Status:
COMPLETED
Effect of Montelukast on the Airway Remodeling
Lead Sponsor:
Chinese Academy of Medical Sciences
Conditions:
Asthma
Eligibility:
All Genders
16-65 years
Phase:
PHASE4
Brief Summary
The distal lung contributes to asthmatic airway remodeling which is observed from early onset of the disease. Cysteinyl leukotrienes (CysLT) play important role in the pathogenesis of airway remodelin...
Detailed Description
Accumulated data have suggested that the distal lung, which includes airways of \< 2mm in diameter and lung parenchyma, contribute to asthma pathogenesis and symptoms. In addition to persisting inflam...
Eligibility Criteria
Inclusion
- forced expiratory volume in one second (FEV1) is at 60-80% predicted or less than 60% predicted
- clinical diagnosis of moderate-to-severe asthma.
Exclusion
- intravenous, oral or intramuscular steroids used within 1 months
- Anti-leukotrienes, cromolyn sodium or nedocromil used within 2 months
- Theophylline or beta-adrenergic blockers used within 1 month
- Tobacco Used within the past year or cumulative smoking history \> 5 pack-yrs
- Respiratory infection or an influenza vaccination Within 3 weeks
- Pregnant or lactating females
- Patient has a history of an anaphylactic allergic reaction related to administration of either a marketed or investigational drug
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00699062
Start Date
January 1 2010
End Date
January 1 2012
Last Update
January 5 2012
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China, 100730