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Completed

NCT Number: NCT00943397

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

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.

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Key information

Conditions

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

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

montelukast sodium

Drug

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

Other names: Montelukast

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2001
Study completion
2001
First posted
Jul 22, 2009
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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