Role of Lung Function for Exercise Capacity in Well-trained Individuals

Exercise Performance Clinical Trial

Official title:

Role of Lung Function, Airway Inflammation and Bronchial Hyper Reactivity for Exercise Capacity in Well-trained Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077019
• Other study ID #: CHRON_INDAC_VIL
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Exercise Performance

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