First Step With Singulair® Therapy (0476-323)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

399 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2003-12-31

Brief Summary

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In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks

Intervention Type DRUG

Comparator: Fluticasone / Duration of Treatment: 6 Weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
* Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
* Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
* Patient's forced expiratory volume in one second (fev1) is \< 80% of predicted value

Exclusion Criteria

* Patient on combination therapy
* Patient on long acting beta2 agonists
* Patient on using moderate to high doses of ICS. (ICS \>250 \&micro g/day flovent\® or equivalent per day)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No