Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)
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|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|
|Actual Primary Completion Date :||December 2009|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770900
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|