A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 compared to PT005 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

ID Number 16-1949

Principal Investigator(s)
E. Neil Schachter

Department(s) or Division(s)
Pulmonary, Critical Care and Sleep Medicine

Description

The purpose of this study is to see if the investigational (experimental not approved by the Food and Drug Administration FDA) study drug Budesonide and Formoterol Fumarate Inhalation Aerosol Metered Dose Inhaler (BFF MDI), and Formoterol Fumarate Inhalation Aerosol Metered Dose Inhaler (FF MDI/) have an effect on the rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations (worsening of COPD symptoms) and lung function.

Subjects may qualify to take part in this research study because they have Chronic Obstructive Pulmonary Disease (COPD) which may be called emphysema or chronic bronchitis and the study doctor thinks they are suitable for the study.

The study is "double-blinded" meaning neither participants nor the study staff will know which study drug they will receive. During the study, participants will be randomly (by chance) assigned to receive one of three study treatments. The chance of being assigned to a particular study treatment is 33%. Neither the subject nor the study doctor can choose a group. They will be told only in case of emergency.

Participation in this research study is expected to last at least 55 weeks and may last 64 weeks.The total number of people expected to take part in this research study at this site is 10.



Contact Information
Diana Valerio
(212) 241-9538
diana.valerio@mssm.edu

Recruiting Patients: Yes