First Step With Singulair® Therapy (0476-323) (FIRST)

A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma "To Low Dose" Inhaled Corticosteroid Treatment

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks; Drug: Comparator: Fluticasone / Duration of Treatment: 6 Weeks

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 µ g/day flovent® or equivalent per day)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Canadian asthma guidelines criteria

Secondary Outcome Measures

Outcome Measure
Asthma control questionnaire

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): December 1, 2003
• Study Completion (Actual): December 1, 2003

Study Registration Dates

• First Submitted: October 16, 2007
• First Submitted That Met QC Criteria: October 16, 2007
• First Posted (Estimate): October 17, 2007

Study Record Updates

• Last Update Posted (Actual): February 14, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Montelukast; Fluticasone
• Other Study ID Numbers: 0476-323; 2007_025

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis