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Clinical Trials/NCT06066606
NCT06066606
Recruiting
Not Applicable

Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol

Morten Hostrup, PhD1 site in 1 country30 target enrollmentOctober 3, 2023

Overview

Phase
Not Applicable
Intervention
Vilanterol and Fluticasone Furoate (low dose)
Conditions
Exercise Performance
Sponsor
Morten Hostrup, PhD
Enrollment
30
Locations
1
Primary Endpoint
Power output during sprint testing
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of the project is to investigate exercise performance in humans following bronchodilation induced by acute inhalation of beta2-agonist vilanterol + fluticasone furoate

Registry
clinicaltrials.gov
Start Date
October 3, 2023
End Date
December 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Morten Hostrup, PhD
Responsible Party
Sponsor Investigator
Principal Investigator

Morten Hostrup, PhD

Associate Professor

University of Copenhagen

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
  • Blood donation during the past 3 months

Arms & Interventions

Vilanterol + fluticasone furoate

Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing

Intervention: Vilanterol and Fluticasone Furoate (low dose)

Vilanterol + fluticasone furoate

Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing

Intervention: Vilanterol and Fluticasone Furoate (high dose)

Placebo

Participants are administered placebo from an inhaler device testing

Intervention: Placebo

Outcomes

Primary Outcomes

Power output during sprint testing

Time Frame: Through study completion, an average of 3 weeks

Power output measured in Watts during a sprint on a bike ergometer

Secondary Outcomes

  • Power output during time trial(Through study completion, an average of 3 weeks)

Study Sites (1)

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