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Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127) (EOS)

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, Salmeterol, COPD, Chronic obstructive pulmonary disease

Eligibility Criteria

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

Main Inclusion Criteria: History of COPD for at least 12 months prior to baseline visit FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted Main Exclusion Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit

Sites / Locations

  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Sites
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
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  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site
  • Altana Pharma/Nycomed Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Roflumilast

Placebo

Arm Description

Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled

Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled

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]

Secondary Outcome Measures

Post-bronchodilator FEV1
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
COPD Exacerbation Rate (Mild, Moderate or Severe)
Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or 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 [ATS / ERS 2005].
Transition Dyspnea Index (TDI) Focal Score
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.
Shortness of Breath Questionnaire (SOBQ) Total Score
Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".

Full Information

First Posted
April 11, 2006
Last Updated
November 1, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00313209
Brief Title
Effect of Roflumilast on Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)
Acronym
EOS
Official Title
Effect of Roflumilast in COPD Patients Treated With Salmeterol. A 24-week, Double-blind Study With 500 μg Roflumilast Once Daily Versus Placebo. The EOS Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
February 2008 (Actual)

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 efficacy of roflumilast on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of salmeterol. The study duration will last up to 28 weeks. The study will provide further data on safety and tolerability of roflumilast.

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, Salmeterol, 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
933 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
Roflumilast 500 µg underlying medication: salmeterol 50 μg, twice daily, inhaled
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo underlying medication: salmeterol 50 μg, twice daily, inhaled
Intervention Type
Drug
Intervention Name(s)
Roflumilast
Intervention Description
500 µg, 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 24 weeks of treatment
Secondary Outcome Measure Information:
Title
Post-bronchodilator FEV1
Description
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Time Frame
Change from baseline over 24 weeks of treatment
Title
COPD Exacerbation Rate (Mild, Moderate or Severe)
Description
Mean rate of COPD exacerbations requiring rescue medication of 3 or more puffs/day on at least 2 consecutive days (=mild COPD exacerbations), or 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 [ATS / ERS 2005].
Time Frame
24 weeks treatment period
Title
Transition Dyspnea Index (TDI) Focal Score
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 24 weeks of treatment
Title
Shortness of Breath Questionnaire (SOBQ) Total Score
Description
Mean change from baseline during the treatment period in SOBQ. This is a 24-item measure that assesses self-reported shortness of breath while performing a variety of activities of daily living. The questions were administered at visits V0, V2, V3, V4, V5, V6 and Vend to assess the perceived shortness of breath of the patient. For each activity listed in the questionnaire the patient should rate his/her breathlessness on a scale between zero and five, where zero is "not at all breathless" and five is "maximally breathless or too breathless to do the activity".
Time Frame
Change from baseline over 24 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: History of COPD for at least 12 months prior to baseline visit FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted Main Exclusion Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticosteroids and/or antibiotics not stopped at least 4 weeks prior to baseline visit
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
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Neusiedl/See
ZIP/Postal Code
7100
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Perg
ZIP/Postal Code
4320
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
St. Pölten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Steyr
ZIP/Postal Code
4400
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Wiener Neustadt
ZIP/Postal Code
2700
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Wien
ZIP/Postal Code
1030
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Wien
ZIP/Postal Code
1150
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Zwettl
ZIP/Postal Code
3910
Country
Austria
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bruxelles
ZIP/Postal Code
1040
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Halen
ZIP/Postal Code
3545
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Jette
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Malmedy
ZIP/Postal Code
4960
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montigny-Le-Tilleul
ZIP/Postal Code
6110
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Veurne
ZIP/Postal Code
8630
Country
Belgium
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ajax, Ontario
ZIP/Postal Code
L1S 2J7
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Halifax, N.S.
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hamilton, Ontario
ZIP/Postal Code
L8N3Z5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hamilton
ZIP/Postal Code
L8N4A6
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Laval
ZIP/Postal Code
H7V3Y7
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
London
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mirabel
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montreal, PQ
ZIP/Postal Code
H2X2P4
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montreal
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Montreal
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
New Market, ON
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
North Bay
ZIP/Postal Code
P1B2H3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ontario
ZIP/Postal Code
