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

February 1, 2022 updated by: Organon and Co

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
689

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Clinical Adverse Experiences (CAE) Reported by Patients - Base Study
Time Frame: 12 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
12 weeks of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Patients With Drug-related CAEs Reported by Patients - Base Study
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: 12 weeks of treatment
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years

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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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
Time Frame: up to 2.8 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Organon and Co

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 1997

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2001

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2001

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0476-072
  • 2009_651

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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