NCT01332097

Brief Summary

This study will assess preliminary parameters of safety and efficacy of a single dose of BCT197 in patients with a Chronic Obstructive Pulmonary Disease (COPD) exacerbation.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Mar 2011

Typical duration for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

March 21, 2023

Completed
Last Updated

March 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.2 years

First QC Date

April 7, 2011

Results QC Date

October 25, 2017

Last Update Submit

February 22, 2023

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseExacerbationPulmonary Inflammation

Outcome Measures

Primary Outcomes (1)

  • Change in FEV1 From Baseline to Day 5 or Baseline to Day 10 Measure: FEV1 Change in Forced Expiry Volume in 1 Second

    Change in FEV1 from baseline to Day 5 or baseline to Day 10 measured in mL Measure: FEV1 Change in Forced Expiry Volume in 1 second

    Day 5, Day 10

Secondary Outcomes (1)

  • Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO

    Up to Day 29

Study Arms (6)

Treatment A

EXPERIMENTAL

Single 75mg oral dose of BCT197 capsules + single oral dose of prednisone placebo capsules

Drug: BCT197Drug: Prednisone placebo

Treatment B/G/E/I

PLACEBO COMPARATOR

Matching placebo comparator arm

Drug: Prednisone placeboDrug: BCT197 placebo

Treatment C

ACTIVE COMPARATOR

Single oral dose of BCT 197 placebo capsules + single oral dose of 40mg prednisone capsules

Drug: BCT197 placeboDrug: Prednisone

Treatment D

EXPERIMENTAL

Single oral dose of 20mg dose of BCT197 capsules

Drug: BCT197

Treatment F

EXPERIMENTAL

Single oral dose of 20 mg dose of BCT197 capsules on Day 1 and Day 6

Drug: BCT197

Treatment H

EXPERIMENTAL

Single oral dose of 75mg dose of BCT197 capsules on Day 1 and Day 6

Drug: BCT197

Interventions

BCT197DRUG
Treatment ATreatment DTreatment FTreatment H
Prednisone placeboDRUG

capsules

Treatment ATreatment B/G/E/I
BCT197 placeboDRUG

capsules

Treatment B/G/E/ITreatment C
PrednisoneDRUG

capsules

Treatment C

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with COPD (Stage II to IV) with a COPD exacerbation.
  • Smoking history of 10 pack years.
  • Females must not be of child-bearing potential.

You may not qualify if:

  • Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site

Plovdiv, 4000, Bulgaria

Location

Novartis Investigative Site

Rousse, 7002, Bulgaria

Location

Novartis Investigative Site

Bucharest, 50159, Romania

Location

Novartis Investigative Site

Moscow, 107014, Russia

Location

Novartis Investigative Site

Moscow, 117292, Russia

Location

Novartis Investigative Site

Saint Petersburg, 191015, Russia

Location

Related Publications (1)

  • Strambu IR, Kobalava ZD, Magnusson BP, MacKinnon A, Parkin JM. Phase II Study of Single/Repeated Doses of Acumapimod (BCT197) to Treat Acute Exacerbations of COPD. COPD. 2019 Dec;16(5-6):344-353. doi: 10.1080/15412555.2019.1682535. Epub 2019 Nov 4.

    PMID: 31682162DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructivePneumonia

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfections

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Jackie Parkin
Organization
Mereo BioPharma
enquiries@mereobiopharma.com
+44 333 0237300

Study Officials

  • Jacqueline Parkin, PhD FRCP

    Mereo BioPharma

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 8, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 21, 2023

Results First Posted

March 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(3)BU(2)RO(1)