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NCT00398151 Clinical Trial

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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00398151
Other study ID # 0476-366
Secondary ID 2006_043
Status Completed
Phase Phase 3
First received
Last updated
Start date August 1, 2005
Est. completion date January 18, 2006

Study information
Verified date January 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 58
Est. completion date January 18, 2006
Est. primary completion date January 18, 2006
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0476, montelukast sodium / Duration of Treatment: 12 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

Outcome
Type Measure Description Time frame Safety issue
Primary Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
Secondary Asthma symptoms score throughout the study
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