Stratified TreAtment to Reduce Risk in COPD

• Status: Completed
• Trial end date: 2020-04-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of blood-eosinophil directed corticosteroid therapy using near-patient testing, compared to current standard practice during an exacerbation of COPD in a multi-centre randomised placebo controlled trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborator: National Institute for Health Research, United Kingdom
• Treatments: Prednisolone

Criteria

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 (primary or secondary care diagnosis) with spirometric confirmation of airflow obstruction (FEV1/FVC ratio <0.7).

• A history of at least 1 exacerbation in the previous 12 months, requiring systemic corticosteroids and/or antibiotics.

• Current or ex-smoker with at least a 10 pack year smoking history

• In the opinion of the research staff, is able and willing to comply with all trial requirements.

Exclusion Criteria:

• History of atopic childhood asthma

• Current history of primary lung malignancy or current active pulmonary TB

• 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.

• 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.

• An alternative cause for the increase in symptoms of COPD that are unrelated to an exacerbation such as i) suspicion or clinical evidence of pneumonia; ii) high probability and suspicion of pulmonary embolism; iii) suspicion or clinical evidence of a pneumothorax; iv) primary ischaemic event - ST or Non ST elevation myocardial infarct and left ventricular failure [i.e. not an exacerbation of COPD]

• 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 an intervention as part of the trial.

• Pregnant and breast-feeding women