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

A Multicenter, Double-Blind, Randomized, Parallel-Group Chronic Asthma Study Comparing Montelukast With Placebo in 2- to 5-Year-Old Patients

A study in 2-5 year old children to evaluate the safety and tolerability of montelukast and placebo administered once daily at bed time.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: montelukast sodium; Drug: Comparator: Placebo

• Study Type: Interventional
• Enrollment (Actual): 689
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Montelukast	Drug: montelukast sodium; one chewable 4-mg montelukast tablet, once daily at bedtime for 12 weeks
PLACEBO_COMPARATOR: 2; Placebo	Drug: Comparator: Placebo; one chewable placebo tablet, once daily at bedtime for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study	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	12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Drug-related CAEs Reported by Patients - Base Study	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs	12 weeks of treatment
Number of Patients With Serious CAEs Reported by Patients - Base Study	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	12 weeks of treatment
Number of Patients With Serious Drug-related CAEs Reported by Patients - Base Study	Patients who reported serious drug-related CAEs during 12 weeks of treatment	12 weeks of treatment
Number of Patients Who Were Discontinued Due to CAEs - Base Study	Patients who were discontinued due to CAEs during 12 weeks of treatment	12 weeks of treatment
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Base Study	Patients who were discontinued due to drug-related CAEs during 12 weeks of treatment	12 weeks of treatment
Number of Patients Who Were Discontinued Due to Serious CAEs - Base Study	Patients who were discontinued due to serious CAEs during 12 weeks of treatment	12 weeks of treatment
Number of Patients With Laboratory Adverse Experiences (LAEs) - Base Study	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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	12 weeks of treatment
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Base Study	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs	12 weeks of treatment
Number of Patients Who Were Discontinued Due to LAEs - Base Study	Patients who were discontinued due to LAEs during 12 weeks of treatment	12 weeks of treatment
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Base Study	Patients who were discontinued due to drug-related LAEs during 12 weeks of treatment	12 weeks of treatment
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Extension	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 2.8 years
Number of Patients With Drug-related CAEs Reported by Patients - Extension	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs	up to 2.8 years
Number of Patients With Serious CAEs Reported by Patients - Extension	Serious CAEs are any AEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	up to 2.8 years
Number of Patients With Serious Drug-related CAEs Reported by Patients - Extension	Patients who reported serious drug-related CAEs up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to CAEs - Extension	Patients who were discontinued due to CAEs up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to Drug-related CAEs - Extension	Patients who were discontinued due to drug-related CAEs with up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious CAEs - Extension	Patients who were discontinued due to serious CAEs with up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious Drug-related CAEs - Extension	Patients who were discontinued due to serious drug-related CAEs with up to 2.8 years of treatment	up to 2.8 years
Number of Patients With Laboratory Adverse Experiences (LAEs) - Extension	A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the 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 2.8 years
Number of Patients With Drug-related Laboratory Adverse Experiences (LAEs) - Extension	Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs	up to 2.8 years
Number of Patients With Serious LAEs - Extension	Serious LAEs are any LAEs occurring at any dose that; Results in death; or Is life threatening; or Results in a persistent or significant disability/incapacity; or Results in or prolongs an existing inpatient hospitalization; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose	up to 2.8 years
Number of Patients With Serious Drug-related Laboratory Adverse Experiences (LAEs) - Extension	Patients who reported serious drug-related LAEs up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to LAEs - Extension	Patients who were discontinued due to LAEs up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to Drug-related LAEs - Extension	Patients who were discontinued due to drug-related LAEs with up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious LAEs - Extension	Patients who were discontinued due to serious LAEs with up to 2.8 years of treatment	up to 2.8 years
Number of Patients Who Were Discontinued Due to Serious Drug-related LAEs - Extension	Patients who were discontinued due to serious drug-related LAEs with up to 2.8 years of treatment	up to 2.8 years

Collaborators and Investigators

• Sponsor: Organon and Co

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 1997
• Primary Completion (ACTUAL): March 1, 2001
• Study Completion (ACTUAL): March 1, 2001

Study Registration Dates

• First Submitted: August 27, 2009
• First Submitted That Met QC Criteria: August 27, 2009
• First Posted (ESTIMATE): August 28, 2009

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 1, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: 0476-072; 2009_651