Phase II Study to Evaluate the Cardiac Safety of 2 Doses of CHF5993 Both Combined With CHF1535 BID Versus CHF1535 BID in Patients With Moderate to Severe COPD — CARSAF  

Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title: Randomized, Double-Blind, Active Controlled, 3-Arm Parallel Group, Multi-National, Multi-Centre Study To Evaluate The Cardiac Safety Of Two Doses Of CHF5993 BID Delivered Via HFA PMDI Both Combined With CHF1535 BID Delivered Via HFA PMDI Versus CHF1535 BID Delivered Via HFA PMDI In Patients With Moderate To Severe COPD

Status Completed

Clinical Trial Summary

Cardiac Safety Study

Clinical Trial Description

The purpose of this study is to demonstrate equivalence between CHF1535 plus CHF5992 (two different dosages) over CHF1535 alone in change from baseline in average 24-hour heart rate, as primary end point, and other ECG parameters. ;

Related Conditions & MeSH terms

• Lung Diseases, Obstructive
• Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT01584505
• Study type: Interventional
• Source: Chiesi Farmaceutici S.p.A.
• Status: Completed
• Phase: Phase 2
• Start date: April 2012
• Completion date: January 2013