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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06077019
Other study ID # CHRON_INDAC_VIL
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 5, 2023
Est. completion date December 1, 2025

Study information

Verified date October 2023
Source University of Copenhagen
Contact Morten Hostrup, PhD
Phone +4535321595
Email mhostrup@nexs.ku.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 1, 2025
Est. primary completion date September 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 39 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vilanterol and Fluticasone Furoate
Participants inhale 25 µg vilanterol + fluticasone furoate daily
Indacaterol and Mometasone Furoate
Participants inhale 125 µg indacaterol + mometasone furoate daily
Placebo
Participants inhale placebo daily

Locations

Country Name City State
Denmark August Krogh Building Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Morten Hostrup, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Airway inflammation Measured by fractional nitric oxide in expired air Through study completion, an average of 8 weeks
Other Mannitol induced bronchial hyper reactivity Assessed by decreases in FEV1 as dose response to cumulative doses of mannitol Through study completion, an average of 8 weeks
Other Exercise induced bronchial hyper reactivity Assessed by decreases in FEV1 after maximal exercise Through study completion, an average of 8 weeks
Other Quadriceps muscle strength Assessed by maximal isometric contraction torque Through study completion, an average of 8 weeks
Other Lean body mass Measured with DXA-scanning Through study completion, an average of 8 weeks
Other Fat mass Measured with DXA-scanning Through study completion, an average of 8 weeks
Primary Exercise capacity during a time trial Mean power output measured in Watts during a time trial on a bike ergometer Through study completion, an average of 8 weeks
Secondary Lung function Forced expiratory volume in 1 second (FEV1) measured by spirometry before and after time trial with and without beta2-agonist induced bronchodilation Through study completion, an average of 8 weeks
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