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

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ClinicalTrials.gov Identifier: NCT01328145
Recruitment Status : Unknown
Verified December 2012 by Rolf Ziesche, Medical University of Vienna.
Recruitment status was:  Recruiting
First Posted : April 4, 2011
Last Update Posted : December 25, 2012
Information provided by (Responsible Party):
Rolf Ziesche, 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).

Condition or disease Intervention/treatment Phase
COPD Drug: Acetylsalicylic acid Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : April 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: ASA Drug: Acetylsalicylic acid
500 mg /day
Placebo Comparator: Placebo Drug: Acetylsalicylic acid
500 mg /day

Primary Outcome Measures :
  1. Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment [ Time Frame: 12 weeks ]
    lung functional testing

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:


Exclusion Criteria:

  • Long term NSAIDS, pregnancy et al.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328145

Contact: Robert Sauermann, MD 00431404002981 robert.sauermann@meduniwien.ac.at

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

Responsible Party: Rolf Ziesche, Professor, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01328145     History of Changes
Other Study ID Numbers: 2010-022123-29
First Posted: April 4, 2011    Key Record Dates
Last Update Posted: December 25, 2012
Last Verified: December 2012

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