A Phase IIa, two-part, randomised, multi-centre, multinational, double-blind, placebo-controlled, parallel group study to compare the efficacy and safety of BCT197 when added on to standard of care for the treatment of acute respiratory exacerbations of chronic obstructive pulmonary disease (COPD) requiring hospitalisation in adults.

Mereo BioPharma 1 Ltd0 sites270 target enrollmentStarted: April 20, 2016Last updated: June 18, 2018

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor
Enrollment: 270

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Male and female adults aged = 40 years
•2. Written informed consent obtained prior to any study-related
•3. Presence of an active exacerbation of the ongoing COPD requiring
•hospitalisation for treatment:
•A sustained worsening of the patient's condition (dyspnoea, cough
•and/or sputum production/purulence), from the stable state and beyond
•normal day-to-day variations, that is acute in onset and necessitates a
•change in regular medication in a patient with underlying COPD that
•includes prescriptions of systemic corticosteroids and/or antibiotics and
•need for hospitalisation
•4. Subjects with a diagnosis of COPD with spirometry performed outside
•an exacerbation within the last 12 months prior to the Screening Visit.
•5. Current smokers or ex-smokers with a smoking history of at least 10
•pack-years (pack-years = [number of cigarettes per day x number of
•6. A FEV1 < 65% of the predicted normal value.
•7. A documented history of at least one moderate or severe COPD
•exacerbation in the 12 months preceding the Screening Visit that
•required antibiotics and/or systemic corticosteroid (addition or
•increment on subject current use) as defined below:
•o A sustained worsening of the patient's condition (dyspnoea, cough
•and/or sputum production/purulence), from the stable state and beyond
•normal day-to-day variations, that is acute in onset and necessitates a
•change in regular medication in a patient with underlying COPD that
•includes prescriptions of systemic corticosteroids and/or antibiotics or
•need for hospitalisation
•o Also, documented visits to an emergency department due to COPD
•exacerbation are considered acceptable to fulfil this criterion.
•8. Current regular treatment for COPD (categories C and D according to
•GOLD guidelines, updated 2015) for at least 2 months prior to the
•Screening Visit with either:
•Inhaled corticosteroids/long-acting ß2-agonist combination, longacting
•muscarinic antagonist without regular use of any short-acting
•bronchodilator (any short-acting bronchodilator allowed if used as
•needed [PRN]) or
•Inhaled corticosteroids/long-acting ß2-agonist combination, without
•regular use of any short-acting bronchodilator (any short-acting
•bronchodilator allowed if used PRN) or
•Inhaled corticosteroids/long-acting muscarinic antagonist
•combination, without regular use of any short-acting bronchodilator (any
•short-acting bronchodilator allowed if PRN) or
•Inhaled long-acting ß2-agonist and inhaled long-acting muscarinic
•antagonist (with any PRN short acting bronchodilator) or
•Subjects under monotherapy with long-acting muscarinic antagonist
•(with any PRN short acting bronchodilator).
•9. Ideally subjects should be screened, randomised and dosed on the
•same day. Where information is not available, the Screening period can
•be extended to a maximum of 24 hours before Randomisation and
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
+3 more not shown

Exclusion Criteria

•1. Current diagnosis of asthma
•2. Subjects who have already completed treatment for current
•exacerbation of COPD
•3. Subjects who have been treated with or require the following
•medications:
•Systemic steroids for longer than 3days for COPD exacerbation in the
•4weeks prior to the current exacerbation
•Antibiotics for COPD exacerbation for longer than 7days in the 4weeks
•prior to the current exacerbation
•Phosphodiesterase type 3/4 inhibitors
•Any p38 mitogen-activated protein kinase inhibitor treatment
•Antibiotics for lower respiratory tract infection in the 4weeks prior to
•the current exacerbation (except for treatment of the current
•exacerbation, but not longer than 2days)
•4. Subjects currently requiring intensive care unit and/or mechanical
•ventilation
•5. Subjects treated with non-cardioselective ß-blockers in the 10days
•preceding Screening Visit. Those subjects may enter the study after nonselective
•ß-blockers withdrawal and/or cardioselective ß-blockers intake
•for at least 10days before Randomisation
•6. Subjects treated with long-acting anti-histamines unless taken at
•stable regimen at least 2months prior to Screening and to be maintained
•constant during the study, or if taken as PRN
•7. Known respiratory disorders other than COPD which may impact
•efficacy of study drug according to the investigator's judgement. This
•can include but is not limited to a-1 antitrypsin deficiency, active
•tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis,
•pulmonary hypertension and interstitial
•lung disease
•8. Subjects who have had pulmonary lobectomy or lung volume
•reduction surgery or lung transplantation
•9. Subjects who have had a live vaccination in the last 30 days prior to study start
•10. Subjects who have a clinically significant cardiovascular condition
•(including, but not limited to, unstable ischemic heart disease, NYHA
•Class III/IV, left ventricular failure, acute myocardial infarction); or
•current exacerbation is due to a cardiovascular condition
•11. An abnormal and clinically significant 12-lead ECG which may impact
•safety of the subject according to the investigator's judgement at
•Screening or Baseline
•12. Subjects whose 12-lead ECG shows QTcF > 450 msec at Screening
•and at Randomisation visits; ECG does not need to be repeated if
•Screening and Randomisation visit are on the same day
•13. Current diagnosis of pneumonia, pulmonary embolus or
•pneumothorax.
•14. History of hypersensitivity to anti-cholinergics, ß2-agonist,
•corticosteroids or any excipients contained in the formulations used in
•the study which may raise contra-indications or impact the efficacy of
•the study drug according to the investigator's clinical judgement
•15. Clinically significant laboratory abnormalities indicating a significant
•or unstable concomitant disease which may impact the efficacy or the
+11 more not shown

Investigators

Sponsor

Mereo BioPharma 1 Ltd

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