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Physiological Response to Salbutamol and Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902106
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
Morten Hostrup, PhD, University of Copenhagen

Tracking Information
First Submitted Date  ICMJE March 26, 2019
First Posted Date  ICMJE April 3, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE March 28, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • Body composition [ Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks ]
    Change in body composition (measured by dual energy x ray absorptiometry)
  • Maximal oxygen consumption (VO2max) [ Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks ]
    Change in VO2max (measured during bike ergometer cycling to exhaustion)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
Salbutamol urine concentration [ Time Frame: Before (baseline) as well as 0-1 hours, 1-2 hours, 2-4 hours, 4-8 hours, and 8-16 hours after administration ]
Concentration of salbutamol in urine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2020)
Muscle strength [ Time Frame: Baseline, 2 weeks, 4 weeks and 6 weeks ]
Isometric muscle force of the quadriceps
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physiological Response to Salbutamol and Exercise
Official Title  ICMJE Physiological Response to Salbutamol and Exercise
Brief Summary The scope of the study is to investigate the physiological response to salbutamol and exercise. A particular focus is on the metabolic response and amine metabolism.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: salbutamol
    subjects ingest salbutamol
  • Other: exercise
    subjects undergo 6 weeks of endurance training (3 times weekly)
Study Arms  ICMJE
  • Active Comparator: beta2-agonist and exercise
    Subjects undergo exercise training with administration of salbutamol (800 microgram in 12 hours x 2)
    Interventions:
    • Drug: salbutamol
    • Other: exercise
  • Sham Comparator: placebo and exercise
    Subjects undergo exercise training with administration of sham placebo
    Intervention: Other: exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy
  • VO2max of >55 ml/min/kg for men and >50 ml/min/kg for women
  • Body mass index (BMI) < 26

Exclusion Criteria:

  • Chronic use of beta2-agonist or allergy towards beta2-agonist
  • Serious adverse effects to beta2-agonist
  • Chronic disease deemed by the study responsible medical doctor to interfere with any part of the study
  • Smoking
  • Chronic use of prescription medicine deemed by the study responsible medical doctor to interfere with any part of the study
  • Pregnancy (for women)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03902106
Other Study ID Numbers  ICMJE SALB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Morten Hostrup, PhD, University of Copenhagen
Study Sponsor  ICMJE University of Copenhagen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Copenhagen
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP