NCT01584505

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Cardiac Safety Study

Detailed 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.

Conditions

• Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	CHF1535 + CHF5992 dose 1 BID	CHF1535 + CHF5992 dose 1 BID for 14 days
DRUG	CHF1535 + CHF5992 dose2 BID	CHF1535 + CHF5992 dose 2 BID for 14 days
DRUG	CHF1535 daily dose	CHF1535 daily dose for 14 days

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-09-01
• Completion: 2013-01-01
• First posted: 2012-04-25
• Last updated: 2021-10-29

Locations

6 sites across 6 countries: Bulgaria, Germany, Hungary, Poland, Russia, United Kingdom