To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: MK0476, montelukast sodium / Duration of Treatment: 12 Weeks (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from
peripheral blood after newly initiated montelukast therapy.
Clinical Details
Official title: An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
Secondary outcome: Asthma symptoms score throughout the study
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Allergic rhinints 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
Locations and Contacts
Merck Sharp & Dohme (I.A.) Corp., Taipei 106, Taiwan
Additional Information
Starting date: August 2005
Last updated: February 2, 2007
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