SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen (0476-363) (STAR)

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: March 6, 2007
Last updated: October 9, 2015
Last verified: October 2015
The purpose of this study is to assess the treatment effect of montelukast 10mg on the primary endpoint of Asthma Control Questionnaire(ACQ), over a 8-week period, in persistent asthma patients with or without allergic rhinitis.

Condition Intervention Phase
Drug: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Observational Study to Assess The Efficacy, Safety and Tolerability of Added Singulair in Persistent Asthma Patients With or Without Allergic Rhinitis and Long Acting B-Agonist

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Change of the asthma control questionnaire scores taken over 8 weeks

Enrollment: 198
Study Start Date: November 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   15 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient is currently a nonsmoker and has been a nonsmoker for at least 1 year
  • Patient with clinical evidence of mild/moderate asthma with or without allergic rhinitis

Exclusion Criteria:

  • Patient has been treated in an emergency room for asthma within 4 weeks or has been hospitalized for asthma within 3 months prior to visit 1
  • Patient with severe asthma, upper respiratory infection, sinusitis, infectious rhinitis, non-allergic rhinitis
  • Patient has any active, acute, or chronic pulmonary disorder that is documented by history, physical examination
  Contacts and Locations
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Please refer to this study by its identifier: NCT00445107

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00445107     History of Changes
Other Study ID Numbers: 0476-363  2007_002 
Study First Received: March 6, 2007
Last Updated: October 9, 2015
Health Authority: Korea: Food and Drug Administration

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 01, 2016