U-LABA/ICS Effects on Exercise Performance, Formoterol

Exercise Performance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06105671
• Other study ID #: FOR
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: November 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 well-trained individuals in a crossover design following varying degrees of bronchodilation/constriction intervention using current standard procedures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Exercise Performance

Intervention

Drug:
• Symbicort
Participants are administered 54 µg Formoterol and 1920 µg Budesonide
• Formoterol
Participants are administered 54 µg Formoterol from an inhaler device
• Formoterol
Participants are administered 120 µg Formoterol in a capsule, which is taken orally
• Placebo
Participants are administered placebo
• Mannitol
Participants are administered 600 mg Bronchitol

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
Other	Quadriceps strength	Maksimal torque (Nm) achieved during isometric contraction	Through study completion, an average on 4 weeks
Other	Forced Expiratory Volume in 1 second (FEV1)	FEV1 measured by spirometry	Through study completion, an average on 4 weeks
Other	Respiratory muscle function	Mouth inspiratory and expiratory pressures against a closed system	Through study completion, an average on 4 weeks
Primary	Power output during time trial	Mean power output measured in Watts during a time trial on a bike ergometer	Through study completion, an average on 4 weeks
Secondary	Power output during sprint testing	Power output measured in Watts during a sprint on a bike ergometer	Through study completion, an average on 4 weeks