U-LABA/ICS Effects on Exercise Performance, Indacaterol

Last updated: April 7, 2025
Sponsor: Morten Hostrup, PhD
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Placebo

Indacaterol and Mometasonefluroate (low dose)

Indacaterol and Mometasonefluroate (high dose)

Clinical Study ID

NCT06067100
INDAC
  • Ages 18-39
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist indacaterol + mometasonefuroate

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-39

  • Physically active > 5 h weekly

  • Maximal oxygen consumption classified as high or very high

Exclusion

Exclusion Criteria:

  • Diagnosed with severe asthma and been in treatment with long-actingbeta2-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

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: Placebo
Phase:
Study Start date:
January 15, 2024
Estimated Completion Date:
December 01, 2026

Connect with a study center

  • August Krogh Building

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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