Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337675
First received: June 14, 2006
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection).


Condition Intervention Phase
Asthma
Drug: montelukast sodium
Drug: Comparator: Placebo (unspecified)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period [ Time Frame: 1-year treatment period ] [ Designated as safety issue: No ]
    The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.


Secondary Outcome Measures:
  • Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.

  • Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.


Enrollment: 1771
Study Start Date: October 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1: drug + episodic supplemental placebo
Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
Drug: montelukast sodium
Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Other Names:
  • MK0476
  • Singulair®
Active Comparator: Arm 2: placebo comparator + episodic supplemental drug
Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period
Drug: montelukast sodium
Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.
Other Names:
  • MK0476
  • Singulair®
Placebo Comparator: Arm 3: placebo comparator + episodic supplemental placebo
Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
Drug: Comparator: Placebo (unspecified)
Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 6 months to 5 years with episodic (periodic) asthma

Exclusion Criteria:

  • Patients who are not in otherwise good health
  • Patients who have persistent asthma (continual asthma symptoms)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00337675

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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00337675     History of Changes
Other Study ID Numbers: 0476-302, MK0476-302, 2006_015
Study First Received: June 14, 2006
Results First Received: February 19, 2010
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System 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 23, 2014