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

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.
 
ClinicalTrials.gov Identifier: NCT00289874
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : October 1, 2010
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 10, 2006
Results First Submitted Date  ICMJE September 9, 2009
Results First Posted Date  ICMJE October 1, 2010
Last Update Posted Date February 17, 2016
Study Start Date  ICMJE March 2006
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 8, 2006)
Percent change from baseline in Forced Expiratory Volume in 1 minute (FEV1)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2010)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2006)
Percent change from baseline in mean daily "as needed" rescue medication use
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    montelukast
    Intervention: Drug: montelukast sodium
  • Placebo Comparator: 2
    placebo
    Intervention: Drug: Comparator: Placebo
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2010)
421
Original Enrollment  ICMJE
 (submitted: February 8, 2006)
500
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00289874
Other Study ID Numbers  ICMJE 0476-336
2006_001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date January 2016

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