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Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

Primary Purpose

Asthma

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 Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria: Persistent bronchial asthma No change in asthma treatment within 4 weeks prior to visit 1 Non-smoker or ex-smoker (for 12 months or longer) Main Exclusion Criteria: Poorly controlled asthma or seasonal asthma History of lower airway infection four weeks prior to visit 1 Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1 Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1 Patients with chronic heart failure Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study

Sites / Locations

  • 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
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma
  • ALTANA Pharma

Outcomes

Primary Outcome Measures

change in lung function from baseline to final visit.

Secondary Outcome Measures

pulmonary function variables
diary variables
quality of life variables
time to first exacerbation
number of asthma exacerbations
safety.

Full Information

First Posted
November 17, 2003
Last Updated
October 24, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00073177
Brief Title
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
Official Title
A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 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 effects of oral roflumilast with placebo on lung function in patients with asthma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Roflumilast
Primary Outcome Measure Information:
Title
change in lung function from baseline to final visit.
Secondary Outcome Measure Information:
Title
pulmonary function variables
Title
diary variables
Title
quality of life variables
Title
time to first exacerbation
Title
number of asthma exacerbations
Title
safety.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Persistent bronchial asthma No change in asthma treatment within 4 weeks prior to visit 1 Non-smoker or ex-smoker (for 12 months or longer) Main Exclusion Criteria: Poorly controlled asthma or seasonal asthma History of lower airway infection four weeks prior to visit 1 Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1 Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1 Patients with chronic heart failure Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study
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 Arkansas
State/Province
Arkansas
Country
United States
Facility Name
ALTANA Pharma
City
Cities in California
State/Province
California
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Colorado
State/Province
Colorado
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 Illinois
State/Province
Illinois
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
Massachusetts
State/Province
Massachusetts
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Michigan
State/Province
Michigan
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Minnesota
State/Province
Minnesota
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Mississippi
State/Province
Mississippi
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Missouri
State/Province
Missouri
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Montana
State/Province
Montana
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 North Dakota
State/Province
North Dakota
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 Tennessee
State/Province
Tennessee
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 Wisconsin
State/Province
Wisconsin
Country
United States
Facility Name
ALTANA Pharma
City
Cities in Argentina
Country
Argentina
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

Citations:
PubMed Identifier
26612545
Citation
Chervinsky P, Meltzer EO, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Safety findings from a pooled analysis of ten clinical studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S28-34. doi: 10.1016/j.pupt.2015.11.003. Epub 2015 Nov 22.
Results Reference
derived
PubMed Identifier
26498386
Citation
Meltzer EO, Chervinsky P, Busse W, Ohta K, Bardin P, Bredenbroker D, Bateman ED. Roflumilast for asthma: Efficacy findings in placebo-controlled studies. Pulm Pharmacol Ther. 2015 Dec;35 Suppl:S20-7. doi: 10.1016/j.pupt.2015.10.006. Epub 2015 Oct 21.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4471&filename=BY217-M2-012-RDS-2007-01-02.pdf
Description
BY217-M2-012-RDS-2007-01-02.pdf

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Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

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