Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
All Genders
Healthy Volunteers
ID06077019

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

Led by Morten Hostrup, PhD · Updated on 2025-04-09

60

Participants Needed

1

Research Sites

19 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates how lung function, airway inflammation, and bronchial hyperreactivity affect exercise capacity in well-trained individuals aged 18 to 39. The study evaluates exercise performance after prolonged inhalation of beta2-agonists combined with corticosteroids, specifically vilanterol with fluticasone furoate and indacaterol with mometasone furoate. The goal is to understand how these treatments influence exercise capacity and lung function in healthy, physically active people who have high or very high maximal oxygen consumption. Participants are randomly assigned to inhale one of three treatments daily: vilanterol plus fluticasone furoate, indacaterol plus mometasone furoate, or a placebo. Each treatment is inhaled once per day over an average period of eight weeks. This quadruple-masked study compares the effects of the two active drug combinations to placebo to assess their impact on exercise performance. During the study, participants will perform exercise time trials to measure their exercise capacity, which is the primary outcome. Lung function tests are also conducted regularly as a secondary outcome. The study involves monitoring participants' physical activity and lung health while tracking inhalation adherence. The total participation duration is about eight weeks, during which researchers assess changes in exercise ability and respiratory function under the different treatment conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 39Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-39 years
  • Physically active more than 5 hours weekly
  • Maximal oxygen consumption classified as high or very high
Not Eligible

You will not qualify if you...

  • Diagnosed with severe asthma and treated with long-acting beta2-agonist/corticosteroid
  • ECG abnormality
  • ACQ score greater than 1.5
  • Severe bronchial hyperreactivity determined by mannitol test
  • FEV1/FVC ratio less than 0.7 by spirometry
  • Chronic illness posing potential risk during study
  • Chronic treatment with medication that may interfere with study results
  • Pregnancy
  • Smoker
  • Blood donation within the past 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 8 weeks

Participants inhale one of the study drugs or placebo daily to assess lung function and exercise capacity.

Weekly visits for up to 8 weeks

Trial Site Locations

Total: 1 location

1

August Krogh Building

Copenhagen, Denmark, 2100

Actively Recruiting

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Research Team

M

Morten Hostrup, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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