Clinical trial NCT00968201: Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-08-28
Enrollment: 689
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.


Eligibility criteria: Inclusion Criteria:

* Patient has history of physician diagnosed asthma
* Patient is in otherwise good stable health
* Patient is able to chew a tablet

Exclusion Criteria:

* Patient is hospitalized
* Patient and/or parent of guardian intends to move or vacation away from home during the course of the study
* Patient had any major surgical procedure within 4 weeks before the study
* Patient had active sinus disease within 3 weeks before the study
* Patient had required intubation for asthma in the past
* Patient required a visit to the emergency room due to an asthma exacerbation, or has been hospitalized for asthma with in 1 month prior to the study
* Patient had used inhaled, nebulized, intramuscular, or intravenous steroids with in 1 month before study

Primary outcomes:
measure: Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Number of Patients With Drug-related CAEs Reported by Patients - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients With Serious CAEs Reported by Patients - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients Who Were Discontinued Due to CAEs - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients Who Were Discontinued Due to LAEs - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study
timeFrame: 12 weeks of treatment
measure: Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Drug-related CAEs Reported by Patients - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Serious CAEs Reported by Patients - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to CAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to Serious CAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Serious LAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to LAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to Serious LAEs - Extension
timeFrame: up to 2.8 years
measure: Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension
timeFrame: up to 2.8 years
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Knorr B, Franchi LM, Bisgaard H, Vermeulen JH, LeSouef P, Santanello N, Michele TM, Reiss TF, Nguyen HH, Bratton DL. Montelukast, a leukotriene receptor antagonist, for the treatment of persistent asthma in children aged 2 to 5 years. Pediatrics. 2001 Sep;108(3):E48. doi: 10.1542/peds.108.3.e48.