Stratified TreAtment to Reduce Risk in COPD

NCT04458636 | Completed Phase 4 DMC

• 1 other identifier: 17/LO/1135
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD Exacerbation

Keywords

eosinophils; oral corticosteroids; primary care

Outcome Measures

Primary Outcomes (1)

• Proportion of treatment non-responders defined as those needing re-treatment, hospitalisation or death at 30 and 90 days

  Frequency of treatment non-responders, defined as those needing re-treatment, hospitalisation or death

  30 days

Secondary Outcomes (5)

• COPD assessment test (CAT)

  Day 14, 30 and 90

• Quality of life - change from baseline

  Day 14, 30 and 90

• Visual analogue scale (VAS) for cough, wheeze, sputum volume, sputum purulence and breathlessness

  Day 14, 30 and 90

• Lung function

  Day 14, 30 and 90

• Exacerbations

  12 months

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Blinded prednisolone 30mg orally once per day for 14 days

Drug: Prednisolone

Biomarker care

PLACEBO COMPARATOR

Blinded prednisolone 30mg orally once per day for 14 days if peripheral eosinophil count is equal or greater than 2%. Placebo equivalent if peripheral blood eosinophil count is \<2%.

Drug: Prednisolone

Interventions

Prednisolone DRUG

Oral

Biomarker care; Standard care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Nuffield Department of Medicine

Oxford, United Kingdom

Location

Related Links

• Website address for CI

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mona Bafadhel, MBChB, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 20, 2017
• First Posted: July 7, 2020
• Study Start: November 2, 2017
• Primary Completion: February 28, 2020
• Study Completion: April 30, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

GB (1)