Status:
COMPLETED
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 18 2006
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00398151
Start Date
August 1 2005
End Date
January 18 2006
Last Update
August 15 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.