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RecruitingNCT06066606Updated Apr 10, 2025

U-LABA/ICS Effects on Exercise Performance, Vilanterol

An interventional study of Vilanterol and Fluticasone Furoate (low dose) and Vilanterol and Fluticasone Furoate (high dose) in Exercise Performance, sponsored by Morten Hostrup, PhD. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-10.

Sponsored by Morten Hostrup, PhD · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
All
01

Study 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

02

Conditions studied

  • Exercise Performance
03

In context

Lead sponsor

Morten Hostrup, PhD is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18-39
  • Physically active > 5 h weekly
  • Maximal oxygen consumption classified as high or very high

Exclusion criteria

Exclusion Criteria:

  • Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/
  • abnormality
  • ACQ score > 1.5
  • Severe bronchial hyperreactivity as determined by mannitol test
  • /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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Vilanterol + fluticasone furoate

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

    Drug: Vilanterol and Fluticasone Furoate (low dose) · Drug: Vilanterol and Fluticasone Furoate (high dose)

  • Placebo comparator
    Placebo

    Participants are administered placebo from an inhaler device testing

    Drug: Placebo

Interventions

  • DrugVilanterol and Fluticasone Furoate (low dose)

    Drug pages: Vilanterol · Fluticasone furoate

    Participants are administered 25 µg of vilanterol + fluticasone furoate

  • DrugVilanterol and Fluticasone Furoate (high dose)

    Drug pages: Vilanterol · Fluticasone furoate

    Participants are administered 100 µg of vilanterol + fluticasone furoate

  • DrugPlacebo

    Participants are administered placebo

06

What researchers measure

Primary outcomes

  1. Power output during sprint testing

    Power output measured in Watts during a sprint on a bike ergometer

    Time frame: Through study completion, an average of 3 weeks

Secondary outcomes

  1. Power output during time trial

    Mean power output measured in Watts during a time trial on a bike ergometer

    Time frame: Through study completion, an average of 3 weeks

Other outcomes

  1. Forced Expiratory Volume in 1 second (FEV1)

    FEV1 measured by spirometry

    Time frame: Through study completion, an average of 3 weeks

  2. Quadriceps strength

    Maximal torque (Nm) achieved during isometric contraction

    Time frame: Through study completion, an average of 3 weeks

  3. Respiratory muscle function

    Mouth inspiratory and expiratory pressures against a closed system

    Time frame: Through study completion, an average of 3 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2023 (actual). Primary completion is estimated for Jul 2026, 33 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2023
First posted
Oct 4, 2023
StartActual
Oct 3, 2023
Primary completionEst.
Jul 15, 2026
CompletionEst.
Dec 1, 2026
Last update
Apr 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06066606
Lead sponsor
Morten Hostrup, PhD
Responsible party
Morten Hostrup, PhD (Associate Professor, University of Copenhagen) — Sponsor-investigator
First posted
Oct 4, 2023
Start date
Oct 3, 2023
Primary completion
Jul 15, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Apr 10, 2025

Study contacts

Morten Hostrup, PhD
Contact
mhostrup@nexs.ku.dk
+4535321595
Morten Hostrup, PhD
principal investigator · University of Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Vilanterol · Fluticasone furoate

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Morten Hostrup, PhD

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