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Recruiting NCT06067100

U-LABA/ICS Effects on Exercise Performance, Indacaterol

No phase Interventional Exercise Performance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indacaterol and Mometasonefluroate (low dose), Placebo, Indacaterol and Mometasonefluroate (high dose).
Who it may be relevant to
Registry conditions: Exercise Performance. Basic parameters: 18 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Indacaterol and Mometasonefluroate (low dose)
    Participants are administered 125 µg indacaterol + mometasonefluroate
  • Drug Placebo
    Participants are administered placebo
  • Drug Indacaterol and Mometasonefluroate (high dose)
    Participants are administered 500 µg indacaterol + mometasonefluroate

Primary outcome measures

  • Power output during sprint testing [Time frame: Through study completion, an average of 3 weeks]
Secondary outcome measures (4)
  • Power output during time trial [Time frame: Through study completion, an average of 3 weeks]
  • Forced Expiratory Volume in 1 second (FEV1) [Time frame: Through study completion, an average of 3 weeks]
  • Quadriceps strength [Time frame: Through study completion, an average of 3 weeks]
  • Respiratory muscle function [Time frame: Through study completion, an average of 3 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • August Krogh Building — Copenhagen

Identifiers

NCT: NCT06067100 · INDAC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