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

NCT06077019 | Recruiting

• 1 other identifier: CHRON_INDAC_VIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Exercise Performance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lung function

  Through study completion, an average of 8 weeks

Other Outcomes (6)

• Airway inflammation

  Through study completion, an average of 8 weeks

• Mannitol induced bronchial hyper reactivity

  Through study completion, an average of 8 weeks

• Exercise induced bronchial hyper reactivity

  Through study completion, an average of 8 weeks

Study Arms (3)

Vilanterol

EXPERIMENTAL

Participants inhale vilanterol + fluticasone furoat

Drug: Vilanterol and Fluticasone Furoate

Indacaterol

EXPERIMENTAL

Participants inhale indacaterol + mometasone furoate

Drug: Indacaterol and Mometasone Furoate

Placebo

PLACEBO COMPARATOR

Participants inhale placebo

Drug: Placebo

Interventions

Vilanterol and Fluticasone Furoate DRUG

Participants inhale 25 µg vilanterol + fluticasone furoate daily

Vilanterol

Indacaterol and Mometasone Furoate DRUG

Participants inhale 125 µg indacaterol + mometasone furoate daily

Indacaterol

Placebo DRUG

Participants inhale placebo daily

Placebo

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-39
• Physically active \> 5 h weekly
• Maximal oxygen consumption classified as high or very high

You may not qualify if:

• 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

Sponsors & Collaborators

• Morten Hostrup, PhD: lead

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Interventions

vilanterol; fluticasone furoate; indacaterol; Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Morten Hostrup, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten Hostrup, PhD

CONTACT

+4535321595; mhostrup@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 11, 2023
• Study Start: October 3, 2023
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Deidentified data set will be shared upon reasonable request.

Locations

DK (1)