COPD Clinical Trial
Official title:
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A Randomized, Double-blind, Placebo-controlled Trial
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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