Intermittent and Daily Dosing for Episodic (Periodic) Asthma

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”

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).

Intervention(s) in this Clinical Trial

• 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.
• Drug: Comparator: Placebo (unspecified)
  • Placebo (Pbo) qd + episode driven supplemental Pbo 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.

Arms, Groups and Cohorts in this Clinical Trial

• 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
• 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
• 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

Primary Measures

• Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
  • Time Frame: 1-year treatment period
    Safety Issue?: No

Secondary 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
    Safety Issue?: No
• 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
    Safety Issue?: No

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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Months

Maximum Age for this Clinical Trial: 5 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Merck Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00337675

Study ID Number: 2006_015

ClinicalTrials.gov Identifier: NCT00337675

Health Authority: United States: Food and Drug Administration

(MedWatch - FDA maintained medical product safety Information)

(Merck: Patient & Caregiver U.S. Product Web Site)