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Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289874
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : October 1, 2010
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a 3-week study to evaluate FEV1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 421 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Placebo Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral Montelukast Versus Placebo in Persistent Asthma Which is Also Active During Allergy Seasons in Pediatric Patients With Seasonal Aeroallergen Sensitivity
Study Start Date : March 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1
Drug: montelukast sodium
montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
Other Name: MK0476

Placebo Comparator: 2
Drug: Comparator: Placebo
Placebo. Up to 3 weeks of treatment

Primary Outcome Measures :
  1. Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 [ Time Frame: Baseline and week 3 ]
    Percent change from baseline in FEV1, a measure of airway function, at Week 3

Secondary Outcome Measures :
  1. Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period [ Time Frame: Baseline and Week 3 ]
    Percent change from baseline in average daily β-agonist use over the 3-week treatment period

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season
  • Patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens

Exclusion Criteria:

  • Patient cannot have any other acute or chronic pulmonary disorder

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 identifier (NCT number): NCT00289874

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00289874    
Other Study ID Numbers: 0476-336
First Posted: February 10, 2006    Key Record Dates
Results First Posted: October 1, 2010
Last Update Posted: February 17, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
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