Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals

Morten Hostrup, PhD1 site in 1 country60 target enrollmentOctober 3, 2023

ConditionsExercise Performance

InterventionsVilanterol and Fluticasone Furoate Indacaterol and Mometasone Furoate Placebo

DrugsVilanterol and Fluticasone Furoate Indacaterol and Mometasone Furoate Placebo

Overview

Phase: Not Applicable
Intervention: Vilanterol and Fluticasone Furoate
Conditions: Exercise Performance
Sponsor: Morten Hostrup, PhD
Enrollment: 60
Locations: 1
Primary Endpoint: Exercise capacity during a time trial
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 3, 2023

End Date

December 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Morten Hostrup, PhD

Responsible Party

Sponsor Investigator

Principal Investigator

Morten Hostrup, PhD

Associate Professor

University of Copenhagen

Eligibility Criteria

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