Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Power output during sprint testing
Study Overview
Brief Summary
The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age 18-39
- •Physically active > 5 h weekly
- •Maximal oxygen consumption classified as high or very high
Exclusion Criteria
- •Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
- •ECG abnormality
- •ACQ score > 1.5
- •Severe bronchial hyperreactivity as determined by mannitol test
- •FEV1/FVC ratio < 0.7 determined with spirometry
- •Chronic illness determined to be a potential risk for participant during study
- •In chronic treatment with medication that may interfere with study results
- •Pregnancy
- •Blood donation during the past 3 months
Arms & Interventions
Vilanterol + fluticasone furoate
Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing
Intervention: Vilanterol and Fluticasone Furoate (low dose) (Drug)
Vilanterol + fluticasone furoate
Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing
Intervention: Vilanterol and Fluticasone Furoate (high dose) (Drug)
Placebo
Participants are administered placebo from an inhaler device testing
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Power output during sprint testing
Time Frame: Through study completion, an average of 3 weeks
Power output measured in Watts during a sprint on a bike ergometer
Secondary Outcomes
- Power output during time trial(Through study completion, an average of 3 weeks)
Investigators
Morten Hostrup, PhD
Associate Professor
University of Copenhagen