Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease
Status:
Unknown status
Trial end date:
2013-06-01
Target enrollment:
Participant gender:
Summary
The pathomechanisms of COPD are still not fully understood, and up to now there is no
satisfying causal treatment inhibiting the progress of the disease. Available therapy is in
most cases symptomatic. Experimental and clinical observations suggest that treatment with
ASA might be beneficial in the treatment of COPD in terms of respiratory and lung-functional
improvement.
To evaluate the efficacy of ASA as add-on therapy in COPD in comparison to placebo a
prospective, randomized, double-blind, placebo controlled study will be conducted. Adult male
and female patients (n=74) with proven COPD GOLD grade II-III will be randomized to 2 groups
(i.e. 37 patients per group, stratification according to smoking status and gender). They
will receive either 500 mg ASA per day or matching placebo over 12 weeks. Primary efficacy
endpoints are changes in the lung-functional parameter FEV1 (forced expiratory 1-second
volume) after 12 weeks of treatment. Secondary endpoints are the health score of the St.
Georges respiratory questionnaire (SGRQ) and Peak-flow (PEF).