Investigation to Identify Predictors of Response to a Treatment With Montelukast

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The main aim of the study is to develop a method that allows responders to be distinguished from non-responders before long-term treatment is initiated. Subsidiary aims are to record changes in pulmonary functional parameters, NO concentrations and peak flow variability, the use of beta2 sympathomimetics and the asthma symptom score.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marien Hospital Wesel
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

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 medi¬cations 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.

• Girls of childbearing potential must have acceptable methods of contraceptions, including sexual abstinence.

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

• Patients receiving Phenobarbital, Phenytoin, Rifampicin (medications that are metabolized by Cytochrom P450

• Patients with analgetic intolerance

• Pregnant females