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

This study has been withdrawn prior to enrollment.
(Study was cancelled prior to enrolling any subjects)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01435902
First received: September 15, 2011
Last updated: June 19, 2014
Last verified: June 2014
  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
Asthma
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:


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: January 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435902

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01435902     History of Changes
Other Study ID Numbers: 106847
Study First Received: September 15, 2011
Last Updated: June 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
exercise-induced bronchospasm
Activity/Exercise induced bronchospasm
asthma

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

ClinicalTrials.gov processed this record on October 29, 2014