The effect of cold air on the airways of elite skaters and the protective role of the OMRO
- Conditions
- Exericise induced bronchoconstrictionTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2012-003600-12-NL
- Lead Sponsor
- Sportmedisch expertisecentrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Age between 18 and 35 years
- Elite speedskater
- Women: 1500 meter time below 2:10:00 minutes.
- Men: 1500 meter time below 02:05:00 minutes.
These times should have been skated within a period of two months prior to study measurement.
- Able to undergo reproducible lung function tests. Three-fold repetition of FEV1 measurements, with a mutual difference of maximal 5 percent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 41
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Ultrasonic nebulization within 48 hours before testing.
- FEV1 <70% of predicted.
- Respiratory infection within 6 weeks prior to examination for which medication should be prescribed.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a fall in FEV1 in elite speed skaters;Secondary Objective: - Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a change in airway resistance in elite speed skaters<br>- Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a change in airway reactance in elite speed skaters<br>- Analyze the effect of nebulized salbutamol or isotonic saline on exercise induced airway obstruction measured with a change in EMG activity or breathing musclesin elite speed skaters;Primary end point(s): -The difference in exercise induced fall of FEV1 after four minutes of treatment with salbutamol compared to nebulization with with salbutamol, 0.9% NaCl and controls.;Timepoint(s) of evaluation of this end point: 10, 15 and 30 minutes after exercise
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Analyze the change in exercise induced increase of airway resistance, measured with the FOT, after four minutes of treatment with salbutamol, 0.9% NaCl and controls. <br>-Analyze the change in exercise induced decrease of airway reactance, measured with the FOT, after four minutes of treatment with salbutamol, 0.9% NaCl and controls. <br>-Analyzing the change in the electro physiological activity of the respiratory muscle system, measured with EMG with Salbutamol ,isotonic saline and controls. <br>;Timepoint(s) of evaluation of this end point: 10, 15 and 30 minutes after exercise