Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: Comparator: Usual Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943397

2009_619

MK0476-232

0476-232

Details and patient eligibility

About

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.

Enrollment: 190 patients

Sex: All

Ages: 6 months to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

1

Experimental group

Description:

Montelukast

Treatment:

Drug: montelukast sodium

2

Active Comparator group

Description:

Usual Care

Treatment:

Drug: Comparator: Usual Care