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The protective effect of levocetirizine on exercise induced airway obstruction in cold air.

Phase 4
Withdrawn
Conditions
exercise induced airway obstruction
10038716
Registration Number
NL-OMON32040
Lead Sponsor
Medisch Spectrum Twente
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
24
Inclusion Criteria

- 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.

Exclusion Criteria

- 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 intranasal or systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study.
- Use of long acting bronchodilators 24 hours before testing.
- Use of short acting bronchodilators 8 hours before testing.
- 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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The reduction in exercise induced fall of FEV1, MIF50 and increase in airway<br /><br>resistance after a single dose of LEV. </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>not applicable</p><br>
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