Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
The ultimate goal is to reduce unnecessary antibiotic prescriptions which drive the development of antibiotic resistance in the community. The primary objective of ABACOPD is to demonstrate in a sufficiently sized clinical study that there is no relevant increase in the "failure-rate" for patients with acute moderate exacerbations of COPD (AE-COPD) treated with placebo instead of antibiotic treatment both on top of standard of care. A patient is classified as treatment failure if additional antibiotic therapy is required during treatment period or until the test of cure visit (TOC at day 30, primary endpoint).
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Adults, either sex, older or equal than 40 years of age
For female patients, the following conditions are to be met:
has been postmenopausal for at least 1 year, or
is surgically incapable of bearing children, or
is of childbearing potential, and the following conditions are met:
Patients diagnosed with COPD stages I-IV as defined by the Global initiative for chronic Obstructive Lung disease (GOLD).
and
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
295 participants in 2 patient groups, including a placebo group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal