To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

Sponsor

Organon and Co (Industry)

Overall Status

Completed

CT.gov ID

NCT00398151

Collaborator

(none)

Enrollment

5.6

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy

Actual Study Start Date :

Aug 1, 2005

Actual Primary Completion Date :

Jan 18, 2006

Actual Study Completion Date :

Jan 18, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Allergic rhinitis 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

Locations

No locations specified.

Sponsors and Collaborators

Organon and Co

Investigators

Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Organon and Co

ClinicalTrials.gov Identifier:

NCT00398151

Other Study ID Numbers:

0476-366
2006_043

First Posted:

Nov 10, 2006

Last Update Posted:

Feb 14, 2022

Last Verified:

Jan 1, 2022

Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022