COPD II-III MedDRA version: 13.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: ASS Genericon 500 mg
Product Code: ASA
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Medical University of Vienna, Department of Clinical Pharmacology
Eligibility
Sex/Gender
All
Inclusion criteria
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: =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of ASA as add-on therapy in COPD patients in comparison to placebo in spirometric and clinical regard, and to evaluate safety of this therapy.;Secondary Objective: safety;Primary end point(s): Changes (d) in FEV1 after 12 weeks of study medication compared to baseline. Post-bronchodilatator FEV1 will be measured between 0 and 8 hours after last dose of study medication. FEV1 will be measured always in the morning between 08:00 and 10:30 a.m. | — |
Countries
Austria
Outcome results
None listed