CClinicalTrials.gg
CompletedNCT06105671Updated Aug 13, 2024

U-LABA/ICS Effects on Exercise Performance, Formoterol

An interventional study of Symbicort and Formoterol in Exercise Performance, sponsored by Morten Hostrup, PhD. Completed at 1 site in Denmark. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-13.

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

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

The purpose of the project is to investigate exercise performance in well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.

02

Conditions studied

  • Exercise Performance
03

In context

Lead sponsor

Morten Hostrup, PhD is the lead sponsor of 14 studies on the registry; 5 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 18-45
  • Physically active >5 hours a week
  • Maximum oxygen uptake classified as high or very high

Exclusion criteria

Exclusion Criteria:

  • Diagnosed with severe asthma and been in treatment with long-acting beta2-agonist/corticosteroid
  • ECG abnormality
  • FEV1/FVC ratio \< 0,7 determined with spirometry
  • Chronic illness determined to be a potential risk for participant during the study
  • In chronic treatments with medication that may interfere with study results
  • Pregnancy
  • Smoker
  • Blood donation during the past 3 months
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
20 participants (actual)

Study arms

  • Experimental
    Symbicort - usual care

    Participants are administered Formoterol + Budesonide from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.

    Drug: Symbicort

  • Experimental
    Formoterol - inhalation

    Participants are administered Formoterol from an inhaler device testing. In addition, participants are administered a placebo capsule, which is taken orally.

    Drug: Formoterol

  • Experimental
    Formoterol - oral

    Participants are administered a Formoterol capsule, which is taken orally. In addition, participants are administered placebo from an inhaler device.

    Drug: Formoterol

  • Placebo comparator
    Placebo

    Participants are administered placebo from an inhaler device testing and a placebo capsule.

    Drug: Placebo

  • Experimental
    Mannitol-test

    Participants are administered Bronchitol from an inhaler device testing.

    Drug: Mannitol

Interventions

  • DrugSymbicort

    Participants are administered 54 μg Formoterol and 1920 μg Budesonide

  • DrugFormoterol

    Participants are administered 54 μg Formoterol from an inhaler device

  • DrugFormoterol

    Participants are administered 120 μg Formoterol in a capsule, which is taken orally

  • DrugPlacebo

    Participants are administered placebo

  • DrugMannitol

    Participants are administered 600 mg Bronchitol

06

What researchers measure

Primary 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 on 4 weeks

Secondary 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 on 4 weeks

Other outcomes

  1. Quadriceps strength

    Maksimal torque (Nm) achieved during isometric contraction

    Time frame: Through study completion, an average on 4 weeks

  2. Forced Expiratory Volume in 1 second (FEV1)

    FEV1 measured by spirometry

    Time frame: Through study completion, an average on 4 weeks

  3. Respiratory muscle function

    Mouth inspiratory and expiratory pressures against a closed system

    Time frame: Through study completion, an average on 4 weeks

07

Study locations

1 site
  • August Krogh Building
    Copenhagen, 2100, Denmark
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06105671
Lead sponsor
Morten Hostrup, PhD
Responsible party
Morten Hostrup, PhD (Associate Professor, University of Copenhagen) — Sponsor-investigator
First posted
Oct 30, 2023
Start date
Jan 5, 2024
Primary completion
Jul 4, 2024
Completion
Jul 4, 2024
Last update
Aug 13, 2024

Study contacts

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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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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