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ABACOPD

ABACOPD

 

ABACOPD is a randomized double blind placebo-controlled study to demonstrate that antibiotics are not needed in mild to moderate acute exacerbations of COPD.

 

Multicenter Study (Germany)

Approx. 25 centres

 

Condition:

Chronic obstructive pulmonary disease (COPD)

 

Objectives:

 

The aim oh the clinical study is to demonstrate, that there is no relevant increase in the “failure-rate” for patients treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as an immediate treatment failure if additional antibiotic therapy is required during the treatment period or until the test of cure visit (primary endpoint).

Design:

Phase IV randomized double blind placebo-controlled multi-centre clinical trial

 

Population:

  • Adults older than 40 years of age
  • with a smoking history of 10 Pack Years or more
  • Diagnosed with COPD stages I-IV 
  • with mild to moderate acute exacerbation of COPD
  • defined by a sustained worsening of the patient’s condition (including at least 2 of the following symptoms: increased dyspnea, sputum production, and sputum purulence)
  • from the stable state and beyond normal day-to-day variations
  • necessitating a change in regular medication in a patient with underlying COPD
  • which the patient  can manage in his/her normal environment or with the help of additional medical assistance without need for intermediate or intensive care.


Patients: