Chronic obstructive pulmonary disease Respiratory
Conditions
Interventions
For randomisation, the trialists will use randomisation lists independently developed by their in-house biostatisticians. Participants will be stratified according to the recruiting hospital and setti
Sponsors
Manchester University NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males or females aged > 40 years 2. With a smoking history of at least 10 pack-years 3. A previous clinical diagnosis of COPD 4. Presenting with a moderate or severe AECOPD 5. Not having received antibiotics or systemic steroids during the preceding two weeks. 6. Capable of giving an informed consent 7. Subjects who are willing to allow his/her general practitioner, to be notified of their participation in the study. 8. The study will define severe exacerbations as those requiring hospitalisation, based on NICE criteria and moderate as those requiring antibiotics and/or systemic steroids, but not hospitalisation, according to the judgement of the responsible clinician who will be unaware of procalcitonin and EOS levels (following NICE guidelines)
Exclusion criteria
Exclusion criteria: 1. Patients who have already received antibiotics or systemic steroids during the 2 weeks preceding recruitment/randomisation to the TRACE-COPD study 2. Those presenting with decompensated type 2 respiratory failure, requiring non-invasive ventilation and those admitted to the intensive care unit upon presentation 3. Patients with a primary diagnosis of pneumonia 4. Patients with a current diagnosis of asthma 5. Patients with known immunodeficiencies, cystic fibrosis, active tuberculosis, clinically significant bronchiectasis, those receiving long-term antibiotics and those with life expectancy of less than a year 6. People not able or keen to provide an informed consent for the study 7. Female participants who are pregnant or lactating 8. Patients diagnosed with medullary thyroid carcinoma (as this secretes procalcitonin) 9. Participants in active clinical trials of investigational medicinal products (IMP) or people who participated in clinical trials of IMP during the preceding 6 months. We will not recruit patients participating in any trial on COPD exacerbations 10. Patients with known allergy or sensitivity to doxycycline or prednisolone or an absolute contra-indication to their use 11. Patients in active clinical trials of investigational medicinal products (IMP) or people who participated in clinical trials of IMP during the preceding 6 months 12. Patients participating in any trial on COPD exacerbtaions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of patients receiving antibiotics for the index exacerbation, evaluated between day 14-21 2. The proportion of patients receiving systemic steroids for the index exacerbation, evaluated between day 14-21 3. Acceptability of the intervention (qualitative data collected throughout the study and during focus group meetings with participants), recruitment and consent rate (evaluated at baseline) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment failure at day 14. Treatment failure will be defined as lack of treatment success, significant symptoms deterioration leading to unplanned healthcare utilisation, or the clinical need for administration of additional antibiotics and/or systemic corticosteroids, or death by day 14 2. Time-to-treatment success, evaluated at day 14-21. Treatment success will be defined as the first day of three consecutive days when the patient will have returned to his normal health state or the first of seven consecutive days in which the patient will only report minor increase in symptoms compared to baseline, without fever or altered sputum color 3. Re-exacerbation rate and re-hospitalisation rate at 6 months 4. Mortality during the index exacerbation (before treatment success, to be evaluated between day 14-21) and at 6 months 5. Adverse events and serious adverse events, evaluated at day 14 6. Increased length of admission or (re-)admission due to side effects to study medications, evaluated at day 14-21 7. Adherence to the intervention by clinicians and patients, evaluated at day 14-21 8. The proportion of patients testing negative to both biomarkers (evaluated at baseline) and the safety of the intervention in this subgroup [see secondary outcomes 1-4] 9. Sample size for a future confirmatory trial, evaluated at day 14-21 10. Feasibility and challenges of community recruitment of patients with acute exacerbations of COPD, evaluated at baseline 11. Resources required for a future, confirmatory trial, including clinic rooms, time investment in the progamme by the study clinicians, evaluated at 6 months 12. Researchers’ and participants’ feedback on the study experience, challenges in the conduction of the study and selected outcomes, collected throughout recruitment 13. Systemic | — |
Countries
United Kingdom
Contacts
Public ContactKaren Rhodes
Outcome results
None listed