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

• Status: Completed
• Trial end date: 2006-01-18
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

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