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

NCT00943397 | Completed Phase 3 Results

• 3 other identifiers: 0476-232MK0476-2322009_619
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Clinical Adverse Experiences (CAEs) Reported by Patients With 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

  Up to 52 weeks of treatment

Study Arms (2)

1

EXPERIMENTAL

Montelukast

Drug: montelukast sodium

2

ACTIVE COMPARATOR

Usual Care

Drug: Comparator: Usual Care

Interventions

montelukast sodium DRUG

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

Also known as: Montelukast

1

Comparator: Usual Care 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

2

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 19449366 RESULT

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2009
• First Posted: July 22, 2009
• Study Start: April 1, 2001
• Primary Completion: October 1, 2001
• Study Completion: November 1, 2001
• Last Updated: February 3, 2022
• Results First Posted: June 17, 2010

Record last verified: 2022-02