Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (ASA-COPD)
Primary Purpose
COPD
Status
Unknown status
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Acetylsalicylic acid
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
- COPD GOLD II or III
Exclusion Criteria:
- Long term NSAIDS, pregnancy et al.
Sites / Locations
- Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ASA
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment
lung functional testing
Secondary Outcome Measures
Full Information
NCT ID
NCT01328145
First Posted
March 29, 2011
Last Updated
December 24, 2012
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01328145
Brief Title
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease
Acronym
ASA-COPD
Official Title
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ASA
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Intervention Description
500 mg /day
Primary Outcome Measure Information:
Title
Change in FEV1 (forced expiratory volume in 1 second) after 12 weeks of treatment
Description
lung functional testing
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD GOLD II or III
Exclusion Criteria:
Long term NSAIDS, pregnancy et al.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Sauermann, MD
Phone
00431404002981
Email
robert.sauermann@meduniwien.ac.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Ziesche, MD, Professor
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Sauermann, md
12. IPD Sharing Statement
Learn more about this trial
Acetylic Salicylic Acid for the Treatment of Chronic Obstructive Pulmonary Disease
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