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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00545324
First received: October 16, 2007
Last updated: May 24, 2013
Last verified: May 2013
  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 Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Canadian asthma guidelines criteria

Secondary Outcome Measures:
  • Asthma control questionnaire

Estimated Enrollment: 435
Study Start Date: September 2002
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  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&reg; or equivalent per day)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545324

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

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: May 24, 2013
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 April 21, 2014