To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy

This study has been completed.

First Received: November 9, 2006 Last Updated: February 2, 2007 History of Changes

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00398151

Purpose

To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.

Condition	Intervention	Phase
Asthma	Drug: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy

Resource links provided by NLM:

MedlinePlus related topics: Asthma Urine and Urination

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy

Secondary Outcome Measures:

Asthma symptoms score throughout the study

Estimated Enrollment:	50
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Allergic rhinints symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
Male or female outpatient 20 years of age and older
Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria:

Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
Treated with montelukast within 3 months before enrollment
Unable to perform acceptable, reproducible spirometry and peak flow measurement
Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398151

Locations

Taiwan
Merck Sharp & Dohme (I.A.) Corp.
Taipei, Taiwan, 106

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Study ID Numbers:	2006_043
Study First Received:	November 9, 2006
Last Updated:	February 2, 2007
ClinicalTrials.gov Identifier:	NCT00398151 History of Changes
Health Authority:	Taiwan: National Bureau of Controlled Drugs

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 08, 2010