Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
- Registration Number
- NCT00943397
- Lead Sponsor
- Organon and Co
- Brief Summary
Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
- Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)
OR:
- Patient is in good, stable health
- Patient has been fed solid foods for at least 1 month
- Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
- Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines
Exclusion Criteria
- Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior
- Patient had an allergy to apples or applesauce
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 montelukast sodium Montelukast
- Primary Outcome Measures
Name Time Method Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment Up to 52 weeks of treatment An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
- Secondary Outcome Measures
Name Time Method