U-LABA/ICS Effects on Exercise Performance, Indacaterol
NCT ID: NCT06067100
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-01-15
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Indacaterol + mometasonefluroate
Indacaterol and Mometasonefluroate (low dose)
Participants are administered 125 µg indacaterol + mometasonefluroate
Indacaterol and Mometasonefluroate (high dose)
Participants are administered 500 µg indacaterol + mometasonefluroate
Placebo
Placebo
Participants are administered placebo
Interventions
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Indacaterol and Mometasonefluroate (low dose)
Participants are administered 125 µg indacaterol + mometasonefluroate
Placebo
Participants are administered placebo
Indacaterol and Mometasonefluroate (high dose)
Participants are administered 500 µg indacaterol + mometasonefluroate
Eligibility Criteria
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Inclusion Criteria
* Physically active \> 5 h weekly
* Maximal oxygen consumption classified as high or very high
Exclusion Criteria
* 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
18 Years
39 Years
ALL
Yes
Sponsors
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Morten Hostrup, PhD
OTHER
Responsible Party
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Morten Hostrup, PhD
Associate Professor
Principal Investigators
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Morten Hostrup, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Copenhagen
Locations
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August Krogh Building
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Morten Hostrup, PhD
Role: primary
Other Identifiers
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INDAC
Identifier Type: -
Identifier Source: org_study_id
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