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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

An Exploratory, Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Efficacy, Safety and Tolerability of a Single and a Repeated Dose of Oral BCT197 in Patients With an Acute COPD Exacerbation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332097
• Other study ID #: CBCT197A2201
• Secondary ID: 2010-021723-27
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: May 2013

Study information

• Verified date: February 2023
• Source: Mereo BioPharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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. Other protocol-defined inclusion/exclusion criteria may apply

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BCT197

• Prednisone placebo
capsules
• BCT197 placebo
capsules
• Prednisone
capsules

Locations

Country	Name	City	State
Bulgaria	Novartis Investigative Site	Plovdiv
Bulgaria	Novartis Investigative Site	Russe
Romania	Novartis Investigative Site	Bucuresti
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St. Petersburg

Sponsors (2)

Lead Sponsor	Collaborator
Mereo BioPharma	Novartis

Countries where clinical trial is conducted

Bulgaria,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rolling Average Improvement From Day 1 to Day 29 Using the EXACT-PRO 14 Point Patient Reported Outcome Measure: EXACT-PRO	EXAcerbations of Chronic pulmonary disease tool patient reported outcome (EXACT-PRO) Rolling Average Improvement from Day 1 to Day 29. EXACT-PRO is a 14 point patient reported daily diary used to quantify and measure exacerbations of chronic obstructive pulmonary disease (COPD). Minimum score is 0 and Maximum score is 14 (higher scores indicate worsening indicative of an exacerbation). Reported value is LS mean improvement from at Day 29 compared to D1 of the study.	Up to Day 29