Montelukast in Mild Asthmatic Children With Allergic Rhinitis - Full Text View

Sponsor:	Merck
Information provided by:	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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 ]

Secondary Outcome Measures:

Change From Baseline for Daily Allergic Rhinitis Symptom Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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
1: Experimental montelukast sodium	Drug: montelukast sodium Montelukast 4/5 mg tablet (oral chewable), once daily, 12wks
2: Active Comparator inhaled corticosteroid	Drug: Comparator: inhaled corticosteroid Inhaled corticosteroid solution, 1-4 puffs daily, 12wks

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 with nasal-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

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

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_003, MK0476-367
Study First Received:	February 28, 2007
Results First Received:	October 12, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00442559 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Additional relevant MeSH terms:

Respiratory System Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Rhinitis

Nose Diseases
Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010