- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04616261
Beta2-adrenergic System and Training
November 3, 2020 updated by: Morten Hostrup, PhD, University of Copenhagen
Trainability of the beta2-adrenergic System With Respect to Performance
This project aims to examine the trainability of the beta2-adrenergic system with respect to the individual performance response
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 18 to 45 years of age
- Trained individuals with a maximal oxygen uptake above 55 ml/min/kg
- Body mass index lower than 26
Exclusion Criteria:
- Allergy towards study drug
- Unacceptable side effects to the study drug
- Chronic disease deemed by the MD to interfere with the study
- Smoking
- Use of prescription medicine
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SET-HIGH
High volume speed endurance training
|
6 weeks of training
inhalation of 54 microg formoterol
inhalation of placebo
|
Experimental: SET-LOW
Low volume speed endurance training
|
6 weeks of training
inhalation of 54 microg formoterol
inhalation of placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sprint performance
Time Frame: ½ hour after administration of formoterol or placebo
|
Change in power output during maximal cycling in response to formoterol
|
½ hour after administration of formoterol or placebo
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cycling endurance performance
Time Frame: ½ hour after administration of formoterol or placebo
|
Change in 4-min time trial performance in response to formoterol
|
½ hour after administration of formoterol or placebo
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 10, 2020
Primary Completion (Anticipated)
November 10, 2022
Study Completion (Anticipated)
November 10, 2022
Study Registration Dates
First Submitted
October 29, 2020
First Submitted That Met QC Criteria
November 3, 2020
First Posted (Actual)
November 4, 2020
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Formoterol Fumarate
Other Study ID Numbers
- FOREX
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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