search
Back to results

Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Roflumilast
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease) Currently stable COPD with no change in COPD treatment in the prior 4 weeks Main Exclusion Criteria: Clinical diagnosis of asthma Poorly controlled COPD Regular need for daily oxygen therapy

Sites / Locations

  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ATLANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma

Outcomes

Primary Outcome Measures

pulmonary function.

Secondary Outcome Measures

exacerbation rate
quality of life
symptoms
use of rescue medication
safety and tolerability.

Full Information

First Posted
June 9, 2003
Last Updated
November 22, 2016
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00062582
Brief Title
Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)
Official Title
A 24 Week, Placebo-Controlled, Randomized, Parallel Group Study Comparing Roflumilast 500 mcg Daily vs Placebo on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients 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, COPD
Keywords
Roflumilast, Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
1000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
pulmonary function.
Secondary Outcome Measure Information:
Title
exacerbation rate
Title
quality of life
Title
symptoms
Title
use of rescue medication
Title
safety and tolerability.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Clinical diagnosis of COPD (Chronic Obstructive Pulmonary Disease) Currently stable COPD with no change in COPD treatment in the prior 4 weeks Main Exclusion Criteria: Clinical diagnosis of asthma Poorly controlled COPD Regular need for daily oxygen therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
ALTANA Pharma
City
Cities in Alabama
State/Province
Alabama
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Arizona
State/Province
Arizona
Country
United States
Facility Name
ALTANA Pharma
City
Cities in California
State/Province
California
Country
United States
Facility Name
ATLANA Pharma
City
Cities in Colorado
State/Province
Colorado
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Conneticut
State/Province
Connecticut
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Delaware
State/Province
Delaware
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Florida
State/Province
Florida
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Georgia
State/Province
Georgia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Idaho
State/Province
Idaho
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Indiana
State/Province
Indiana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Iowa
State/Province
Iowa
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Kansas
State/Province
Kansas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Kentucky
State/Province
Kentucky
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Louisiana
State/Province
Louisiana
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Maryland
State/Province
Maryland
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Michigan
State/Province
Michigan
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Missouri
State/Province
Missouri
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Nebraska
State/Province
Nebraska
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Nevada
State/Province
Nevada
Country
United States
Facility Name
ALTANA Pharma
City
Cities in New Jersey
State/Province
New Jersey
Country
United States
Facility Name
ALTANA Pharma
City
Cities in New York
State/Province
New York
Country
United States
Facility Name
ALTANA Pharma
City
Cities in North Carolina
State/Province
North Carolina
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Ohio
State/Province
Ohio
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Oregon
State/Province
Oregon
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Pennsylvania
State/Province
Pennsylvania
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Rhode Island
State/Province
Rhode Island
Country
United States
Facility Name
ALTANA Pharma
City
Cities in South Carolina
State/Province
South Carolina
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Texas
State/Province
Texas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Utah
State/Province
Utah
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Virginia
State/Province
Virginia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Washington
State/Province
Washington
Country
United States
Facility Name
ALTANA Pharma
City
Cities in West Virginia
State/Province
West Virginia
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Argentina
Country
Argentina
Facility Name
ALTANA Pharma
City
Cities in Canada
Country
Canada
Facility Name
ALTANA Pharma
City
Cities in Colombia
Country
Colombia
Facility Name
ALTANA Pharma
City
Cities in Mexico
Country
Mexico
Facility Name
ALTANA Pharma
City
Cities in Peru
Country
Peru

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4475&filename=BY217-M2-110-RDS-2006-07-27.pdf
Description
BY217-M2-110-RDS-2006-07-27.pdf

Learn more about this trial

Effect of Roflumilast on Pulmonary Function and Respiratory Symptoms in Patients With Chronic Obstructive Pulmonary Disease (COPD) (BY217/M2-110)

We'll reach out to this number within 24 hrs