U-LABA/ICS Effects on Exercise Performance, Indacaterol

NCT ID: NCT06067100

Last Updated: 2025-04-09

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2026-12-01

Brief Summary

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

Detailed Description

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Conditions

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Exercise Performance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Indacaterol + mometasonefluroate

Group Type EXPERIMENTAL

Indacaterol and Mometasonefluroate (low dose)

Intervention Type DRUG

Participants are administered 125 µg indacaterol + mometasonefluroate

Indacaterol and Mometasonefluroate (high dose)

Intervention Type DRUG

Participants are administered 500 µg indacaterol + mometasonefluroate

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants are administered placebo

Interventions

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Indacaterol and Mometasonefluroate (low dose)

Participants are administered 125 µg indacaterol + mometasonefluroate

Intervention Type DRUG

Placebo

Participants are administered placebo

Intervention Type DRUG

Indacaterol and Mometasonefluroate (high dose)

Participants are administered 500 µg indacaterol + mometasonefluroate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Morten Hostrup, PhD

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Hostrup, PhD

Role: CONTACT

+4535321595

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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