Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06077019

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Exercise Performance

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Morten Hostrup, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vilanterol and Fluticasone Furoate

Drug

Participants inhale 25 µg vilanterol + fluticasone furoate daily

Indacaterol and Mometasone Furoate

Drug

Participants inhale 125 µg indacaterol + mometasone furoate daily

Placebo

Drug

Participants inhale placebo daily

Primary outcomes

  1. Exercise capacity during a time trial

    Time frame: Through study completion, an average of 8 weeks

    Mean power output measured in Watts during a time trial on a bike ergometer

Secondary outcomes

  1. Lung function

    Time frame: 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

Other outcomes

  1. Airway inflammation

    Time frame: Through study completion, an average of 8 weeks

    Measured by fractional nitric oxide in expired air

  2. Mannitol induced bronchial hyper reactivity

    Time frame: Through study completion, an average of 8 weeks

    Assessed by decreases in FEV1 as dose response to cumulative doses of mannitol

  3. Exercise induced bronchial hyper reactivity

    Time frame: Through study completion, an average of 8 weeks

    Assessed by decreases in FEV1 after maximal exercise

  4. Quadriceps muscle strength

    Time frame: Through study completion, an average of 8 weeks

    Assessed by maximal isometric contraction torque

  5. Lean body mass

    Time frame: Through study completion, an average of 8 weeks

    Measured with DXA-scanning

  6. Fat mass

    Time frame: Through study completion, an average of 8 weeks

    Measured with DXA-scanning

Study contacts

Contact information is provided by the study sponsor or research team.

Morten Hostrup, PhD

CONTACT

[email protected]

+4535321595

Sponsors and collaborators

Lead sponsor

Morten Hostrup, PhD

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.