Investigation to identify predictors of response to a treatment with montelukast

• Conditions: asthma bronchiale in childhood

• Registration Number: EUCTR2005-004115-29-DE
• Lead Sponsor: Research Institute for the prevention of allergy and airway diseases in childhood

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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
Ketotifen
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified