STudying Acute exaceRbations and Responses: COPD STARR Study. v1.0

• Register: ISRCTN
• Last refreshed on: 17 May 2021
• Main ID: ISRCTN90445176
• Date of registration: 20/08/2015
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: STudying Acute exaceRbations and Responses: COPD STARR Study. v1.0
• Scientific title: Studying the different characteristics of chronic obstructive pulmonary disease in primary care using near-patient testing and relating this to treatment responses during an acute exacerbation
• Date of first enrolment: 01/05/2015
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN90445176
• Study type: Observational
• Study design: Non-randomised; Observational; Design type: Cohort study (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Mona Bafadhel

Key inclusion & exclusion 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:
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)


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Primary Care; Subtopic: Primary care; Disease: All Diseases
Not Applicable

Intervention(s)

Scheduled baseline visit 1
Demographic history: Participant demographics including age, smoking history and past COPD medical history will be collected.
Medication history: Full medication history will be collected, including the use of as required and over the counter medication. Any drug allergy will be documented and dates of flu vaccination, S. pneumoniae and H. influenzae B vaccinations will be recorded from medical records.
Past medical history: Full medical history will be collected from the participant and from the medical notes. The Charlson Comorbidity Index will be calculated.
COPD diagnosis history: The age of onset and age of diagnosis of COPD symptoms will be recorded from the participant and from the medical records.
Past exacerbation history: The frequency of exacerbations, including those requiring hospitalisation in the previous 12 months, will be captured from participant recollection and from the medical records. Medication prescribed at each exacerbation event (if available) from medical records will be captured.
Questionnaires: Patient reported outcome measures (PROs) will be sought to specifically test symptoms, health status, quality of life and any associated depression and anxiety. This will use the Medical Research Council dyspnoea scale; Visual analogue score; 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 these questionnaires will be given to all participants. Each of these questionnaires are validated to be self-completed for ease of use.

Near p

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

18557

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

15SC0025; First MREC approval date 13/02/2015

Results

• Results available: Yes
• Date Completed: 31/12/2017