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Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00289874
First Posted: February 10, 2006
Last Update Posted: February 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
February 7, 2006
February 10, 2006
September 9, 2009
October 1, 2010
February 17, 2016
March 2006
July 2007   (Final data collection date for primary outcome measure)
Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 3 [ Time Frame: Baseline and week 3 ]
Percent change from baseline in FEV1, a measure of airway function, at Week 3
Percent change from baseline in Forced Expiratory Volume in 1 minute (FEV1)
Complete list of historical versions of study NCT00289874 on ClinicalTrials.gov Archive Site
Percent Change From Baseline in Mean Daily "as Needed" β-agonist Use Over the 3-week Treatment Period [ Time Frame: Baseline and Week 3 ]
Percent change from baseline in average daily β-agonist use over the 3-week treatment period
Percent change from baseline in mean daily "as needed" rescue medication use
Not Provided
Not Provided
 
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: montelukast sodium
    montelukast 5 mg chewable tablet once daily. Up to 3 weeks of treatment.
    Other Name: MK0476
  • Drug: Comparator: Placebo
    Placebo. Up to 3 weeks of treatment
  • Experimental: 1
    montelukast
    Intervention: Drug: montelukast sodium
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Comparator: Placebo
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. doi: 10.1080/02770900902847727. Erratum in: J Asthma. 2009 Oct;46(8):858.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
421
July 2007
July 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Years to 14 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00289874
0476-336
2006_001
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
January 2016

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