Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) Respiratory Chronic obstructive pulmonary disease
Conditions
Interventions
Current interventions as of 21/02/2017:
PACE will assess the use of a CRP POCT to guide antibiotic treatment decisions for patients presenting in primary care with AECOPD. Patients randomised to the i
Sponsors
Cardiff University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 21/02/2017: 1. Has a current acute exacerbation [presenting with at least one of the following: Increased dyspnoea, increased sputum volume, increased sputum purulence] that has lasted for at least 24 hours and no longer than 21 days 2. Diagnosis of COPD in clinical record/on COPD Practice register 3. Age 40 years or more 4. Able to provide informed consent 5. Patient should be able to provide the primary outcome data at 2 and 4 weeks within the expected windows Previous inclusion criteria: 1. Adults aged 40 2. Spirometry confirmed (at any time point prior to admission) COPD (post bronchodilator FEV1/FVC < 0.7) 3. Patients with mild, moderate and severe disease: that is FEV1 of more than 30% of the predicted value as indicated by the age and the height of the person (GOLD stage 1-3) 4. Have a current AECOPD, defined as, ?an event in the natural course of the disease characterized by a change in the patient's baseline dyspnoea, cough and/or sputum that is beyond normal day-to-day variations, is acute in onset and may warrant a change in regular medication? 5. The exacerbation has lasted for at least 24 hours but equal to or less than 21 days 6. Are able to attend the GP surgery 7. Are able to provide informed consent and complete study procedures.
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 21/02/2017: 1. The responsible GP feels urgent referral to hospital is necessary 2. Severe illness (e.g. suspected pneumonia, tachypnoea >30 breaths per minute, respiratory failure) 3. Concurrent infection at another site (e.g. UTI, Cellulitis) that is likely to produce a systemic response 4. Past history of respiratory failure or mechanical ventilation 5. Currently on antibiotics or has had antibiotics for this acute exacerbation of COPD 6. Active inflammatory condition (e.g. Flare up of rheumatoid arthritis, gout or polymyalgia rheumatica) 7. Has cystic fibrosis, a current tracheostomy or bronchiectasis 8. Immunocompromised (e.g. AIDS, taking systemic immunosuppressive therapy or receiving anti-cancer radiotherapy or chemotherapy) 9. Currently pregnant 10. Previously been recruited into the PACE study Previous exclusion criteria: 1. Very severe COPD (GOLD stage 4; FEV1 < 30% predicted) 2. Coexisting infection (i.e. urinary tract infection, cellulitis) 3. Suspected pneumonia or requiring immediate hospital admission 4. History of requiring mechanical ventilation for an AECOPD 5. Active chronic inflammatory condition (i.e. rheumatoid arthritis) 6. Currently already taking high dose oral steroids (equivalent to 60mg per day or more of prednisolone) 7. Has taken oral antibiotics in previous four weeks 8. Life limiting malignancy 9. Cystic fibrosis 10. Current tracheotomy 11. Bronchiectasis of any aetiology other than COPD 12. Previously been recruited into the PACE study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 21/02/2017: The PACE study has co-primary outcomes: 1. Antibiotic consumption (any consumption of antibiotics for AECOPD vs. no consumption of antibiotics for AECOPD) within four weeks post-randomisation 2. Recovery in terms of COPD health status, assessed using the clinical COPD questionnaire (CCQ) total scores at two weeks post randomisation Previous primary outcome measures: This study is based on two co-primary outcomes: 1. Antibiotic consumption at any point during the four weeks post-randomisation, measured using telephone interviews at one-week and two-weeks and face-to-face interview at four-weeks 2. Patient-reported health-related quality of life (HRQoL) measured by the Chronic Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) via telephone interview at two-weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 21/02/2017: 1. Prevalence of potentially pathogenic bacteria (incl. S.pneumoniae, H.spp and Enterobacteriacae) and the proportion of bacteria that are resistant, cultured from sputum at 4 weeks post randomisation 2. Prevalence of commensal organisms and the proportion of bacteria that are resistant, cultured from throat swabs at 4 weeks post randomisation 3. COPD health status over time, measured using the CCQ total score measured at weeks 1, 2 and 4 post randomisation 4. CCQ symptoms domain at weeks 1, 2, and 4 post randomisation 5. CCQ function state domain at weeks 1, 2, and 4 post randomisation 6. CCQ mental state domain at weeks 1, 2, and 4 post randomisation 7. Total antibiotic consumption (number of days antibiotics consumed for AECOPD/any reason) during first 4 weeks post randomisation 8. Health utility, measured using the EuroQol-5D (EQ-5D) at weeks 1, 2 and 4 and at month 6 post randomisation 9. All cause antibiotic consumption during the first four weeks post randomisation 10. Antibiotic prescribing at the index consultation 11. Antibiotic prescribing during the first four weeks post randomisation 12. Use of other COPD treatments including oral steroids during the first four weeks post randomisation 13. Adverse effects potentially attributable to antibiotics prescribed for the exacerbation during the first four weeks post randomisation 14. Primary and secondary care consultations, including hospitalisations at week 4 and month 6 15. Costs (total NHS cost) and cost-effectiveness at month 6 16. Incidence of pneumonia, measured by patient and GP report at week 4 and month 6 17. Disease-specific health-related quality of life over time, measured using CRQ-SAS (dyspnoea, fatigue, emotion function, mastery and total scores) at month 6 Previous secondary outcome measures: 1. Prevalence of significant antibiotic resistant organisms (including Streptococcus spp., H. influenzae and parainfluenzae and Enterobacteriaceae) | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed