Topic: Primary Care
Conditions
Interventions
Scheduled baseline visit 1
Demographic history: Participant demographics including age, smoking history and past COPD medical history will be collected.
Medication hist
COPD Assessment Tool
the Hospital Anxiety and Depression Scale and the EuroQol 5D. Participants will be asked to complete a daily diary for assessment of symptoms and recovery following treatment. Instructions to use thes
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Male or female, aged 40 years or above. 3. Known diagnosis of COPD (either diagnosis made in primary or secondary care) as per national and international guidelines (NICE, 2010 & GOLD 2013), irrespective of severity 4. Current or ex-smoker 5. Smoking pack year history >10 6. Spirometry confirming fixed airflow obstruction (FEV1/FVC ratio <0.7) Target Gender: Male & Female; Lower Age Limit 40 years
Exclusion criteria
Exclusion criteria: 1. History of atopic childhood asthma 2. Current history of primary lung malignancy or current active pulmonary TB 3. Upon questioning the participant is HIV, hepatitis B or C positive 4. Clinically relevant disease or disorder (past or present) which in the opinion of the investigator may either put the subject at risk because of participating in the study or may influence the results of the study or the subject’s ability to participate in the study 5. Any clinically relevant lung disease other than COPD, considered by the investigator to be the primary diagnosis. For example mild to moderate bronchiectasis is acceptable in addition to COPD unless the bronchiectasis is considered to be the primary diagnosis 6. An alternative cause for the increase in symptoms of COPD that are unrelated to an exacerbation such as 6.1. Suspicion or clinical evidence of pneumonia 6.2. High probability and suspicion of pulmonary embolism 6.3. Suspicion or clinical evidence of a pneumothorax 6.4. Primary ischaemic event – ST or non ST elevation myocardial infarct and left ventricular failure (i.e., not an exacerbation of COPD)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Measure the incidence of eosinophilic and non-eosinophilic COPD phenotypes in primary care. Using near-patient testing the blood eosinophil count and C reactive protein result will be used to quantify this at each stable assessment 2. Quantify the proportion of treatment responses and failures to standard/usual treatment for a COPD exacerbation in primary care. Treatment failure is defined as requiring further courses of treatment, medical review, hospitalisation or death within 30 days; subjects will be interviewed at 3 days to review the evidence for any treatment failure event. A treatment responder will be subjects that do not have a treatment failure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Measure patient-reported outcomes (symptoms, health status and healthcare utilisation) following treatment of an exacerbation of COPD. Quantified using the CAT, EuroQoL, MRC and VAS at day 30 and day 90 of an exacerbation 2. Derive pilot data quantifying treatment response following standard treatment of an exacerbation of COPD in primary for a future randomised clinical trial. Quantified at the end of the study period after the last subject has completed the follow-up data | — |
Countries
United Kingdom
Outcome results
None listed