Effects of Indacaterol and Mometasone on Exercise Performance
Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Indacaterol
This study is testing if inhaling a combination of two medications can help active young adults perform better during exercise.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06067100 on ClinicalTrials.gov |
What this trial studies
This project investigates how exercise performance in physically active individuals is affected by the acute inhalation of the beta2-agonist indacaterol combined with mometasone furoate. Participants will receive either a low dose, high dose, or placebo to assess the impact on their exercise capacity. The study focuses on individuals aged 18-39 with high levels of physical activity and maximal oxygen consumption. The goal is to determine the efficacy of these medications in enhancing exercise performance.
Who should consider this trial
Good fit: Ideal candidates are physically active individuals aged 18-39 with high or very high maximal oxygen consumption.
Not a fit: Patients with severe asthma or those on chronic treatment with long-acting beta2-agonists or corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise performance in individuals using bronchodilators for respiratory conditions.
How similar studies have performed: Other studies have shown positive outcomes with similar approaches in enhancing exercise performance through bronchodilation.
Eligibility criteria
Show full inclusion / exclusion 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 * Smoker * Blood donation during the past 3 months
Where this trial is running
Copenhagen
- August Krogh Building — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Morten Hostrup, PhD — University of Copenhagen
- Study coordinator: Morten Hostrup, PhD
- Email: mhostrup@nexs.ku.dk
- Phone: +4535321595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.