L4C3Y1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ottawa
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Quebec City
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Regina, Saskatchewan
ZIP/Postal Code
S4P 1Z7
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saint John
ZIP/Postal Code
E2K2T8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sainte-Foy, Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saskatoon SK
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sherbrooke, PQ
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toronto, ON
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Toronto, ON
ZIP/Postal Code
M5T 3A9
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Vancouver, BC
ZIP/Postal Code
V6S 3J5
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Windsor
ZIP/Postal Code
N8X 3V6
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Winnipeg MB
ZIP/Postal Code
R2K 3S8
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Woodstock
ZIP/Postal Code
N4S 4G3
Country
Canada
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Beausoleil
ZIP/Postal Code
6240
Country
France
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
Grasse
ZIP/Postal Code
6130
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lille Cedex
ZIP/Postal Code
59037
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
Martigues Cedex
ZIP/Postal Code
13695
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
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nice Cedex 1
ZIP/Postal Code
6002
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
Saint Laurent Du Var
ZIP/Postal Code
6700
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
Trelaze
ZIP/Postal Code
49800
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Aschaffenburg
ZIP/Postal Code
63739
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bonn
ZIP/Postal Code
53119
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Geesthacht
ZIP/Postal Code
21502
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hannover
ZIP/Postal Code
30167
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Köln
ZIP/Postal Code
51069
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
Saarbruecken
ZIP/Postal Code
66111
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
Sinsheim
ZIP/Postal Code
74889
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Surwold
ZIP/Postal Code
26903
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Witten
ZIP/Postal Code
58452
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Würzburg
ZIP/Postal Code
97070
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bologna
ZIP/Postal Code
48138
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Catania
ZIP/Postal Code
95125
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cisanello (PI)
ZIP/Postal Code
56100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Genova
ZIP/Postal Code
16100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Livorno
ZIP/Postal Code
57124
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Roma
ZIP/Postal Code
156
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saluzzo (CN)
ZIP/Postal Code
12037
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tradate (VA)
ZIP/Postal Code
21049
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Verona
ZIP/Postal Code
30012
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Vittorio Veneto (TV)
ZIP/Postal Code
31029
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Alkmaar
ZIP/Postal Code
1815 JD
Country
Netherlands
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Schiedam
ZIP/Postal Code
3116 BA
Country
Netherlands
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Zwolle
ZIP/Postal Code
8011 JW
Country
Netherlands
Facility Name
Altana Pharma/Nycomed Investigational Sites
City
Kapstadt
Country
South Africa
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Alicante
ZIP/Postal Code
3550
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Barcelona
ZIP/Postal Code
8017
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Barcelona
ZIP/Postal Code
8023
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Barcelona
ZIP/Postal Code
8222
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Elche (Alicante)
ZIP/Postal Code
3202
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Fuentesnuevas, Ponferrada (León)
ZIP/Postal Code
24411
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Laredo (Cantabria)
ZIP/Postal Code
39770
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mataró, Barcelona
ZIP/Postal Code
8303
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Petrer (Alicante)
ZIP/Postal Code
3610
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sabadell
ZIP/Postal Code
8208
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Tarrasa (Barcelona)
ZIP/Postal Code
8221
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Torrelavega (Cantabria)
ZIP/Postal Code
39300
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Belfast
ZIP/Postal Code
BT14 6AB
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Belfast
ZIP/Postal Code
BT15 2GE
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Belfast
ZIP/Postal Code
BT7 1DA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bexhill-on-Sea, East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bradford on Avon, Wiltshire
ZIP/Postal Code
BA15 1DQ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bradford
ZIP/Postal Code
BD157NJ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chesterfield Derbyshire
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Coleraine
ZIP/Postal Code
BT52 1HS
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cookstown
ZIP/Postal Code
BT80 8BG
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
Edinburg
ZIP/Postal Code
EH8 9AG
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Glasgow
ZIP/Postal Code
G3 8YJ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hastings
ZIP/Postal Code
TN34 3EY
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Middlessex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sunbury on Thames, Middlessex
ZIP/Postal Code
TW16 6RH
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Watford
ZIP/Postal Code
WD25 0EA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
19716961
Citation
Fabbri LM, Calverley PM, Izquierdo-Alonso JL, Bundschuh DS, Brose M, Martinez FJ, Rabe KF; M2-127 and M2-128 study groups. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):695-703. doi: 10.1016/S0140-6736(09)61252-6.
Results Reference
result
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 Lung Function in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Salmeterol: The EOS Study (BY217/M2-127)

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