U-LABA/ICS Effects on Exercise Performance, Indacaterol

Not Applicable

Recruiting

• Conditions: Exercise Performance
• Interventions: Drug: Indacaterol and Mometasonefluroate (low dose); Drug: Placebo; Drug: Indacaterol and Mometasonefluroate (high dose)

• Registration Number: NCT06067100
• Lead Sponsor: Morten Hostrup, PhD

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-27
• Study First Posted: 2023-10-04
• Study Start: 2024-01-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2026-07-15
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Indacaterol + mometasonefluroate	Indacaterol and Mometasonefluroate (low dose)	-
Indacaterol + mometasonefluroate	Indacaterol and Mometasonefluroate (high dose)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Power output during sprint testing	Through study completion, an average of 3 weeks	Power output measured in Watts during a sprint on a bike ergometer

Secondary Outcome Measures

Name	Time	Method
Power output during time trial	Through study completion, an average of 3 weeks	Mean power output measured in Watts during a time trial on a bike ergometer
Forced Expiratory Volume in 1 second (FEV1)	Through study completion, an average of 3 weeks	FEV1 measured by spirometry
Quadriceps strength	Through study completion, an average of 3 weeks	Maximal torque (Nm) achieved during isometric contraction
Respiratory muscle function	Through study completion, an average of 3 weeks	Mouth inspiratory and expiratory pressures (MD Diagnostics, RP-check, handheld respiratory pressure meter)

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark