First Step With Singulair® Therapy (FIRST)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00545324
First received: October 16, 2007
Last updated: October 19, 2007
Last verified: October 2007
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Purpose
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 |
---|---|---|
Asthma |
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:
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
More Information
Additional Information:
No publications provided
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Additional Information:
No publications provided
ClinicalTrials.gov Identifier: | NCT00545324 History of Changes |
Other Study ID Numbers: | 2007_025 |
Study First Received: | October 16, 2007 |
Last Updated: | October 19, 2007 |
Health Authority: | Canada: Canadian Institutes of Health Research |
Additional relevant MeSH terms:
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Montelukast Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Leukotriene Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on October 17, 2012