OPACE
OPACE (CPMS: 55548 / IRAS: 1006202)
UPDATED - 5 May 2023
A randomised parallel 3-arm double-blinded non-inferiority adaptive design pragmatic trial to evaluate the clinical effectiveness of stopping azithromycin chemoprophylaxis completely or over the summer vs continued treatment in people with COPD at high risk of exacerbations.
Inclusion & Exclusion Criteria
Inclusion criteria, potentially eligible to be invited to take part:
Be able and willing to provide informed consent.
Have an established clinical diagnosis of COPD and be receiving prophylactic
azithromycin for ≥ (at least) 3 months to reduce COPD exacerbations.
Have a self-reported smoking history of ≥ (at least) 10 pack years.
Be aged >= 40 years.
Have clinically stable COPD, i.e. no COPD exacerbation for at least 6 weeks.
Exclusion criteria, not to be invited to take part:
Electrocardiograms (ECGs) will not be a trial assessment nor entry requirement. The
presence of any of the following will preclude participant inclusion:
Known hypersensitivity to any of the trial drugs or excipients.
Current breast feeding, pregnancy or planned pregnancy during the trial.
Any medical history or clinically relevant abnormality that makes patient ineligible for
inclusion because of a safety concern relating to continuing or discontinuing
azithromycin or other considerations.
Known immunodeficiency requiring immunoglobulin/specific antibody therapy.
Azithromycin prophylaxis prescribed for non-COPD condition.
Active participation in COPD CTIMP. Active participation in COPD CTIMP.
Study Resources
Access for the SystmOne and EMIS study resources can be requested below.
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Disclaimer:
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