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

NCT01435902 | Withdrawn Phase 3

• 1 other identifier: 106847
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Keywords

exercise-induced bronchospasm; Activity/Exercise induced bronchospasm; asthma

Outcome Measures

Primary Outcomes (1)

• Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose

  At the end of treatment Week 4

Secondary Outcomes (5)

• 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

Study Arms (2)

Fluticasone Furoate/Vilanterol

ACTIVE COMPARATOR

Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 4 weeks

Drug: Fluticasone Furoate/Vilanterol Inhalation Powder

Fluticasone Propionate

ACTIVE COMPARATOR

Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 4 weeks

Drug: Fluticasone Propionate Inhalation Powder

Interventions

Fluticasone Furoate/Vilanterol Inhalation Powder DRUG

Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks

Fluticasone Furoate/Vilanterol

Fluticasone Propionate Inhalation Powder DRUG

Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks

Fluticasone Propionate

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma; Asthma, Exercise-Induced; Motor Activity

Interventions

fluticasone furoate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Exercise-Induced Allergies; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 19, 2011
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: June 23, 2014

Record last verified: 2014-06