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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

montelukast sodium

Comparator: Usual Care

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

6 Months - 2 Years (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Montelukast

Usual Care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00943397

First Posted

July 21, 2009

Last Updated

February 1, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00943397

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

April 2001 (undefined)

Primary Completion Date

October 2001 (Actual)

Study Completion Date

November 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

190 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Montelukast

Arm Title

Arm Type

Active Comparator

Arm Description

Usual Care

Intervention Type

Drug

Intervention Name(s)

montelukast sodium

Other Intervention Name(s)

Montelukast

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: Usual Care

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to 52 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

19449366

Citation

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.

Results Reference

result

Learn more about this trial

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

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