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Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

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ClinicalTrials.gov Identifier: NCT02700919
Recruitment Status : Completed
First Posted : March 7, 2016
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Mereo BioPharma

Brief Summary:
The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: BCT197 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, 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 Requiring Hospitalisation in Adults
Actual Study Start Date : August 1, 2016
Actual Primary Completion Date : November 8, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Regimen 1
Drug: BCT197 Dose 1, Day 1 to Day 5
Drug: BCT197
Capsules will be taken orally with fluids over a 5 day period after randomization

Experimental: Regimen 2
Drug: BCT197 Dose 2, Day 1 to Day 5
Drug: BCT197
Capsules will be taken orally with fluids over a 5 day period after randomization

Placebo Comparator: Regimen 3
Placebo Day 1 to Day 5
Drug: Placebo
Capsules will be taken orally with fluids over a 5 day period after randomization




Primary Outcome Measures :
  1. Comparison of change in forced expiratory volume in 1 second (FEV1) from Baseline (pre-dose) to Day 7 [ Time Frame: Baseline, Day 7 ]


Information from the National Library of Medicine

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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:

  • Male and female adults
  • Presence of an active exacerbation of the ongoing COPD requiring hospitalization for treatment
  • Subjects with a documented diagnosis of COPD C or D
  • Current smokers or ex-smokers
  • 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.
  • Current regular treatment for COPD (for at least 2 months prior to the Screening Visit.

Exclusion Criteria:

  • Age less than 40 years old
  • Current diagnosis of asthma
  • Subjects who have already completed treatment for the current exacerbation of COPD
  • Subjects currently requiring intensive care unit (ICU) and/or mechanical ventilation
  • Received a course of PDE4, p38 or PDE3/4 inhibitors within their respective defined washout periods.

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): NCT02700919


  Show 46 Study Locations
Sponsors and Collaborators
Mereo BioPharma
Investigators
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Study Director: Jacqueline Parkin, PhD FRCP Mereo BioPharma

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Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT02700919     History of Changes
Other Study ID Numbers: MBCT206
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases