First Step With Singulair® Therapy
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks (Drug); Comparator: Fluticasone / Duration of Treatment: 6 Weeks (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: Canadian asthma guidelines criteria
Secondary outcome: Asthma control questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
(MedWatch - FDA maintained medical product safety Information) (PhRMA Clinical Study Results Database - web-based repository for clinical study results) (Merck: Patient & Caregiver U.S. Product Web Site)
Starting date: September 2002
Last updated: October 19, 2007
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