OPACE (CPMS: 55548 / IRAS: 1006202)

UPDATED - 21/08/2025

A randomised parallel 2-arm double-blinded non-inferiority adaptive design pragmatic trial to evaluate the clinical effectiveness of stopping azithromycin chemoprophylaxis completely 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:

1. Be able and willing to provide informed consent.

2. Have an established clinical diagnosis of COPD and received prophylactic long term azithromycin (or equivalent macrolide*) for ≥ (at least) 3 months in the past 12 months to reduce COPD exacerbations.

3. Have a self-reported smoking history.

4. Be aged >= 40 years.

5. Have clinically stable COPD, i.e. no COPD exacerbation for at least 4 weeks. 

*Equivalent macrolide - these participants would need to be established on open label/routine prescription of azithromycin for at least 4 weeks before randomisation.

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:

1. 1. Known hypersensitivity or allergy to any of the trial drugs or excipients (e.g. known allergic reaction/hypersensitivity to tartrazine*, known allergic reaction to aspirin**, or known diagnosis of aspirin induced asthma; see the TPM).

   2. Current breast feeding, pregnancy or planned pregnancy during the trial.

   3. 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.

   4. Known immunodeficiency requiring immunoglobulin/specific antibody therapy.

   5. Azithromycin (or equivalent macrolide) prophylaxis prescribed for non-COPD condition.

   6. Active participation in COPD CTIMP.

*Tartrazine (E102) is used as a colourant and added to many foods, medications and vitamins. Because of short supply in the UK/Europe, azithromycin sourced from USA where azithromycin tablets are red in colour. Known hypersensitivity/allergic reaction to this food colourant (tartrazine) or known allergic reaction to aspirin, or known diagnosis of aspirin induced asthma (due to potential cross-reactivity with tartrazine allergy) are exclusion criteria.

**Contraindication or inability have aspirin due to any other reason bar an allergic reaction to aspirin (i.e aspirin intolerance and contraindication due to its side effects of risk of bleeding, gastrointestinal effects for example), are NOT exclusion criteria for the trial. Asthma (besides specifically confirmed diagnosis of aspirin induced asthma) are NOT exclusion criteria for the trial, see the TPM.

Study Resources

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Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

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