A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Pharmacodynamic Response of Fluticasone Propionate in Fixed-Dose Combination With Formoterol Fumarate in Subjects With COPD

This is a randomized, double-blind, multi-dose, parallel group trial which will assess the pharmacodynamic response of fluticasone propionate and formoterol fumarate in subjects with COPD.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Fluticasone Propionate/Formoterol Fumarate; Drug: Formoterol Fumarate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 468
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States
      • Investigative Site
  • California
    • Fullerton, California, United States
      • Investigative Site
    • San Diego, California, United States
      • Investigative Site
  • Florida
    • Clearwater, Florida, United States
      • Investigative Site
    • Deland, Florida, United States
      • Investigative Site
    • Tamarac, Florida, United States
      • Investigative Site
  • Georgia
    • Lawrenceville, Georgia, United States
      • Investigative Site
  • Idaho
    • Coeur D'Alene, Idaho, United States
      • Investigative Site
  • Kentucky
    • Madisonville, Kentucky, United States
      • Investigative Site
  • Louisiana
    • Sunset, Louisiana, United States
      • Investigative Site
  • Missouri
    • Saint Louis, Missouri, United States
      • Investigative Site
  • North Carolina
    • Charlotte, North Carolina, United States
      • Investigative Site
    • Raleigh, North Carolina, United States
      • Investigative Site
  • Ohio
    • Sylvania, Ohio, United States
      • Investigative Site
  • Oregon
    • Medford, Oregon, United States
      • Investigative Site
  • South Carolina
    • Easley, South Carolina, United States
      • Investigative Site
    • Gaffney, South Carolina, United States
      • Investigative Site
    • Greenville, South Carolina, United States
      • Investigative Site
    • Greer, South Carolina, United States
      • Investigative Site
    • Spartanburg, South Carolina, United States
      • Investigative Site
    • Union, South Carolina, United States
      • Invesigative Site
  • Texas
    • San Antonio, Texas, United States
      • Investigative Site
  • Washington
    • Spokane, Washington, United States
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Able to understand the requirements of the study and provide written informed consent
• A clinical diagnosis of COPD
• A current or prior history of at least 10-pack years of cigarette smoking
• Women of child-bearing potential (WOCBP) must have a negative pregnancy test at the screening visit and agree to avoid becoming pregnant for the duration of study

Exclusion Criteria:

• A clinical diagnosis of Asthma
• Other significant disease than COPD
• Subjects who radiation or chemotherapy within the previous 12 months
• Subjects who had any lung resection
• QTcB greater than 0.460 seconds
• History of illegal drug abuse or alcohol abuse within the past 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Fluticasone Propionate/Formoterol Fumarate; Inhalation Suspension
Experimental: 2	Drug: Fluticasone Propionate/Formoterol Fumarate; Inhalation Suspension
Experimental: 3	Drug: Fluticasone Propionate/Formoterol Fumarate; Inhalation Suspension
Experimental: 4	Drug: Fluticasone Propionate/Formoterol Fumarate; Inhalation Suspension
Experimental: 5	Drug: Fluticasone Propionate/Formoterol Fumarate; Inhalation Suspension
Placebo Comparator: 7	Drug: Placebo; Inhalation Solution
Active Comparator: 6	Drug: Formoterol Fumarate; Inhalation Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in forced expiratory volume at one second (FEV1) measured in milliliters by spirometry to assess pharmacodynamic response of fluticasone propionate in combination with formoterol fumarate in subject with COPD	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of adverse events (AEs)	12 Weeks

Collaborators and Investigators

• Sponsor: Dey

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimate): July 23, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2013
• Last Update Submitted That Met QC Criteria: May 17, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Pulmonary, Obstructive, lungs, COPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Formoterol Fumarate
• Other Study ID Numbers: 191-090