First Step With Singulair® Therapy (0476-323)

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00545324

Acronym

FIRST

Enrollment

399

Registered

2007-10-17

Start date

2002-09-30

Completion date

2003-12-31

Last updated

2024-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

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.

Interventions

DRUGMK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks

DRUGComparator: Fluticasone / Duration of Treatment: 6 Weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Canadian asthma guidelines criteria	—

Secondary

Measure	Time frame
Asthma control questionnaire	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026