U-LABA/ICS Effects on Exercise Performance, Formoterol

NCT ID: NCT06105671

Last Updated: 2024-08-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-05

Study Completion Date

2024-07-04

Brief Summary

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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.

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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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.

Group Type EXPERIMENTAL

Symbicort

Intervention Type DRUG

Participants are administered 54 μg Formoterol and 1920 μg Budesonide

Formoterol - inhalation

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

Participants are administered 54 μg Formoterol from an inhaler device

Formoterol - oral

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

Group Type EXPERIMENTAL

Formoterol

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants are administered placebo

Mannitol-test

Participants are administered Bronchitol from an inhaler device testing.

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

Participants are administered 600 mg Bronchitol

Interventions

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Symbicort

Participants are administered 54 μg Formoterol and 1920 μg Budesonide

Intervention Type DRUG

Formoterol

Participants are administered 54 μg Formoterol from an inhaler device

Intervention Type DRUG

Formoterol

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

Intervention Type DRUG

Placebo

Participants are administered placebo

Intervention Type DRUG

Mannitol

Participants are administered 600 mg Bronchitol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 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

Countries

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Denmark

Other Identifiers

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FOR

Identifier Type: -

Identifier Source: org_study_id

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