Skip to main content
OpenTrials
Completed

NCT Number: NCT06105671

U-LABA/ICS Effects on Exercise Performance, Formoterol

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Exercise Performance

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Symbicort

Drug

Participants are administered 54 μg Formoterol and 1920 μg Budesonide

Formoterol

Drug

Participants are administered 54 μg Formoterol from an inhaler device

Placebo

Drug

Participants are administered placebo

Mannitol

Drug

Participants are administered 600 mg Bronchitol

Primary outcomes

  1. Power output during time trial

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

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

Secondary outcomes

  1. Power output during sprint testing

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

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

Other outcomes

  1. Quadriceps strength

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

    Maksimal torque (Nm) achieved during isometric contraction

  2. Forced Expiratory Volume in 1 second (FEV1)

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

    FEV1 measured by spirometry

  3. Respiratory muscle function

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

    Mouth inspiratory and expiratory pressures against a closed system

Sponsors and collaborators

Lead sponsor

Morten Hostrup, PhD

Other

Registry information

Official study title

Physiological Responses to U-LABA/ICS With Emphasis on Exercise Performance in Well-Trained Individuals, Formoterol

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 30, 2023
Registry last updated
Aug 13, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.