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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01435902
• Other study ID #: 106847
• Status: Withdrawn
• Phase: Phase 3
• First received: September 15, 2011
• Last updated: June 19, 2014
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: June 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone Furoate/Vilanterol Inhalation Powder
Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks
• Fluticasone Propionate Inhalation Powder
Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal percent decrease from baseline in FEV1 following exercise challenge at 12 hours post-dose		At the end of treatment Week 4	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No