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

Morten Hostrup, PhD1 site in 1 country30 target enrollmentJanuary 15, 2024

ConditionsExercise Performance

InterventionsPlacebo Indacaterol and Mometasonefluroate (low dose)Indacaterol and Mometasonefluroate (high dose)

DrugsIndacaterol and Mometasonefluroate (low dose)Placebo Indacaterol and Mometasonefluroate (high dose)

Overview

Phase: Not Applicable
Intervention: Placebo
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 Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 15, 2024

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

Placebo

Intervention: Placebo

Indacaterol + mometasonefluroate

Intervention: Indacaterol and Mometasonefluroate (low dose)

Indacaterol + mometasonefluroate

Intervention: Indacaterol and Mometasonefluroate (high dose)

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)
Forced Expiratory Volume in 1 second (FEV1)(Through study completion, an average of 3 weeks)
Quadriceps strength(Through study completion, an average of 3 weeks)
Respiratory muscle function(Through study completion, an average of 3 weeks)