Recruiting NCT06077019
Role of Lung Function for Exercise Capacity in Well-trained Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vilanterol and Fluticasone Furoate, Indacaterol and Mometasone Furoate, Placebo.
- Who it may be relevant to
- Registry conditions: Exercise Performance. Basic parameters: 18 years — 39 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals
Overview
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
Interventions
- Drug Vilanterol and Fluticasone Furoate
Participants inhale 25 µg vilanterol + fluticasone furoate daily - Drug Indacaterol and Mometasone Furoate
Participants inhale 125 µg indacaterol + mometasone furoate daily - Drug Placebo
Participants inhale placebo daily
Primary outcome measures
- Exercise capacity during a time trial [Time frame: Through study completion, an average of 8 weeks]
Secondary outcome measures (1)
- Lung function [Time frame: Through study completion, an average of 8 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- August Krogh Building — Copenhagen
Identifiers
NCT: NCT06077019 · CHRON_INDAC_VIL