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Stratified TreAtment to Reduce Risk in COPD (STARR2)

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ClinicalTrials.gov Identifier: NCT04458636
Recruitment Status : Completed
First Posted : July 7, 2020
Last Update Posted : July 21, 2020
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Mona Bafadhel, University of Oxford

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.

Condition or disease Intervention/treatment Phase
COPD Exacerbation Drug: Prednisolone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Delivering Personalised Care in the Management of Exacerbations of Chronic Obstructive Pulmonary Disease: A Multi-centre Randomised Clinical Trial
Actual Study Start Date : November 2, 2017
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : April 30, 2020


Arm Intervention/treatment
Active Comparator: Standard care
Blinded prednisolone 30mg orally once per day for 14 days
Drug: Prednisolone
Oral

Placebo Comparator: Biomarker care
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
Oral




Primary Outcome Measures :
  1. Proportion of treatment non-responders defined as those needing re-treatment, hospitalisation or death at 30 and 90 days [ Time Frame: 30 days ]
    Frequency of treatment non-responders, defined as those needing re-treatment, hospitalisation or death


Secondary Outcome Measures :
  1. COPD assessment test (CAT) [ Time Frame: Day 14, 30 and 90 ]
    CAT questionnaire. A higher score (max score of 40) reflects worse COPD symptoms

  2. Quality of life - change from baseline [ Time Frame: Day 14, 30 and 90 ]
    European Quality of Life-5 dimension-3 level (EQ 5D 3L) questionnaire. A higher number on each of the 5 dimension reflects worse quality of life

  3. Visual analogue scale (VAS) for cough, wheeze, sputum volume, sputum purulence and breathlessness [ Time Frame: Day 14, 30 and 90 ]
    Visual Analogue Scale (VAS) symptom score (scale of 0 to 100 - 100 being the worst). Separate scale for 5 items: cough, wheeze, sputum volume, sputum purulence and breathlessness. Results will be represented as a sum of all 5 scores at each time point.

  4. Lung function [ Time Frame: Day 14, 30 and 90 ]
    Change from baseline in FEV1

  5. Exacerbations [ Time Frame: 12 months ]
    Frequency of moderate and severe exacerbations



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458636


Locations
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United Kingdom
Nuffield Department of Medicine
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Mona Bafadhel, MBChB, PhD University of Oxford
Additional Information:
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Responsible Party: Mona Bafadhel, Associate Professor, University of Oxford
ClinicalTrials.gov Identifier: NCT04458636    
Other Study ID Numbers: 17/LO/1135
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: upon request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mona Bafadhel, University of Oxford:
eosinophils
oral corticosteroids
primary care
Additional relevant MeSH terms:
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Prednisolone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents