First Step With Singulair® Therapy - Full Text View

First Step With Singulair® Therapy (FIRST)

This study has been completed.

First Received: October 16, 2007 Last Updated: October 19, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00545324

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment
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:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Canadian asthma guidelines criteria

Secondary Outcome Measures:

Asthma control questionnaire

Estimated Enrollment:	435
Study Start Date:	September 2002

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 &micro g/day flovent® or equivalent per day)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545324

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

(MedWatch - FDA maintained medical product safety Information) This link exits the ClinicalTrials.gov site

(PhRMA Clinical Study Results Database - web-based repository for clinical study results) This link exits the ClinicalTrials.gov site

(Merck: Patient & Caregiver U.S. Product Web Site) This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	2007_025
Study First Received:	October 16, 2007
Last Updated:	October 19, 2007
ClinicalTrials.gov Identifier:	NCT00545324 History of Changes
Health Authority:	Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Montelukast
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 20, 2009