U-LABA/ICS Effects on Exercise Performance, Indacaterol

Exercise Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067100
• Other study ID #: INDAC
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: University of Copenhagen
• Contact: Morten Hostrup, PhD
• Phone: +4535321595
• Email: mhostrup[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Performance

Intervention

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

Locations

Country	Name	City	State
Denmark	August Krogh Building	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Morten Hostrup, PhD

Country where clinical trial is conducted

Denmark, 

Outcome

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