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The effect of cold air on the airways of elite skaters and the protective role of the OMRON

The effect of cold air on the airways of elite skaters and the protective role of the OMRON - OMRON and elite skaters

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-003600-12-NL
Enrollment
Unknown
Registered
2012-08-23
Start date
2012-10-29
Completion date
Unknown
Last updated
2012-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exericise induced bronchoconstriction

Interventions

Trade Name: Ventolin Product Name: Salbutamol Product Code: R03CC03 Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Nebuliser solution Route of administration of t

Sponsors

Sportmedisch expertisecentrum
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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.

Design outcomes

Primary

MeasureTime frame
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 - 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 - 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

MeasureTime frame
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. -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. -Analyzing the change in the electro physiological activity of the respiratory muscle system, measured with EMG with Salbutamol ,isotonic saline and controls. ;Timepoint(s) of evaluation of this end point: 10, 15 and 30 minutes after exercise

Countries

Netherlands

Contacts

Public ContactJean Driessen

Sportmedisch Expertisecentrum

jean.driessen@tjongerschans.nl00310513486486

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026