Status:
COMPLETED
Investigation to Identify Predictors of Response to a Treatment With Montelukast
Lead Sponsor:
Marien Hospital Wesel
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Asthma
Eligibility:
All Genders
6-14 years
Phase:
PHASE4
Brief 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 pulmon...
Detailed Description
Leukotriene antagonists (montelukast) are particularly effective as controllers before exposure to an allergen (Leff 1998). The same applies to the treatment of bronchoconstriction induced by physical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00721240
Start Date
February 1 2006
End Date
June 1 2009
Last Update
February 17 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Marien Hospital Wesel gGmbH
Wesel, North Rhine-Westphalia, Germany, 46483