Role of Lung Function for Exercise Capacity in Well-trained Individuals

Morten Hostrup, PhD

Status: Enrolling

Conditions: Exercise Performance

Treatments: Drug: Vilanterol and Fluticasone Furoate; Drug: Indacaterol and Mometasone Furoate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06077019

CHRON_INDAC_VIL

Details and patient eligibility

About

The purpose of the project is to investigate exercise performance in humans following prolonged inhalation of beta2-agonists vilanterol + fluticasone furoate or indacaterol + mometasone furoate

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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
• Smoker
• Blood donation during the past 3 months

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Vilanterol

Experimental group

Description:

Participants inhale vilanterol + fluticasone furoat

Treatment:

Drug: Vilanterol and Fluticasone Furoate

Indacaterol

Experimental group

Description:

Participants inhale indacaterol + mometasone furoate

Treatment:

Drug: Indacaterol and Mometasone Furoate

Placebo

Placebo Comparator group

Description:

Participants inhale placebo

Treatment:

Drug: Placebo