A Safety, Tolerability and Efficacy Study in COPD Patients With QBM076.

COPD Clinical Trial

Official title: A Two Part, Double Blind, Placebo Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Multiple Doses of QBM076 in Patients With COPD

Status Terminated

Clinical Trial Summary

This is a 2 Part study. Part 1 is a safety and tolerability study in GOLD I-III COPD patients. Part 2 is an efficacy study in GOLD I-III COPD patients.

Clinical Trial Description

Part 1 is a double-blind, randomized, placebo-controlled, non-confirmatory study in chronic bronchitis COPD patients. 32 patients will be enrolled in up to 4 cohorts. Patients will be randomized in a 3:1 ratio. Part 1 will consist of up to 27-days of screening period, one baseline period of 1 day, 13 days of bid dosing with study treatment, morning only treatment on Day 14, follow up visits on Days 15 - 17, followed by a Study Completion evaluation.

Part 2 is a double-blind, randomized, placebo-controlled, non-confirmatory study in Gold spirometry grades I-III COPD patients. 90 patients will be randomized in a 2:1 ratio. The study will consist of up to 20 days of screening period, a 9 day run in period, one baseline period of 1 day, 55 days of bid dosing, morning only dosing on Day 56, followed by Study Completion evaluation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• COPD

• NCT number: NCT01972776
• Study type: Interventional
• Source: Novartis
• Status: Terminated
• Phase: Phase 2
• Start date: November 2013
• Completion date: December 2015