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U-LABA/ICS Effects on Exercise Performance, Vilanterol

Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06066606
Enrollment
30
Registered
2023-10-04
Start date
2023-10-03
Completion date
2026-12-01
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Performance

Brief summary

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

Interventions

DRUGVilanterol and Fluticasone Furoate (low dose)

Participants are administered 25 µg of vilanterol + fluticasone furoate

DRUGVilanterol and Fluticasone Furoate (high dose)

Participants are administered 100 µg of vilanterol + fluticasone furoate

DRUGPlacebo

Participants are administered placebo

Sponsors

Morten Hostrup, PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Power output during sprint testingThrough study completion, an average of 3 weeksPower output measured in Watts during a sprint on a bike ergometer

Secondary

MeasureTime frameDescription
Power output during time trialThrough study completion, an average of 3 weeksMean power output measured in Watts during a time trial on a bike ergometer

Other

MeasureTime frameDescription
Forced Expiratory Volume in 1 second (FEV1)Through study completion, an average of 3 weeksFEV1 measured by spirometry
Quadriceps strengthThrough study completion, an average of 3 weeksMaximal torque (Nm) achieved during isometric contraction
Respiratory muscle functionThrough study completion, an average of 3 weeksMouth inspiratory and expiratory pressures against a closed system

Countries

Denmark

Contacts

Primary ContactMorten Hostrup, PhD
mhostrup@nexs.ku.dk+4535321595

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026