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Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

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

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Roflumilast, COPD, Chronic obstructive pulmonary disease

Eligibility Criteria

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

Main Inclusion Criteria: COPD patients having at least one exacerbation within last year FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) ≤ 50% of predicted Main Exclusion Criteria: COPD exacerbation not resolved at first baseline visit Diagnosis of asthma and/or other relevant lung disease

Sites / Locations

  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Roflumilast

Placebo

Arm Description

500 mcg, once daily, oral administration in the morning

once daily

Outcomes

Primary Outcome Measures

Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
COPD Exacerbation Rate (Moderate or Severe)
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].

Secondary Outcome Measures

Post-bronchodilator FEV1 [L]
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Time to Mortality Due to Any Reason
Natural Log-transformed C-reactive Protein (CRP)
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.

Full Information

First Posted
February 27, 2006
Last Updated
November 29, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00297102
Brief Title
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Official Title
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast. For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

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, COPD, Chronic obstructive pulmonary disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1523 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
500 mcg, once daily, oral administration in the morning
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once daily
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Description
500 mcg, once daily, oral administration in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Description
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Time Frame
Change from baseline over 52 weeks of treatment
Title
COPD Exacerbation Rate (Moderate or Severe)
Description
Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].
Time Frame
52 weeks treatment period
Secondary Outcome Measure Information:
Title
Post-bronchodilator FEV1 [L]
Description
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Time Frame
Change from baseline over 52 weeks of treatment
Title
Time to Mortality Due to Any Reason
Time Frame
52 weeks treatment period
Title
Natural Log-transformed C-reactive Protein (CRP)
Description
Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Time Frame
Change from baseline to last post randomization measurement (52 weeks)
Title
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
Description
The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.
Time Frame
Change from baseline over 52 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: COPD patients having at least one exacerbation within last year FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) ≤ 50% of predicted Main Exclusion Criteria: COPD exacerbation not resolved at first baseline visit Diagnosis of asthma and/or other relevant lung disease
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/Nycomed Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92385
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Palmdale
State/Province
California
ZIP/Postal Code
93551
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33708
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lebanon
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70461
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02777
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63117
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Springfield
State/Province
New Jersey
ZIP/Postal Code
07081
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45241
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
02920
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Charlottesville, VA
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Marietta
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Adelaide South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Box Hill
ZIP/Postal Code
VIC 2138
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Camperdown
ZIP/Postal Code
NSW 2050
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Clayton
ZIP/Postal Code
VIC 3168
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Geelong
ZIP/Postal Code
VIC 3220
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kippa-ring
ZIP/Postal Code
QLD 4021
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nedlands
ZIP/Postal Code
WA 6009
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
South Brisbane
ZIP/Postal Code
QLD 4101
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toorak Gardens
ZIP/Postal Code
SA 5056
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Wayville
ZIP/Postal Code
SA 5034
Country
Australia
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Feldbach
ZIP/Postal Code
8330
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Gänserndorf
ZIP/Postal Code
2230
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hallein
ZIP/Postal Code
5400
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Linz
ZIP/Postal Code
4040
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Natters
ZIP/Postal Code
6161
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Spittal an der Drau
ZIP/Postal Code
9800
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Belo Horizonte - MG CEP
ZIP/Postal Code
30130100
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Botucatu - SP CEP
ZIP/Postal Code
16618000
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Curitiba-PR
ZIP/Postal Code
80060900
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Florianópolis-SC
ZIP/Postal Code
88040970
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Juiz de Fora-MG
ZIP/Postal Code
36036110
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Porto Alegre-RS
ZIP/Postal Code
90035003
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Porto Alegre-RS
ZIP/Postal Code
90610000
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Porto Alegre
ZIP/Postal Code
90035074
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Quadra 605 Brasilia - DF
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Recife - PE
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Rio de Janeiro-RJ
ZIP/Postal Code
21941590
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Santo André-SP
ZIP/Postal Code
9060650
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
São Paulo-SP
ZIP/Postal Code
1221020
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
São Paulo-SP
ZIP/Postal Code
4023062
