U-LABA/ICS Effects on Exercise Performance, Formoterol

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06105671

Enrollment

Registered

2023-10-30

Start date

2024-01-05

Completion date

2024-07-04

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Performance

Brief 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.

Interventions

DRUGSymbicort

Participants are administered 54 μg Formoterol and 1920 μg Budesonide

DRUGFormoterol

Participants are administered 54 μg Formoterol from an inhaler device

DRUGPlacebo

Participants are administered placebo

DRUGMannitol

Participants are administered 600 mg Bronchitol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Power output during time trial	Through study completion, an average on 4 weeks	Mean power output measured in Watts during a time trial on a bike ergometer

Secondary

Measure	Time frame	Description
Power output during sprint testing	Through study completion, an average on 4 weeks	Power output measured in Watts during a sprint on a bike ergometer

Other

Measure	Time frame	Description
Quadriceps strength	Through study completion, an average on 4 weeks	Maksimal torque (Nm) achieved during isometric contraction
Forced Expiratory Volume in 1 second (FEV1)	Through study completion, an average on 4 weeks	FEV1 measured by spirometry
Respiratory muscle function	Through study completion, an average on 4 weeks	Mouth inspiratory and expiratory pressures against a closed system

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026