U-LABA/ICS Effects on Exercise Performance, Vilanterol
Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Vilanterol
1 other identifier
interventional
30
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2023
CompletedStudy Start
First participant enrolled
October 3, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 10, 2025
April 1, 2025
2.8 years
September 20, 2023
April 7, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Power output during sprint testing
Power output measured in Watts during a sprint on a bike ergometer
Through study completion, an average of 3 weeks
Secondary Outcomes (1)
Power output during time trial
Through study completion, an average of 3 weeks
Other Outcomes (3)
Forced Expiratory Volume in 1 second (FEV1)
Through study completion, an average of 3 weeks
Quadriceps strength
Through study completion, an average of 3 weeks
Respiratory muscle function
Through study completion, an average of 3 weeks
Study Arms (2)
Vilanterol + fluticasone furoate
EXPERIMENTALParticipants are administered Vilanterol + fluticasone furoate from an inhaler device testing
Placebo
PLACEBO COMPARATORParticipants are administered placebo from an inhaler device testing
Interventions
Participants are administered 25 µg of vilanterol + fluticasone furoate
Participants are administered 100 µg of vilanterol + fluticasone furoate
Eligibility Criteria
You may qualify if:
- Age 18-39
- Physically active \> 5 h weekly
- Maximal oxygen consumption classified as high or very high
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
August Krogh Building
Copenhagen, DK, 2100, Denmark
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Morten Hostrup, PhD
University of Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 20, 2023
First Posted
October 4, 2023
Study Start
October 3, 2023
Primary Completion (Estimated)
July 15, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 10, 2025
Record last verified: 2025-04