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NCT Number: NCT06067100

U-LABA/ICS Effects on Exercise Performance, Indacaterol

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

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Key information

Conditions

Exercise Performance

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Morten Hostrup, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indacaterol and Mometasonefluroate (low dose)

Drug

Participants are administered 125 µg indacaterol + mometasonefluroate

Placebo

Drug

Participants are administered placebo

Indacaterol and Mometasonefluroate (high dose)

Drug

Participants are administered 500 µg indacaterol + mometasonefluroate

Primary outcomes

  1. Power output during sprint testing

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

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

Secondary outcomes

  1. Power output during time trial

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

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

  2. Forced Expiratory Volume in 1 second (FEV1)

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

    FEV1 measured by spirometry

  3. Quadriceps strength

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

    Maximal torque (Nm) achieved during isometric contraction

  4. Respiratory muscle function

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

    Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter)

Study contacts

Contact information is provided by the study sponsor or research team.

Morten Hostrup, PhD

CONTACT

[email protected]

+4535321595

Sponsors and collaborators

Lead sponsor

Morten Hostrup, PhD

Other

Registry information

Official study title

Physiological Response to U-LABA/ICS With Emphasis on Exercise Performance, Indacaterol

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 4, 2023
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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