Montelukast Back to School Asthma Study (0476-340)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: April 13, 2007
Last updated: June 23, 2015
Last verified: June 2015
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 Intervention Phase
Drug: montelukast
Drug: Comparator: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.

  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.

Enrollment: 1162
Study Start Date: June 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: montelukast
montelukast 5 mg tablet Once a day (QD) for 8 weeks
Placebo Comparator: 2
Drug: Comparator: Placebo
Placebo to montelukast QD for 8 weeks


Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00461032

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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00461032     History of Changes
Other Study ID Numbers: 0476-340  MK0476-340  2007_539 
Study First Received: April 13, 2007
Results First Received: January 12, 2010
Last Updated: June 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on February 11, 2016