The protective effect of a nasal corticosteroid (Avamys) on exercise induced airway obstruction in cold air. - YSCO
- Conditions
- Exercise induced airway obstructionMedDRA version: 9.1Level: LLTClassification code 10003557Term: Asthma exercise inducedMedDRA version: 9.1Level: LLTClassification code 10001723Term: Allergic rhinitis
- Registration Number
- EUCTR2009-010563-17-NL
- Lead Sponsor
- Stichting Pediatrisch Onderzoek Enschede
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- Clinical history of allergic rhinitis and/or allergic asthma.
- Age between 12 and 17 years.
- Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
- Maximal FEV1 greater than 70% of predicted value.
- Clinically stable period at least 3 weeks before the study period.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study.
- Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study.
- Use of long acting bronchodilators 24 hours before testing.
- Use of short acting bronchodilators 8 hours before testing.
- Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study.
- Other pulmonary or cardiac disorder.
- Deviation of the FEV1 of more than 12 % from baseline spirometry and the FEV1 before subsequent exercise provocation challenges.
- Signs of gastro-esophageal reflux.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method