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CompletedNCT00545324FIRSTUpdated Aug 15, 2024

First Step With Singulair® Therapy (0476-323)

A Phase 4 interventional study of MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks and Comparator: Fluticasone / Duration of Treatment: 6 Weeks in Asthma, sponsored by Organon and Co. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Organon and Co · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
399
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 399 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
399 participants (actual)

Interventions

  • DrugMK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks
  • DrugComparator: Fluticasone / Duration of Treatment: 6 Weeks
06

What researchers measure

Primary outcomes

  1. Canadian asthma guidelines criteria

Secondary outcomes

  1. Asthma control questionnaire

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00545324
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Oct 17, 2007
Start date
Sep 2002
Primary completion
Dec 2003
Completion
Dec 2003
Last update
Aug 15, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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