Intermittent and Daily Dosing for Episodic (Periodic) Asthma

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).

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 1 to 5 Years

Conditions

Asthma

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Details

Primary Outcome Measures:

• Number of asthma episodes culminating in asthma attack over the 1-year treatment period [Time Frame: 1-year treatment period]

Secondary Outcome Measures:

• Respiratory symptoms, safety and tolerability over the 1-year treatment period [Time Frame: 1-year treatment period]

Study Start

August 2006

Eligibility & Criteria

• Ages Eligible for Study: 1 Year – 5 Years
• Genders Eligible for Study: Both

Inclusion Criteria:

• Patients aged 1 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)

Total Enrolment

1350

Contact Details

Merck Sharp & Dohme (Australia) Inc., South Granville, NSW 2142, Australia; Recruiting

• David Woolner 61-2-9795-9500