To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00398151
- Lead Sponsor
- Organon and Co
- Brief Summary
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
- Secondary Outcome Measures
Name Time Method Asthma symptoms score throughout the study