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

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).

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Drug: Acetylsalicylic acid

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Robert Sauermann, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD GOLD II or III

Exclusion Criteria:

• Long term NSAIDS, pregnancy et al.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Acetylsalicylic acid; 500 mg /day
Active Comparator: ASA	Drug: Acetylsalicylic acid; 500 mg /day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment	lung functional testing	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Rolf Ziesche, MD, Professor, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: April 1, 2011
• First Posted (Estimate): April 4, 2011

Study Record Updates

• Last Update Posted (Estimate): December 25, 2012
• Last Update Submitted That Met QC Criteria: December 24, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: 2010-022123-29