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U-LABA/ICS Effects on Exercise Performance, Vilanterol

M

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

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

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

Trial contacts and locations

1

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Central trial contact

Morten Hostrup, PhD

Data sourced from clinicaltrials.gov

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