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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: October 16, 2007
Last updated: March 11, 2015
Last verified: March 2015
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.

Condition Intervention Phase
Drug: MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks
Drug: Comparator: Fluticasone / Duration of Treatment: 6 Weeks
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Canadian asthma guidelines criteria

Secondary Outcome Measures:
  • Asthma control questionnaire

Enrollment: 399
Study Start Date: September 2002
Study Completion Date: December 2003
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • 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&reg; or equivalent per day)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00545324

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00545324     History of Changes
Other Study ID Numbers: 0476-323  2007_025 
Study First Received: October 16, 2007
Last Updated: March 11, 2015
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses processed this record on May 05, 2016