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Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128) (HELIOS)

Primary Purpose

Chronic Obstructive Pulmonary Disease

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 focused on measuring COPD, Roflumilast

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 and chronic productive cough for 3 months in each of the 2 years prior to baseline visit
  • FEV1/FVC ratio (post-bronchodilator) ≤ 70%
  • FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted
  • Treated with tiotropium for at least 3 months before enrollment
  • At least 28 puffs of rescue medication during last week prior to randomization

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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

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: tiotropium 18 µg, once daily, inhaled

Placebo underlying medication: tiotropium 18 µg, once 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 (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].
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
January 18, 2007
Last Updated
October 24, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00424268
Brief Title
Effect of Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)
Acronym
HELIOS
Official Title
Effect of Roflumilast in COPD Patients Treated With Tiotropium. A 24-week, Double-blind Study With 500 µg Roflumilast Once Daily Versus Placebo. The HELIOS Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
July 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 compare the efficacy of roflumilast to placebo on pulmonary function and symptomatic parameters in patients with chronic obstructive pulmonary disease (COPD) during concomitant administration of tiotropium. 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
Keywords
COPD, Roflumilast

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Roflumilast
Arm Type
Active Comparator
Arm Description
Roflumilast 500 µg underlying medication: tiotropium 18 µg, once daily, inhaled
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo underlying medication: tiotropium 18 µg, once 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 (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
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 and chronic productive cough for 3 months in each of the 2 years prior to baseline visit FEV1/FVC ratio (post-bronchodilator) ≤ 70% FEV1 (post-bronchodilator) between ≥ 40% and ≤ 70% of predicted Treated with tiotropium for at least 3 months before enrollment At least 28 puffs of rescue medication during last week prior to randomization 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
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
Linz
ZIP/Postal Code
4040
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
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
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
Montigny-Les-Metz
ZIP/Postal Code
57950
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
ZIP/Postal Code
6000
Country
France
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Nimes Cedex 9
ZIP/Postal Code
30029
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
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-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
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Dortmund
ZIP/Postal Code
44263
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
Göppingen
ZIP/Postal Code
73033
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
Landsberg/Lech
ZIP/Postal Code
86899
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Leonberg
ZIP/Postal Code
71229
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
Saarbrücken
ZIP/Postal Code
66111
Country
Germany
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Saarlouis
ZIP/Postal Code
66740
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
Weyhe
ZIP/Postal Code
28844
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
Budapest
ZIP/Postal Code
1046
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
1529
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Cegled
ZIP/Postal Code
2700
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Csorna
ZIP/Postal Code
9300
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Erd
ZIP/Postal Code
2030
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Györ
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Hódmezovásárhely
ZIP/Postal Code
6800
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Matrahaza
ZIP/Postal Code
3233
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
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Szolnok
ZIP/Postal Code
5006
Country
Hungary
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bassano Del Grappa (VI)
ZIP/Postal Code
36061
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
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Genova
ZIP/Postal Code
16132
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
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pavullo nel Frignano (MO)
ZIP/Postal Code
41020
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
Reggio Emilia
ZIP/Postal Code
42100
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
Alicante
ZIP/Postal Code
3010
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Baracaldo (Vizcaya)
ZIP/Postal Code
48903
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Candia
ZIP/Postal Code
28935
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Escaldes-Engordany
ZIP/Postal Code
AD700
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Galdakao
ZIP/Postal Code
48960
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
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
La Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Madrid
ZIP/Postal Code
28047
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Mostoles Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Pozuelo de Alarcón
ZIP/Postal Code
28223
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Requena
ZIP/Postal Code
46340
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sant Cugat del Valles
ZIP/Postal Code
8190
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Santa Cruz de Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Valencia
ZIP/Postal Code
46017
Country
Spain
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Ashford
ZIP/Postal Code
TW15 3RN
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Atherstone, Warwick
ZIP/Postal Code
CV9 1EU
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Barry
ZIP/Postal Code
CS62 7EB
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
Bolton Lancs
ZIP/Postal Code
BL3 6TL
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Bolton
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
Chesterfield
ZIP/Postal Code
S40 4TF
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Chippenham
ZIP/Postal Code
SN15 1HP
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
Darlington, Co. Durham
ZIP/Postal Code
DL3 6HX
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
Glasgow
ZIP/Postal Code
G45 9AW
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
Keresely End, Coventry
ZIP/Postal Code
CV7 8LA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Plymouth
ZIP/Postal Code
PL6 7TH
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
Swindon, Wilts
ZIP/Postal Code
SN25 4YZ
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Trowbridge
ZIP/Postal Code
BA14 9AR
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Watford
ZIP/Postal Code
WD25 0EA
Country
United Kingdom
Facility Name
Altana Pharma/Nycomed Investigational Site
City
Yaxley
ZIP/Postal Code
PE7 3JL
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 in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Tiotropium: The HELIOS Study (BY217/M2-128)

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