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

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: May 17, 2016
Last verified: May 2016

February 28, 2007
May 17, 2016
January 2005
October 2007   (final data collection date for primary outcome measure)
Change From Baseline for Daytime Asthma Symptom Score [ Time Frame: Baseline and Week 12 ] [ 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.
Daytime asthma symptom score at 12 weeks
Complete list of historical versions of study NCT00442559 on ClinicalTrials.gov Archive Site
Change From Baseline for Daily Allergic Rhinitis Symptom Score [ Time Frame: Baseline and Week 12 ] [ 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.
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Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis
The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Asthma
  • Allergic Rhinitis
  • Drug: montelukast sodium
    Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months
    Other Name: Singulair, MK0476
  • Drug: inhaled corticosteroid
    Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
  • Experimental: Montelukast
    Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
    Intervention: Drug: montelukast sodium
  • Active Comparator: Inhaled Corticosteroids (ICS)
    Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
    Intervention: Drug: inhaled corticosteroid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
191
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
2 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Korea, Republic of
 
NCT00442559
0476-367, 2007_003
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Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP