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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00289874
First received: February 7, 2006
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Asthma
 Drug: montelukast sodium
Drug: Comparator: Placebo
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 [ Time Frame: Baseline and week 3 ] [ Designated as safety issue: No ]
    Percent change from baseline in FEV1, a measure of airway function, at Week 3


Secondary Outcome Measures:
  • Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period [ Time Frame: Baseline and Week 3 ] [ Designated as safety issue: No ]
    Percent change from baseline in average daily β-agonist use over the 3-week treatment period


Enrollment: 421
Study Start Date: March 2006
Study Completion Date: August 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
montelukast
 Drug: montelukast sodium
montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
Other Name: MK0476
Placebo Comparator: 2
placebo
 Drug: Comparator: Placebo
Placebo. Up to 3 weeks of treatment

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289874

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00289874     History of Changes
Other Study ID Numbers: 2006_001, MK0476-336
Study First Received: February 7, 2006
Results First Received: September 9, 2009
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013