Asthma
Conditions
Brief summary
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
Interventions
DRUGMK0476, montelukast sodium / Duration of Treatment: 12 Weeks
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Asthma symptoms score throughout the study | — |
Outcome results
None listed