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Montelukast Back to School Asthma Study (0476-340)

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ClinicalTrials.gov Identifier: NCT00461032
Recruitment Status : Completed
First Posted : April 17, 2007
Results First Posted : February 4, 2010
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: montelukast Drug: Comparator: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2006
Primary Completion Date : November 2006
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
montelukast
Drug: montelukast
montelukast 5 mg tablet Once a day (QD) for 8 weeks
Placebo Comparator: 2
Placebo
Drug: Comparator: Placebo
Placebo to montelukast QD for 8 weeks


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461032


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00461032     History of Changes
Other Study ID Numbers: 0476-340
MK0476-340
2007_539
First Posted: April 17, 2007    Key Record Dates
Results First Posted: February 4, 2010
Last Update Posted: March 3, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action