Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED) - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00289874

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 III

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

Drug Information available for: Montelukast sodium Montelukast

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:

Papadopoulos NG, Philip G, Giezek H, Watkins M, Smugar SS, Polos PG. The efficacy of montelukast during the allergy season in pediatric patients with persistent asthma and seasonal aeroallergen sensitivity. J Asthma. 2009 May;46(4):413-20.

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 February 09, 2012