U-LABA/ICS Effects on Exercise Performance, Formoterol

Morten Hostrup, PhD

Status: Completed

Conditions: Exercise Performance

Treatments: Drug: Placebo; Drug: Symbicort; Drug: Formoterol; Drug: Mannitol

Study type: Interventional

Funder types: Other

Identifiers

NCT06105671

FOR

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 5 patient groups, including a placebo group

Symbicort - usual care

Experimental group

Description:

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

Treatment:

Drug: Symbicort

Formoterol - inhalation

Experimental group

Description:

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

Treatment:

Drug: Formoterol

Drug: Formoterol

Formoterol - oral

Experimental group

Description:

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

Treatment:

Drug: Formoterol

Drug: Formoterol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Mannitol-test

Experimental group

Description:

Participants are administered Bronchitol from an inhaler device testing.

Treatment:

Drug: Mannitol