Effect of Montelukast on the Airway Remodeling

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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 remodeling and antileukotrienes work to exert a certain degree of anti-inflammatory effect. The cysteinyl leukotriene antagonist Montelukast has been in vivo shown to significantly inhibit ovalbumin induced airway smooth muscle hyperplasia and subepithelial fibrosis in sensitized mice. This study aims to evaluate if Montelukast could reverse airway remodeling in asthma patients by a non-invasive approach-HRCT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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