Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )

NCT ID: NCT00968201

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 689 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-12-31
• Study Completion Date: 2001-03-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Montelukast

Group Type: EXPERIMENTAL

montelukast sodium

Intervention Type: DRUG

one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

2

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

one chewable placebo tablet, once daily at bedtime for 12 weeks

Interventions

montelukast sodium

one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks

Intervention Type: DRUG

Comparator: Placebo

one chewable placebo tablet, once daily at bedtime for 12 weeks

Intervention Type: DRUG

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 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

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.

Reference Type: RESULT

PMID: 11533366 (View on PubMed)

Other Identifiers

2009_651

Identifier Type: -

Identifier Source: secondary_id

0476-072

Identifier Type: -

Identifier Source: org_study_id