U-LABA/ICS Effects on Exercise Performance, Formoterol

Not Applicable

Completed

• Conditions: Exercise Performance
• Interventions: Drug: Formoterol; Drug: Placebo; Drug: Symbicort; Drug: Mannitol

• Registration Number: NCT06105671
• Lead Sponsor: Morten Hostrup, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-10-23
• Study First Submitted QC: 2023-10-23
• Study First Posted: 2023-10-30
• Study Start: 2024-01-05
• Primary Completion: 2024-07-04
• Study Completion: 2024-07-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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
• Smoker
• Blood donation during the past 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Formoterol - oral	Formoterol	Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.
Placebo	Placebo	Participants are administered placebo from an inhaler device testing and a placebo capsule.
Symbicort - usual care	Symbicort	Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.
Formoterol - inhalation	Formoterol	Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.
Mannitol-test	Mannitol	Participants are administered Bronchitol from an inhaler device testing.

Primary Outcome Measures

Name	Time	Method
Power output during time trial	Through study completion, an average on 4 weeks	Mean power output measured in Watts during a time trial on a bike ergometer

Secondary Outcome Measures

Name	Time	Method
Power output during sprint testing	Through study completion, an average on 4 weeks	Power output measured in Watts during a sprint on a bike ergometer

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark