Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease
- Registration Number
- NCT01328145
- Lead Sponsor
- Medical University of Vienna
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 74
- COPD GOLD II or III
- Long term NSAIDS, pregnancy et al.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ASA Acetylsalicylic acid - Placebo Acetylsalicylic acid -
- Primary Outcome Measures
Name Time Method Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment 12 weeks lung functional testing
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical University of Vienna
🇦🇹Vienna, Austria