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
São Paulo-SP
ZIP/Postal Code
5403900
Country
Brazil
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Beuvry
ZIP/Postal Code
62660
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chauny cedex
ZIP/Postal Code
2303
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Clermont-Ferrand Cedex1
ZIP/Postal Code
63003
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ferolles-Attily
ZIP/Postal Code
77150
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Grasse
ZIP/Postal Code
6130
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
La Teste de Buch
ZIP/Postal Code
33260
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lens
ZIP/Postal Code
62307
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Libourne
ZIP/Postal Code
33500
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lille cedex
ZIP/Postal Code
59020
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Marcq en Baroeul
ZIP/Postal Code
59700
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Martigues Cedex
ZIP/Postal Code
13695
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Metz
ZIP/Postal Code
57000
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montigny - Les - Metz
ZIP/Postal Code
57950
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montpellier Cedex
ZIP/Postal Code
34070
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nice
ZIP/Postal Code
6000
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ollioules
ZIP/Postal Code
83190
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Paris Cedex 18
ZIP/Postal Code
75877
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Perpignan Cedex
ZIP/Postal Code
66046
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saint Laurent Du Var
ZIP/Postal Code
6700
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saint-Etienne
ZIP/Postal Code
42000
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saint-Quentin
ZIP/Postal Code
2100
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toulon
ZIP/Postal Code
83000
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Vieux Conde
ZIP/Postal Code
59690
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Deggendorf
ZIP/Postal Code
94469
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fulda
ZIP/Postal Code
36039
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Schwetzingen
ZIP/Postal Code
68723
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Budapest
ZIP/Postal Code
1221
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Budapest
ZIP/Postal Code
1475
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Debrecen
ZIP/Postal Code
4043
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mosdós
ZIP/Postal Code
7257
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nyiregyháza
ZIP/Postal Code
4412
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pécs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tapolca
ZIP/Postal Code
8300
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tauranga
ZIP/Postal Code
3001
Country
New Zealand
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bucharest
ZIP/Postal Code
11025
Country
Romania
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bucharest
ZIP/Postal Code
20125
Country
Romania
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bucharest
ZIP/Postal Code
21659
Country
Romania
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bucharest
ZIP/Postal Code
30303
Country
Romania
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bucharest
ZIP/Postal Code
50159
Country
Romania
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
10100
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
109240
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
111020
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
118089
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Moscow
ZIP/Postal Code
143405
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Petersburg
ZIP/Postal Code
193015
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Petersburg
ZIP/Postal Code
196211
Country
Russian Federation
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Baillieston, Glasgow
ZIP/Postal Code
G69 7AD
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bangor, Northern Ireland
ZIP/Postal Code
BT19 1PP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bath, Avon
ZIP/Postal Code
BA2 3HT
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bath
ZIP/Postal Code
BA1 2SR
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Belfast
ZIP/Postal Code
BT4 1NT
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Co. Antrim
ZIP/Postal Code
BT38 8TP
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cottingham, E York
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
County Antrim
ZIP/Postal Code
BT37 9QN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Downpatrick, Northern Ireland
ZIP/Postal Code
BT30 6HY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
East Sussex
ZIP/Postal Code
TN39 5HE
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fife
ZIP/Postal Code
KY12 8SJ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Glasgow
ZIP/Postal Code
G45 9AW
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Glasgow
ZIP/Postal Code
G46 8NY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Glengormley Newtownabbey
ZIP/Postal Code
BT36 5EQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Harrow
ZIP/Postal Code
HA3 7LT
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Kent
ZIP/Postal Code
CT5 1BZ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Leamington Spa
ZIP/Postal Code
CV324RA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Randalstown
ZIP/Postal Code
BT41 3AE
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sheffield
ZIP/Postal Code
S39DA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Solihull
ZIP/Postal Code
B91 2JL
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Southdown, Bath
ZIP/Postal Code
BA2 1NH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sunbury on Thames, Middlesex
ZIP/Postal Code
TW16 6RH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Vale of Glamorgan
ZIP/Postal Code
CF64 2XX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19716960
Citation
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum In: Lancet. 2010 Oct 2;376(9747):1146.
Results Reference
result
PubMed Identifier
28419462
Citation
Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
Results Reference
derived
PubMed Identifier
24120253
Citation
Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
Results Reference
derived
PubMed Identifier
23117188
Citation
Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.
Results Reference
derived
PubMed Identifier
20102307
Citation
Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
Results Reference
derived

Learn more about this trial

Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

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