Role of Lung Function for Exercise Capacity in Well-trained Individuals

Not Applicable

Recruiting

• Conditions: Exercise Performance
• Interventions: Drug: Vilanterol and Fluticasone Furoate; Drug: Indacaterol and Mometasone Furoate; Drug: Placebo

• Registration Number: NCT06077019
• Lead Sponsor: Morten Hostrup, PhD

Brief Summary

The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study Start: 2023-10-03
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-07-15
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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
• Smoker
• Blood donation during the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vilanterol	Vilanterol and Fluticasone Furoate	Participants inhale vilanterol + fluticasone furoat
Indacaterol	Indacaterol and Mometasone Furoate	Participants inhale indacaterol + mometasone furoate
Placebo	Placebo	Participants inhale placebo

Primary Outcome Measures

Name	Time	Method
Exercise capacity during a time trial	Through study completion, an average of 8 weeks	Mean power output measured in Watts during a time trial on a bike ergometer

Secondary Outcome Measures

Name	Time	Method
Lung function	Through study completion, an average of 8 weeks	Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark