A factorial randomised placebo controlled double-blind trial to evaluate Efficacy and safety of adding ASpirin plus omEga-3 and colchicine as repurposed treatments to enhance COPD exacerbation resolution and reduce recurrent exacerbations (EASE-COPD)
Chronic obstructive pulmonary disease (COPD)
2x2 factorial design trial. Participants will be randomised to of the following: 1. Aspirin 75mg with 1g omega-3 once daily; +placebo colchicine 500mcg every other day (alternate days) for 12 weeks. 2. Colchicine 500mcg every other day; + placebo aspirin 75mg with placebo 1g omega 3 once daily for 12 weeks. 3. Aspirin 75mg with 1g omega-3 once daily; +colchicine 500mcg every other day for 12 weeks 4. Placebo colchicine 500mcg every other day; + placebo aspirin 75mg with placebo 1g omega 3 once daily for 12 weeks. Sealed Envelope Ltd (https://www.sealedenvelope.com/) used for randomisation system.
1. Be willing and able to give consent to participate 2. Individuals with a COPD exacerbation 3. Aged 40 years and older 4. In the Investigator’s opinion, willing and able to comply with trial requirements
1. Inability to take the trial medication 2. Allergy or unsuitable for trial medications, including hypersensitivity or allergy to any of the trial drugs: aspirin, colchicine, omega-3, salicylic acid compounds, or prostaglandin synthetase inhibitors or excipients (including allergy to peanuts or soya \[lecithin], gelatine, glycerol, fish). Please see Trial Procedures Manual (TPM) for full list of excipients 3. Diagnosis of aspirin/NSAID-induced asthma (diagnosis of asthma itself is not an exclusion criterion) 4. Patients diagnosed with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, as medicine contains lactose 5. Already taking aspirin and/or colchicine, antiplatelets^, warfarin; concurrent treatment with systemic oral carbonic anhydrase inhibitors (acetazolamide), oral uricosuric drugs (e.g., probenecid, sulfinpyrazone), P-glycoprotein (P-gp) inhibitors or moderate-strong CYP 3A4 inhibitors (macrolides, diltiazem, verapamil, azoles, ritonavir, ciclosporin), methotrexate use (>15 mg/week). 6. Women of childbearing potential (WoCBP)+, unless using effective measures of contraception; pregnancy, planned pregnancy during the trial (52 weeks), breastfeeding 7. Any medical history or clinically relevant abnormality that makes the patient ineligible for inclusion in the trial because of a safety concern relating to participating in the trial or trial medications 8. Progressive neuromuscular disorder, myositis, myopathy, raised CK on statins 9. Participant with life expectancy of less than 3 months 10. Known immunocompromise, defined as a diagnosed immunodeficiency disorder (e.g., HIV-1 or HIV-2) or regular use of systemic immunosuppressive therapy (excluding physiologic replacement doses of hydrocortisone or prednisolone for adrenal insufficiency, which are permitted) 11. Clinically significant renal impairment, including haemodialysis or filtration use, eGFR <50 ml/min and/or serum creatinine >150