1. STudying Acute exaceRbations and Response: The COPD STARR 2 study

2. STARR 2 Team Research Nurses – Helen Jeffers & Joanne Davies
Contact interested patients (once initial contact has been made by GP surgery)
Consent & randomise participants
Conduct trial visits
Dispense prednisolone/placebo
CRF completion/data entry
CI – Dr Mona Bafadhel

3. Trial Summary
Current treatment of corticosteroids and antibiotics during an exacerbation = “one size fits all”.
Follow on from STARR study which identified eosinophils as a biomarker during exacerbations.
STARR 2 is looking at whether an eosinophil- directed therapy to personalise treatment reduces inappropriate and excessive drug therapy.
10 GP surgeries in Thames Valley
GPs will be PI for each site

4. PI Responsibilities
The PI has overall responsibility for activity at a site and it is their role to ensure that site staff are suitably trained for responsibilities he/she has delegated at the start and throughout the trial.
The safety of participants should be overseen by the responsible PI at site. Before a trial is opened at a site, the PI should complete this training to ensure they have understood the trial and their responsibility as PI for STARR 2.
In the event that a PI is off on annual leave, the PI should delegate responsibility to another GP to cover their duties in the interim. Especially to ensure there is cover in the event of an SAE.
If a PI leaves the surgery, the trial manager needs to be notified immediately as they will give guidance on how to proceed at site.

5. Inclusion Criteria
Participant is willing and able to give informed consent for participation in the trial.
Male or Female, aged 40 years or above.
Diagnosed with COPD (FEV1/FVC ratio <0.7).
A history of at least 1 exacerbation in the previous 12 months, requiring systematic corticosteroids and/or antibiotics.
Current or ex-smoker with at least 10 pack year smoking history.
In the opinion of the research staff, is able and willing to comply with all trial requirements.

6. Exclusion Criteria History of atopic childhood asthma.
Current history of primary lung malignancy or active pulmonary TB.
Clinically relevant disease or disorder (past or present)
Any clinically relevant lung disease, other than COPD considered by the investigator to be the primary diagnosis.
An alternative cause for the increase in symptoms of COPD
pneumonia
pulmonary embolism
pneumothorax
primary ischaemic event – ST or Non ST elevation myocardial infarct and left ventricular failure

7. Exclusion Criteria (cont)
A known allergy to the IMP (prednisolone), NIMP (doxycycline) or to any of the constituents of the placebo
Patients on maintenance corticosteroids (prednisolone, hydrocortisone, fludrocortisone)
Known adrenal insufficiency
Currently enrolled in another CTIMP trial and receiving intervention as part of the trial.
Pregnant and breast-feeding women.

8. Stable Visit
This is a scheduled visit and occurs when the participant is 6 weeks free from an exacerbation. This visit can occur immediately following informed consent or following randomisation at a subsequent later date.
All data obtained can be added directly to patient’s record.
Spirometry; FeNO; MRC, HADS, VAS & CAT scores

9. Intervention Overview

10. Randomisation Procedure
Randomisations for STARR 2 will be via RRAMP. This is a web based system that can be accessed from anywhere with an internet connection.
The STARR 2 research nurses will perform the randomisations.
The PIs at each site will receive notification s through when a new participant has been randomised at their site.
There is no emergency randomisation method.

11. Emergency Unblinding
All emergency unblinding will be at the discretion of the local PI when clinically indicated for the safety of the patient.
Emergency unblinding can be performed via RRAMP by the STARR 2 Research Nurses, the PI or the Trial Manager (if required).
Non-emergency unblinding can be requested via the RRAMP system and will require approval by the CI.

12. Where Next?
What the research is looking at and how this may influence future practice?
Point of care testing
Prescribing based on eosinophil count and CRP
Personalised exacerbation treatment

13. Any questions? Contact Details:
CI – Prof Mona Bafadhel:
Research Nurse – Helen Jeffers:
Research Nurse – Joanne Davies:
Trial Manager – Hania Piotrowska: –