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

This study has been withdrawn prior to enrollment.
(No participants enrolled.)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435902
First received: September 15, 2011
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Activity/Exercise Induced Bronchospasm
 Drug: Fluticasone Furoate/Vilanterol Inhalation Powder
Drug: Fluticasone Propionate Inhalation Powder
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximal percent decrease from baseline in FEV1 following exercise challenge at 1 hour and 23 hours post-dose [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]
  • AUC (0-60 minutes) for percentage decrease from baseline in FEV1 after exercise at 1 hour, 12 hours, and 23 hours post-dose [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]
  • 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%. [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]
  • Maximal percent decrease from pre-randomized treatment baseline in FEV1 following exercise challenge at 1 hour, 12 hours, and 23 hours post-dose. [ Time Frame: At the end of treatment Week 4 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435902

Locations
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
GSK Investigational Site
Denver, Colorado, United States, 80230
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Nebraska
GSK Investigational Site
Bellevue, Nebraska, United States, 68123-4303
GSK Investigational Site
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01435902     History of Changes
Other Study ID Numbers: 106847
Study First Received: September 15, 2011
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
exercise-induced bronchospasm
asthma

Additional relevant MeSH terms:
Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 22, 2013