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Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT02700919•Mereo BioPharma

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (46)

Mereo Research Site

Michigan City, Indiana, United States

Mereo Research Site

Baltimore, Maryland, United States

Mereo Research Site

Milwaukee, Wisconsin, United States

Mereo Research Site

Dupnitsa, Bulgaria

Mereo Research Site

Gabrovo, Bulgaria

Mereo Research Site

Kardzhali, Bulgaria

Mereo Research Site

Kozloduy, Bulgaria

Mereo Research Site

Kyustendil, Bulgaria

Mereo Research Site

Lovech, Bulgaria

Mereo Research Site

Montana, Bulgaria

Key Dates

Start Date

August 1, 2016

Primary Completion Date

November 8, 2017

Completion Date

November 28, 2017

Last Updated

November 30, 2020

Enrollment

282

ACTUAL participants

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

BCT197

DRUG

Placebo

DRUG

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

NCT06831994

Asthma BronchialeBreast Neoplasms+11 more

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RECRUITING

The London COPD Exacerbation Cohort

NCT02755974

Pulmonary Disease, Chronic Obstructive

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ACTIVE_NOT_RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity

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