The predictive value of the acute effect of beclomethasone-dipropionate on a mannitol challenge test for the outcome of longterm treatment with beclomethasone-dipropionate in childhood asthma

Phase 1

Conditions: exercise induced bronchoconstrictionasthma
MedDRA version: 19.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-002276-27-NL

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Are the trial subjects under 18? yes
Number of subjects for this age range: 25
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

Exclusion Criteria

- Other pulmonary or cardiac illnesses
- Maximal FEV1 < 70% of predicted value
- Use of nasal or systemic or inhalation 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: What is the correlation in mannitol PD15 (provoking dose of mannitol to cause >15% fall in FEV1) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?;Secondary Objective: not applicable;Primary end point(s): correlation between change in mannitol PD15 after a single dose of beclomethasone-dipropionate and after 4 weeks of treatment with beclomethasone-dipropionate;Timepoint(s) of evaluation of this end point: 1 day and 4 weeks

Secondary Outcome Measures