EUCTR2005-004115-29-DEActive, not recruitingNot Applicable
Investigation to identify predictors of response to a treatment with montelukast
Research Institute for the prevention of allergy and airway diseases in childhood0 sitesStarted: September 8, 2005Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •·Children and adolescents with symptomatic bronchial asthma despite ongoing therapy
- •·Age 6-14 years
- •·Asthma diagnosed at lease six months previously (by a special pulmonary allergologic outpatient unit)
- •·Demonstration of reversibility (FEV1 increased by at least 12% after bronchospasmolysis with a beta2 sympathomimetic). This can be determined at the screening visit or within the previous three months.
- •·Patients who are either steroid-naive or who received constant doses of the following medications within the previous four weeks:
- •-Beclomethasone dipropionate: up to 400 µg daily
- •-Fluticasone propionate: up to 200 µg daily
- •-Budesonide: up to 400 µg daily
- •·Patients who are able to reliably complete the asthma diary and perform peak flow measurements according to instructions.
- •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
- •·Patients who were treated with systemic steroids within the previous 30 days
- •·Patients using one of the following asthma medications:
- •Systemic steroids
- •Nedocromil, DNCG
- •Theophylline
- •Systemic or long-acting beta2 sympathomimetics
- •·Patients who have experienced one of the following events within the previous 30 days:
- •A change in asthma medication
- •Pulmonary infection
- •Hospitalization due to bronchial asthma or any other respiratory condition
- •·Patients who are currently participating in another clinical trial or have done so within the previous 30 days.
- •·Patients known or expected to react hypersensitively to components of the investigational medication
Investigators
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