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

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Tracking Information

• First Submitted Date: February 7, 2006
• First Posted Date: February 10, 2006
• Results First Submitted Date: September 9, 2009
• Results First Posted Date: October 1, 2010
• Last Update Posted Date: February 17, 2016
• Study Start Date: March 2006
• Actual Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: February 8, 2006): Percent change from baseline in Forced Expiratory Volume in 1 minute (FEV1)

Current Secondary Outcome Measures (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 (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: Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Asthma

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 10, 2010): 421
• Original Enrollment (submitted: February 8, 2006): 500
• Actual Study Completion Date: July 2007
• Actual Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 6 Years to 14 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00289874
• Other Study ID Numbers: 0476-336; 2006_001
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Merck Sharp & Dohme Corp.
• Study Sponsor: Merck Sharp & Dohme Corp.
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme Corp.

• PRS Account: Merck Sharp & Dohme Corp.
• Verification Date: January 2016