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NCT Number: NCT01332097

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

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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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Plovdiv, Bulgaria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BCT197

Drug

Prednisone placebo

Drug

capsules

BCT197 placebo

Drug

capsules

Prednisone

Drug

capsules

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

    Time frame: Day 5, Day 10

    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

Secondary outcomes

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

    Time frame: Up to Day 29

    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.

Sponsors and collaborators

Lead sponsor

Mereo BioPharma

Industry

Collaborators

  • Novartis

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 8, 2011
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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