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Clinical Trials/NCT06105671
NCT06105671
Completed
Not Applicable

Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol

Morten Hostrup, PhD1 site in 1 country20 target enrollmentJanuary 5, 2024

Overview

Phase
Not Applicable
Intervention
Symbicort
Conditions
Exercise Performance
Sponsor
Morten Hostrup, PhD
Enrollment
20
Locations
1
Primary Endpoint
Power output during time trial
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.

Registry
clinicaltrials.gov
Start Date
January 5, 2024
End Date
July 4, 2024
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 18-45
  • Physically active \>5 hours a week
  • Maximum oxygen uptake classified as high or very high

Exclusion Criteria

  • Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
  • ECG abnormality
  • FEV1/FVC ratio \< 0,7 determined with spirometry
  • Chronic illness determined to be a potential risk for participant during the study
  • In chronic treatments with medication that may interfere with study results
  • Pregnancy
  • Blood donation during the past 3 months

Arms & Interventions

Symbicort - usual care

Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.

Intervention: Symbicort

Formoterol - inhalation

Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.

Intervention: Formoterol

Formoterol - oral

Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.

Intervention: Formoterol

Placebo

Participants are administered placebo from an inhaler device testing and a placebo capsule.

Intervention: Placebo

Mannitol-test

Participants are administered Bronchitol from an inhaler device testing.

Intervention: Mannitol

Outcomes

Primary Outcomes

Power output during time trial

Time Frame: Through study completion, an average on 4 weeks

Mean power output measured in Watts during a time trial on a bike ergometer

Secondary Outcomes

  • Power output during sprint testing(Through study completion, an average on 4 weeks)

Study Sites (1)

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