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

Overview

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.

Full Title of Study: “A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2001

Interventions

  • Drug: montelukast sodium
    • Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks
  • 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

Arms, Groups and Cohorts

  • Experimental: 1
    • Montelukast
  • Active Comparator: 2
    • Usual Care

Clinical Trial Outcome Measures

Primary Measures

  • Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 2 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Organon and Co
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme LLC

Citations Reporting on Results

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.

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