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Completed

NCT Number: NCT00461032

Montelukast Back to School Asthma Study (0476-340)

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

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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 year–14 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

  • Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion criteria

  • Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

Treatment and study plan

Montelukast

Drug

montelukast 5 mg tablet Once a day (QD) for 8 weeks

Comparator: placebo

Drug

Placebo to montelukast QD for 8 weeks

Primary outcomes

  1. Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

    Time frame: 8 Week treatment period initiated at the beginning of a school year

    A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.

Secondary outcomes

  1. Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)

    Time frame: 8 Week treatment period initiated at the beginning of a school year

    Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.

  2. Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

    Time frame: 8 Week treatment period initiated at the beginning of a school year

  3. Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

    Time frame: 8 Week treatment period initiated at the beginning of a school year

    Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 17, 2007
Registry last updated
Feb 2, 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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