Acetylic salicylic acid for the treatment of Chronic Obstructive Pulmonary Disease (COPD). A randomized, double-blind, placebo-controlled trial - ASA-COPD

• Conditions: COPD II-III; MedDRA version: 13.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2010-022123-29-AT
• Lead Sponsor: Medical University of Vienna, Department of Clinical Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-15
• Last Update Posted: 17 March 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Signed informed consent prior to any study-mandated procedure.
•Male and female patients aged = 18 and = 75 yrs.
•Clinically and functionally proven COPD GOLD II-III (definition: COPD with postbronchodilatator FEV1/FVC: < 0.7; FEV1: < 80%, but =30% predicted; improvement of FEV1 after bronchodilatator = 12% AND = 200ml)
•AST and ALT values within three times upper limit of normal.
•Serum creatinine = 1.5 mg/dl.
•Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
•Negative pregnancy test in female patients of childbearing potential.
•Adequate contraception in female patients of childbearing age.
•Absence of acute bronchitis, active COPD exacerbation or relevant acute infection within 7 days before active study participation (start of PEF-baseline)
•Smoker or ex-smoker (minimum history of = 5 pack years)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Known hypersensitivity to ASA.
•Treatment with another investigational drug within 1 month prior to start of study medication.
?Other known severe cause of pulmonary disease like known active tuberculosis, systemic fungal infection, lymphoma, asthma, interstitial lung disease, significant pulmonary hypertension.
•Long term (> 2 months) administration of ASA or other NSAIDs within the past 2 years. This in-cludes low-dose ASA for prophylactic reasons.
(Allowed: Clopidogrel intake)
•Patients requiring therapeutic anticoagulation
•Malignancy requiring chemotherapy or radiation
•Uncontrolled other known disease like:
•Chronic heart failure NYHA III, IV
•Uncontrolled diabetes mellitus with a blood glucose 2x per day > 250 mg/dl (in the past week), or a HbA1c > 10 %
•Gastrointestinal ulcera or history of relevant gastrointestinal bleedings
•Severe renal or hepatic insufficiency
•Uncontrolled arterial hypertension (SBP > 180 mmHg)
•Current acute bronchitis, COPD exacerbation or relevant infection
•Are pregnant, nursing, or planning pregnancy during the trial or within three month period thereafter
•Have a known drug or alcohol abuse within 3 years of screening
•Presumed non-compliance.
•Known legal incapacity or limited legal capacity at screening
•Relevant coagulation disorders
•Planned relevant surgical interventions during study period
•Smoking history of less than 5 pack years during lifetime

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified