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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00442559
First received: February 28, 2007
Last updated: August 21, 2013
Last verified: August 2013
  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 4

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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00442559     History of Changes
Other Study ID Numbers: 0476-367, 2007_003
Study First Received: February 28, 2007
Results First Received: October 12, 2008
Last Updated: August 21, 2013
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 April 17, 2014