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

NCT ID: NCT00943397

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2001-11-30

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Montelukast

Group Type: EXPERIMENTAL

montelukast sodium

Intervention Type: DRUG

Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks

2

Usual Care

Group Type: ACTIVE_COMPARATOR

Comparator: Usual Care

Intervention Type: DRUG

Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Interventions

montelukast sodium

Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks

Intervention Type: DRUG

Comparator: Usual Care

Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks

Intervention Type: DRUG

Other Intervention Names

Montelukast

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.

Reference Type: RESULT

PMID: 19449366 (View on PubMed)

Other Identifiers

MK0476-232

Identifier Type: -

Identifier Source: secondary_id

2009_619

Identifier Type: -

Identifier Source: secondary_id

0476-232

Identifier Type: -

Identifier Source: org_study_id