Salbutamol, Pharmacogenetics and Breathing Mechanics
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01903785|
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : November 2, 2016
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Bronchoconstriction Inhaled Salbutamol Cycling Performance||Drug: Salbutamol Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Pharmacogenetic Effects of Inhaled Salbutamol on Breathing Mechanics and Cycling Performance|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||August 2016|
400ug of salbutamol (one single inhalation) will be inhaled 60min prior to the begin of a time trial. Mean power output during the following 10km time trial will be described to 1600ug salbutamol and placebo.
60 minutes prior to the start of a 10km cycling time trial on a bike ergometer, subjects will inhale either 400ug of salbutamol 1600ug of salbutamol or 400ug of placebo in a randomly assigned manner in a single dose.
Other Name: ventolin
Placebo Comparator: Placebo
400ug of placebo (one single inhalation) will be inhaled 60min prior to the begin of a time trial. Mean power output during the following 10km time trial will be described to 400ug and 1600ug salbutamol.
- The effect of inhaled salbutamol on mean power output during cycling performance in female and male athletes [ Time Frame: Mean power output is assessed over the duration of a 10km time trial (start of time trial until completion of time trial) on a bike ergometer. ]Athletes perform a two time trials, each on a separate day. The time trials are performed 60min after the inhalation of salbutamol or placebo.
- The effect of inhaled salbutamol on work of breathing (WOB) and expiratory flow limitation (EFL) in female and male athletes [ Time Frame: WOB and EFL will be assessed during an incremental exercise test. Exercise will start at 0 Watts and will then be increased every 2.5min by 30 Watts until maximal exertion. ]EFL and WOB will be assessed with the help of an esophageal balloon and mouth pressure.
- The effect of inhaled salbutamol on minute ventilation in asthmatic and non-asthmatic trained, female and male cyclists [ Time Frame: Minute ventilation will be assessed during two 10km time trials (one time trial will be started 60min after the inhalation of salbutamol, the second time trial will be started 60min after the inhalation of placebo). ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||19 Years to 45 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- trained, experienced cyclists
- maximal oxygen consumption of at least 50ml/kg/min or 4l/min for women; and 60ml/kg/min or 5l/min for men
- athletes with and without exercise-induced bronchoconstriction
- any uncontrolled heart or lung condition
- maximal oxygen consumption of less than 50ml/kg/min or 4L/min for women; and less than 60ml/kg/min or 5L/min for men
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903785
|Canada, British Columbia|
|Environmental Physiology Laboratory, University of British Columbia|
|Vancouver, British Columbia, Canada, V6T 1Z1|
|Principal Investigator:||Michael S Koehle, MD, PhD||University of British Columbia|
|Responsible Party:||University of British Columbia|
|Other Study ID Numbers:||
|First Posted:||July 19, 2013 Key Record Dates|
|Last Update Posted:||November 2, 2016|
|Last Verified:||October 2016|
exercise-induced bronchoconstriction (EIB)
Respiratory Tract Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action