The predictive value of the acute effect of beclomethasone on a mannitol challenge test for the outcome of longterm treatment with beclomethasone

Phase 4

Completed

• Conditions: exercise induced bronchoconstriction; 10006436

• Registration Number: NL-OMON38395
• Lead Sponsor: Medisch Spectrum Twente

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 19

Inclusion Criteria

- Age between 12-18 years
- Clinical history of allergic asthma and exercise induced bronchoconstriction
- Ability to perform reproducible lung function tests (predicted value variation in 3 of 5 consecutive measurements < 5%)
- Maximal FEV1 > 70% of predicted value

Exclusion Criteria

- Other pulmonary or cardiac illnesses
- Maximal FEV1 < 70% of predicted value
- Use of nasal or systemic corticosteroids, antihistamines, cromoglycates, anticholinergics or leukotriene antagonists in two weeks prior to or during the study
- Use of long acting bronchodilator agents 24 hours before testing
- Use of short acting bronchodilator agents 8 hours before testing
- Hospitalization due to asthma exacerbation in past month
- Other changes in asthma medication during treatment period
- Upper or lower respiratory tract infections during treatment period
- Deviation of the FEV1 before the subsequent mannitol challenges of more than 12 % from baseline FEV1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Correlation between change in Mannitol PD15 after a single dose of<br /><br>beclomethasone and after 4 weeks of treatment with beclomethasone.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Which individual patient and disease characteristics are confounders for this<br /><br>correlation?</p><br>