Exercise induced asthma / bronchoconstriction Asthma MedDRA version: 12.1 Level: LLT Classification code 10015649 Term: Exercise induced asthma MedDRA version: 12.1 Level: PT Classification code 10003553 Term: Asthma MedDRA version: 12.1 Level: PT Classification code 10066091 Term: Bronchial hyperreactivity
Conditions
Interventions
Trade Name: Qvar 100 Aerosol
Product Name: beclomethasone
Pharmaceutical Form: Inhalation vapour, solution
INN or Proposed INN: BECLOMETASONE DIPROPIONATE
CAS Number: 08/09/5534
Concentration unit: µg
Sponsors
Medisch Spectrum Twente
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age between 12-18 years - Clinical history of allergic asthma and exercise induced bronchoconstriction - Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements 70% of predicted value 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: What is the correlation between change in Mannitol PD15 (provoking dose of mannitol to cause a = 15% fall in FEV1 ) 6h after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone?;Secondary Objective: Which individual patient and disease characteristics are confounders for this correlation?;Primary end point(s): Correlation between change in Mannitol PD15 after a single dose of beclomethasone and after 4 weeks of treatment with beclomethasone. | — |
Countries
Netherlands
Outcome results
None listed