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

Organon

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: montelukast sodium; Drug: Comparator: Placebo (unspecified)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00337675

0476-302

2006_015

MK0476-302

Details and patient eligibility

About

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).

Enrollment: 1,771 patients

Sex: All

Ages: 6 months to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,771 participants in 3 patient groups, including a placebo group

Arm 1: drug + episodic supplemental placebo

Active Comparator group

Description:

Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period

Treatment:

Drug: montelukast sodium

Drug: montelukast sodium

Arm 2: placebo comparator + episodic supplemental drug

Active Comparator group

Description:

Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period

Treatment:

Drug: montelukast sodium

Drug: montelukast sodium

Arm 3: placebo comparator + episodic supplemental placebo

Placebo Comparator group

Description:

Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period

Treatment:

Drug: Comparator: Placebo (unspecified)