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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03565302
Other study ID # FOR/TER
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 25, 2018
Est. completion date May 30, 2021

Study information

Verified date March 2020
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to investigate gender-specific adaptations to beta2-adrenoceptor stimulation with selective short- and long-acting beta2-agonist with emphasis on skeletal muscle in relation to performance enhancing effects and anti-doping


Recruitment information / eligibility

Status Recruiting
Enrollment 72
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy men and women, aged 18-45 years

- VO2max >55 ml/kg/min for men and >50 ml/kg/min for women (± biologic and techinical variation of 5.6% (Katch et al. 1982)

- Body Mass Index (BMI) < 26

Exclusion Criteria:

- Chronic user of beta2-agonist or allergy towards study drugs

- Serious adverse side effects of the used study drug

- Chronic disease that by the project physician would affect any of the outcomes of the study

- Smoker

- Chronic use of prescription medication (other than contraceptives for women)

- Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Formoterol
Subjects are treated with daily inhalation of formoterol
Terbutaline
Subjects are treated with daily inhalation of terbutaline
Other:
Placebo
Subjects are treated with placebo

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 Drug exposure Measured in urine using enantiomeric analysis Day 1-14 and day 49-56
Primary Proteome enrichment Change in enrichment (measured in muscle biopsies and assessed using GO annotations) Baseline and 6 weeks
Secondary Body composition Change in body composition (measured by dual energy x ray absorptiometry) Baseline, 2 weeks, 4 weeks and 6 weeks
Secondary Maximal oxygen consumption (VO2max) Change in VO2max (measured during bike ergometer cycling to exhaustion) Baseline, 2 weeks, 4 weeks and 6 weeks
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