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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluticasone Propionate/Formoterol Fumarate
Fluticasone Propionate/Formoterol Fumarate
Fluticasone Propionate/Formoterol Fumarate
Fluticasone Propionate/Formoterol Fumarate
Fluticasone Propionate/Formoterol Fumarate
Formoterol Fumarate
Placebo
Sponsored by
Dey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Pulmonary, Obstructive, lungs, COPD

Eligibility Criteria

40 Days - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Investigative Site
  • Invesigative Site
  • Investigative Site
  • Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

1

2

3

4

5

6

7

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of adverse events (AEs)

Full Information

First Posted
July 21, 2010
Last Updated
May 17, 2013
Sponsor
Dey
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1. Study Identification

Unique Protocol Identification Number
NCT01168310
Brief Title
A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dey

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Pulmonary, Obstructive, lungs, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
468 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Active Comparator
Arm Title
7
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate/Formoterol Fumarate
Intervention Description
Inhalation Suspension
Intervention Type
Drug
Intervention Name(s)
Formoterol Fumarate
Intervention Description
Inhalation Solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Inhalation Solution
Primary Outcome Measure Information:
Title
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
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigative Site
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Investigative Site
City
Fullerton
State/Province
California
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigative Site
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Investigative Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
Investigative Site
City
Tamarac
State/Province
Florida
Country
United States
Facility Name
Investigative Site
City
Lawrenceville
State/Province
Georgia
Country
United States
Facility Name
Investigative Site
City
Coeur D'Alene
State/Province
Idaho
Country
United States
Facility Name
Investigative Site
City
Madisonville
State/Province
Kentucky
Country
United States
Facility Name
Investigative Site
City
Sunset
State/Province
Louisiana
Country
United States
Facility Name
Investigative Site
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Investigative Site
City
Charlotte
State/Province
North Carolina
Country
United States
Facility Name
Investigative Site
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Investigative site
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Investigative Site
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Investigative Site
City
Easley
State/Province
South Carolina
Country
United States
Facility Name
Investigative Site
City
Gaffney
State/Province
South Carolina
Country
United States
Facility Name
Investigative Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Investigative Site
City
Greer
State/Province
South Carolina
Country
United States
Facility Name
Investigative Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Invesigative Site
City
Union
State/Province
South Carolina
Country
United States
Facility Name
Investigative Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigative Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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

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