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

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

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

Study placed in the following topic categories:

Montelukast

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Asthma

Rhinitis

Leukotriene Antagonists

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Immune System Diseases

Bronchial Diseases

Therapeutic Uses

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

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