SINGULAIR (R) as Complementary Therapy to Fixed Association Regimen - Full Text View

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

This study has been completed.

First Received: March 6, 2007 No Changes Posted

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00445107

Purpose

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
Asthma	Drug: MK0476, montelukast sodium / Duration of Treatment: 8 Weeks	Phase III

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Change of the asthma control questionnaire scores taken over 8 weeks

Estimated Enrollment:	198
Study Start Date:	November 2005

Eligibility

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445107

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2007_002
Study First Received:	March 6, 2007
Last Updated:	March 6, 2007
ClinicalTrials.gov Identifier:	NCT00445107 History of Changes
Health Authority:	Korea: Food and Drug Administration

Study placed in the following topic categories:

Bronchial Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Rhinitis
Hormones
Leukotriene Antagonists

Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Asthma
Pharmacologic Actions

Leukotriene Antagonists
Montelukast
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on May 06, 2009