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

This study is currently recruiting participants.
Verified December 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Rolf Ziesche, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01328145
First received: March 29, 2011
Last updated: December 24, 2012
Last verified: December 2012
  Purpose

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
COPD
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

  Eligibility

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

Inclusion Criteria:

  • COPD GOLD II or III

Exclusion Criteria:

  • Long term NSAIDS, pregnancy et al.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01328145

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

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

No publications provided

Responsible Party: Rolf Ziesche, Professor, Medical University of Vienna
ClinicalTrials.gov 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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Aspirin
Salicylates
Salicylic Acid
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents

ClinicalTrials.gov processed this record on April 16, 2014