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

June 14, 2006
March 6, 2014
October 2006
August 2009   (final data collection date for primary outcome measure)
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.
Number of asthma episodes culminating in asthma attack
Complete list of historical versions of study NCT00337675 on ClinicalTrials.gov Archive Site
  • 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.
Respiratory symptoms, safety and tolerability
Not Provided
Not Provided
 
Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)
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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • 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®
  • 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.
    Other Names:
    • MK0476
    • Singulair®
  • 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
    Intervention: Drug: montelukast sodium
  • 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
    Intervention: Drug: montelukast sodium
  • 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
    Intervention: Drug: Comparator: Placebo (unspecified)
Valovirta E,Boza ML,Robertson CF,Verbruggen N,Smugar SS,Nelsen LM,Knorr BA,Reiss TF,Philip G,Gurner DM . Intermittent or daily montelukast versus placebo for episodic asthma in children. . Ann Allergy Asthma Immunol . 2011 Jun;106(6):518-26. PMID: 21624752

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1771
August 2009
August 2009   (final data collection date for primary outcome measure)

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)
Both
6 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00337675
0476-302, MK0476-302, 2006_015
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2014

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