Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (ASA-COPD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2012 by Medical University of Vienna.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Rolf Ziesche, Medical University of Vienna Identifier:
First received: March 29, 2011
Last updated: December 24, 2012
Last verified: December 2012

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).

Condition Intervention Phase
Drug: Acetylsalicylic acid
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    lung functional testing

Estimated Enrollment: 74
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ASA Drug: Acetylsalicylic acid
500 mg /day
Placebo Comparator: Placebo Drug: Acetylsalicylic acid
500 mg /day


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:


Exclusion Criteria:

  • Long term NSAIDS, pregnancy et al.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01328145

Contact: Robert Sauermann, MD 00431404002981

Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Robert Sauermann, md         
Sponsors and Collaborators
Medical University of Vienna
Principal Investigator: Rolf Ziesche, MD, Professor Medical University of Vienna
  More Information

Responsible Party: Rolf Ziesche, Professor, Medical University of Vienna Identifier: NCT01328145     History of Changes
Other Study ID Numbers: 2010-022123-29 
Study First Received: March 29, 2011
Last Updated: December 24, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Salicylic Acid
Analgesics, Non-Narcotic
Anti-Infective Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antifungal Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Dermatologic Agents
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Keratolytic Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Sensory System Agents processed this record on May 26, 2016