Effects of Vilanterol and Fluticasone on Exercise Performance
Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol
This study tests if inhaling a combination of vilanterol and fluticasone can help young, active people improve their exercise performance.
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, DK) |
| Trial ID | NCT06066606 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 vilanterol combined with fluticasone furoate. Participants will receive either a low dose, a high dose, or a placebo to assess the impact on their exercise capacity. The study focuses on individuals aged 18-39 who have a high level of maximal oxygen consumption. The goal is to determine the efficacy of this treatment in enhancing exercise performance.
Who should consider this trial
Good fit: Ideal candidates are physically active individuals aged 18-39 with 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 for patients using bronchodilators.
How similar studies have performed: Other studies have shown promising results with similar approaches, but this specific combination is being explored for the first time.
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, DK
- August Krogh Building — Copenhagen, Dk, 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.