low- to moderate dose inhaled steroids for 12 weeks prior to Visit 1 in order to participate with no change in dose for the 4 weeks prior to Visit 1. * Gender: Subjects may be male or an eligible female. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile).Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophore…

What they're measuring

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.

Timeframe: At Week 2 of treatment period 1 and 2

Trial details

NCT IDNCT02730351

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02-03

Results submitted2017-07-28