Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)(COMPLETED) - Full Text View

Sponsor:	Merck
Information provided by (Responsible Party):	Merck
ClinicalTrials.gov Identifier:	NCT00442559

Purpose

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Condition	Intervention	Phase
Asthma Allergic Rhinitis	Drug: montelukast sodium Drug: Comparator: inhaled corticosteroid	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast Corticosteroids

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Change From Baseline for Daytime Asthma Symptom Score [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.

Secondary Outcome Measures:

Change From Baseline for Daily Allergic Rhinitis Symptom Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.

Enrollment:	191
Study Start Date:	February 2005
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 montelukast sodium	Drug: montelukast sodium Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks Other Name: Singulair
Active Comparator: 2 inhaled corticosteroid	Drug: Comparator: inhaled corticosteroid Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks

Eligibility

Ages Eligible for Study:	2 Years to 14 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Between 2 and 14 years old
Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
Diagnosed with comorbid allergic rhinitis

Exclusion Criteria:

Patients with suspected sinus infection
Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442559

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT00442559 History of Changes
Other Study ID Numbers:	MK-0476-367, 2007_003
Study First Received:	February 28, 2007
Results First Received:	October 12, 2008
Last Updated:	November 16, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Asthma
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases

Respiratory Tract Infections
Otorhinolaryngologic 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