Pediatric Allergic Asthma Study - 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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percent change from baseline in mean daily "as needed" B-agonist use [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment:	750
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
1: Experimental montelukast	Drug: montelukast sodium montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
2: Placebo Comparator 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

PhRMA Clinical Study Results Database - web-based repository for clinical study results 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:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_001, MK0476-336
Study First Received:	February 7, 2006
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00289874 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 09, 2010