First Step With Singulair® Therapy (0476-323)

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

Comparator: Fluticasone / Duration of Treatment: 6 Weeks

Drug

Primary outcomes

Canadian asthma guidelines criteria

Secondary outcomes

Asthma control questionnaire

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

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

Acronym: FIRST

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Oct 17, 2007
Registry last updated: Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed