Phase 3
Completed N=190
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Source: ClinicalTrials.gov NCT00943397 ↗Enrolled (actual)
190
Serious AEs
8.4%
Results posted
Jun 2010
Primary outcomePrimary: Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment — 31; 156; 1; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment |
31; 156; 1; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00943397). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.