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Safety & Efficacy of BCT197A2201 in COPD Patients Presenting With an Exacerbation

NCT ID: NCT01332097

Last Updated: 2023-03-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-05-31

Brief Summary

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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.

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Detailed Description

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This was an exploratory, double-blind, randomized, placebo-controlled, multicenter, adaptive parallel-group design study in four parts in patients with acute COPD exacerbation. In Part I, patients were randomized to receive either a single dose of 75mg BCT197, placebo or 40 mg oral prednisone in the ratio of 1:1:1. In Part II patients were randomized to receive either a single dose of 20 mg BCT197 or placebo in the ratio of 5:1. Patients in Parts I and II received their single dose on Day 1 of the study. In Parts III and IV patients were randomized to receive either BCT197 or placebo in a ratio of 5:1 at a dose of 20mg (Part III) or 75 mg (Part IV) with patients receiving a single dose on both Day 1 and Day 6 of the study.

Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment A

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

Group Type EXPERIMENTAL

BCT197

Intervention Type DRUG

Prednisone placebo

Intervention Type DRUG

capsules

Treatment B/G/E/I

Matching placebo comparator arm

Group Type PLACEBO_COMPARATOR

Prednisone placebo

Intervention Type DRUG

capsules

BCT197 placebo

Intervention Type DRUG

capsules

Treatment C

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

Group Type ACTIVE_COMPARATOR

BCT197 placebo

Intervention Type DRUG

capsules

Prednisone

Intervention Type DRUG

capsules

Treatment D

Single oral dose of 20mg dose of BCT197 capsules

Group Type EXPERIMENTAL

BCT197

Intervention Type DRUG

Treatment F

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

Group Type EXPERIMENTAL

BCT197

Intervention Type DRUG

Treatment H

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

Group Type EXPERIMENTAL

BCT197

Intervention Type DRUG

Interventions

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BCT197

Intervention Type DRUG

Prednisone placebo

capsules

Intervention Type DRUG

BCT197 placebo

capsules

Intervention Type DRUG

Prednisone

capsules

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Use of steroids in the last 30 days or calcium channel blockers in the last 48 hours.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

Mereo BioPharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacqueline Parkin, PhD FRCP

Role: STUDY_DIRECTOR

Mereo BioPharma

Locations

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Novartis Investigative Site

Plovdiv, , Bulgaria

Site Status

Novartis Investigative Site

Rousse, , Bulgaria

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Countries

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Bulgaria Romania Russia

References

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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.

Reference Type DERIVED
PMID: 31682162 (View on PubMed)

Other Identifiers

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2010-021723-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CBCT197A2201

Identifier Type: -

Identifier Source: org_study_id

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