U-LABA/ICS Effects on Exercise Performance, Vilanterol

Morten Hostrup, PhD

Status: Enrolling

Conditions: Exercise Performance

Treatments: Drug: Vilanterol and Fluticasone Furoate (low dose); Drug: Placebo; Drug: Vilanterol and Fluticasone Furoate (high dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT06066606

VIL

Details and patient eligibility

About

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

Enrollment: 30 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: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Vilanterol + fluticasone furoate

Experimental group

Description:

Participants are administered Vilanterol + fluticasone furoate from an inhaler device testing

Treatment:

Drug: Vilanterol and Fluticasone Furoate (high dose)

Drug: Vilanterol and Fluticasone Furoate (low dose)

Placebo

Placebo Comparator group

Description:

Participants are administered placebo from an inhaler device testing

Treatment:

Drug: Placebo