The Project

ABACOPD Study

Randomised double blind placebo-controlled study to demonstrate that antibiotics are not needed in mild to moderate acute exacerbations of COPD – The ABACOPD Study

Multicenter Study (Germany)

Condition
Chronic obstructive pulmonary disease (COPD)

Objectives

Primary objective:
To demonstrate in a clinical study 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).

Secondary objectives:

  • To evaluate long-term consequences of Placebo treatment
- Relapse rate at late follow-up (LFU-3; 1 year)
- Time to relapse
  • To assess patient’s clinical improvement relative to treatment
- Clinical cure rate at the EOT visit
- Clinical cure rate at the TOC visit (both determined by patient-centred outcomes (diary cards)
  • To assess additional efficacy endpoints and health outcome evaluations following 5 days treatment with either placebo or oral sultamicillin with either treatment used as a supplement to the standard of care for patients with acute exacerbations of COPD:
- Changes in the Clinical COPD Questionnaire (in cooperation with T. van der Molen)
- Changes in COPD Assessment Test (CAT, in cooperation with P. Jones)
- Additional antibiotic therapy
- Time to next exacerbation
- Number of exacerbations during follow up
- Per-subject relapse rate at the LFU visit in the subset of subjects in the CE population who were clinically cured at the TOC visit
- Changes in length of stay in hospital for hospitalised patients
- Changes in biomarkers (CRP, Procalcitonin etc.)
- All cause mortality  

 

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 as defined by the Global initiative for chronic Obstructive Lung Disease (GOLD) presenting 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.

Sample size
Approximately 980 patients will be enrolled, with the goal of obtaining 480 clinically evaluable patients per treatment arm.

Number of Centres

Approximately 25 centres

Treatments

Oral sultamicillin, 750 mg twice daily for 5 days or
Placebo twice daily for 5 days
In addition, patients will receive treatment required care for COPD exacerbations (including a standard regimen of oral corticosteroids).