A Study of a New Asthma Medicine in Asthmatics Whose Asthma Worsens With Exercise

A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice Daily in Asthmatic Adolescent and Adult Subjects With Exercise-Induced Bronchoconstriction

The primary objective of this study is to demonstrate that the combination of inhaled fluticasone furoate/vilanterol (100 mcg/25 mcg) once daily provides superior protection throughout the day against bronchoconstriction induced by exercise compared with fluticasone propionate 250 mcg twice daily in adolescent and adult subjects aged 12 to 50 diagnosed with persistent asthma.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Drug: Fluticasone Furoate/Vilanterol Inhalation Powder; Drug: Fluticasone Propionate Inhalation Powder

• Study Type: Interventional
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatient male or female 12 to 50 years of age
• Females of child-bearing potential must be willing to use birth control or commit to abstinence during the study
• Diagnosis of persistent asthma for at least 6 months
• Best pre-bronchodilator FEV1 of at least 70%.
• Current use of a low- to moderate-dose inhaled corticosteroid
• Ability to withhold albuterol 6 hours prior to visits.
• Physically able to perform exercise testing on a treadmill when albuterol has been withheld

Exclusion Criteria:

• Intermittent asthma, seasonal asthma, or exercise-induced asthma only
• Symptomatic allergic rhinitis and/or thrush
• Abnormal, clinically significant electrocardigraph
• Respiratory infection within 4 weeks of first visit leading to asthma medication change or could affect subjects's asthma status or participation
• Asthma exacerbation within 12 weeks of first visit
• Respiratory diseases or other concurrent disease that would put subject at risk or confound results interpretation
• Investigational medicines within 30 days of first visit or less than five half-lives of medication in prior study
• Allergy to study drugs or study drug excipients
• Concomitant medications that could interact with study medications or affect the course of asthma
• Tobacco use within last year and/or a 10 pack-years history
• Inability to comply with requirements of the study
• Affiliation with investigator's site (example: family member)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fluticasone Furoate/Vilanterol; Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks	Drug: Fluticasone Furoate/Vilanterol Inhalation Powder; Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks
Active Comparator: Fluticasone Propionate; Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks	Drug: Fluticasone Propionate Inhalation Powder; Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose	At the end of treatment Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose	At the end of treatment Week 4
Time required for recovery to within 5% of the pre-exercise baseline FEV1 from the time of the maximal percentage decrease from baseline following the challenge at 1 hour, 12 hours, and 23 hours post-dose	At the end of treatment Week 4
AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose	At the end of treatment Week 4
Evaluation of a categorical treatment response using the percentage of subjects who demonstrate a decrease from the pre-exercise baseline in FEV1 of 1) <10%, 2) 10 to <20%, and 3) =/>20%.	At the end of treatment Week 4
Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose.	At the end of treatment Week 4

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: September 15, 2011
• First Submitted That Met QC Criteria: September 16, 2011
• First Posted (Estimate): September 19, 2011

Study Record Updates

• Last Update Posted (Estimate): June 23, 2014
• Last Update Submitted That Met QC Criteria: June 19, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: asthma; exercise-induced bronchospasm; Activity/Exercise induced bronchospasm
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Fluticasone; Xhance
• Other Study ID Numbers: 106847