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

NCT02700919 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2020-11-30

Study results available
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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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

BCT197

Capsules will be taken orally with fluids over a 5 day period after randomization

DRUG

Placebo

Capsules will be taken orally with fluids over a 5 day period after randomization

Sponsors & Collaborators

  • Mereo BioPharma

    lead INDUSTRY

Principal Investigators

  • Jacqueline Parkin, PhD FRCP · Mereo BioPharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2017-11-08
Completion
2017-11-28

Countries

  • United States
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Italy
  • Latvia
  • Poland
  • Romania
  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02700919 on ClinicalTrials.gov