Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00770900|
Recruitment Status : Completed
First Posted : October 10, 2008
Last Update Posted : December 20, 2010
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: montelukast sodium Drug: Comparator: placebo comparator||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||83 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prospective, Randomized, Double-blind, Study to Evaluate the Eosinophils Activation Parameters and Phagocyte Function in Patients With Persistent Asthma Treated With Montelukast|
|Study Start Date :||September 2008|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
Asthmatic children and teenagers took montelukast daily.
Drug: montelukast sodium
Asthmatic children and teenagers took montelukast daily for 12 weeks.
Children aged 2-5 years took 4mg tablet of montelukast
Children aged 6-15 years took 5mg tablet of montelukast
Children >15 years took 10mg tablet of montelukast
Other Name: Singulair
Placebo Comparator: Placebo
Placebo to montelukast tablet daily.
Drug: Comparator: placebo comparator
Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.
- Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic. [ Time Frame: 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770900
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|