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

November 1, 2016 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

933

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Altana Pharma/Nycomed Investigational Site
      • Neusiedl/See, Austria, 7100
        • Altana Pharma/Nycomed Investigational Site
      • Perg, Austria, 4320
        • Altana Pharma/Nycomed Investigational Site
      • Salzburg, Austria, 5020
        • Altana Pharma/Nycomed Investigational Site
      • St. Pölten, Austria, 3100
        • Altana Pharma/Nycomed Investigational Site
      • Steyr, Austria, 4400
        • Altana Pharma/Nycomed Investigational Site
      • Wien, Austria, 1030
        • Altana Pharma/Nycomed Investigational Site
      • Wien, Austria, 1140
        • Altana Pharma/Nycomed Investigational Site
      • Wien, Austria, 1150
        • Altana Pharma/Nycomed Investigational Site
      • Wiener Neustadt, Austria, 2700
        • Altana Pharma/Nycomed Investigational Site
      • Zwettl, Austria, 3910
        • Altana Pharma/Nycomed Investigational Site
  • Belgium
      • Arlon, Belgium, 6700
        • Altana Pharma/Nycomed Investigational Site
      • Bruxelles, Belgium, 1000
        • Altana Pharma/Nycomed Investigational Site
      • Bruxelles, Belgium, 1040
        • Altana Pharma/Nycomed Investigational Site
      • Duffel, Belgium, 2570
        • Altana Pharma/Nycomed Investigational Site
      • Genk, Belgium, 3600
        • Altana Pharma/Nycomed Investigational Site
      • Gilly, Belgium, 6060
        • Altana Pharma/Nycomed Investigational Site
      • Halen, Belgium, 3545
        • Altana Pharma/Nycomed Investigational Site
      • Jette, Belgium, 1090
        • Altana Pharma/Nycomed Investigational Site
      • Leuven, Belgium, 3000
        • Altana Pharma/Nycomed Investigational Site
      • Liège, Belgium, 4000
        • Altana Pharma/Nycomed Investigational Site
      • Malmedy, Belgium, 4960
        • Altana Pharma/Nycomed Investigational Site
      • Montigny-Le-Tilleul, Belgium, 6110
        • Altana Pharma/Nycomed Investigational Site
      • Namur, Belgium, 5000
        • Altana Pharma/Nycomed Investigational Site
      • Veurne, Belgium, 8630
        • Altana Pharma/Nycomed Investigational Site
  • Canada
      • Ajax, Ontario, Canada, L1S 2J7
        • Altana Pharma/Nycomed Investigational Site
      • Halifax, N.S., Canada, B3H 3A7
        • Altana Pharma/Nycomed Investigational Site
      • Hamilton, Canada, L8N4A6
        • Altana Pharma/Nycomed Investigational Site
      • Hamilton, Ontario, Canada, L8N3Z5
        • Altana Pharma/Nycomed Investigational Site
      • Laval, Canada, H7V3Y7
        • Altana Pharma/Nycomed Investigational Site
      • London, Canada, N6A 5R9
        • Altana Pharma/Nycomed Investigational Site
      • Mirabel, Canada, J7J 2K8
        • Altana Pharma/Nycomed Investigational Site
      • Montreal, Canada, H2L 4M1
        • Altana Pharma/Nycomed Investigational Site
      • Montreal, Canada, H4J 1C5
        • Altana Pharma/Nycomed Investigational Site
      • Montreal, PQ, Canada, H2X2P4
        • Altana Pharma/Nycomed Investigational Site
      • New Market, ON, Canada, L3Y 5G8
        • Altana Pharma/Nycomed Investigational Site
      • North Bay, Canada, P1B2H3
        • Altana Pharma/Nycomed Investigational Site
      • Ontario, Canada, L4C3Y1
        • Altana Pharma/Nycomed Investigational Site
      • Ottawa, Canada, K1Y 4G2
        • Altana Pharma/Nycomed Investigational Site
      • Quebec City, Canada, G8T 7A1
        • Altana Pharma/Nycomed Investigational Site
      • Regina, Saskatchewan, Canada, S4P 1Z7
        • Altana Pharma/Nycomed Investigational Site
      • Saint John, Canada, E2K2T8
        • Altana Pharma/Nycomed Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V4G5
        • Altana Pharma/Nycomed Investigational Site
      • Saskatoon SK, Canada, S7N 0W8
        • Altana Pharma/Nycomed Investigational Site
      • Sherbrooke, PQ, Canada, J1H 5N4
        • Altana Pharma/Nycomed Investigational Site
      • Toronto, ON, Canada, M5B 1W8
        • Altana Pharma/Nycomed Investigational Site
      • Toronto, ON, Canada, M5T 3A9
        • Altana Pharma/Nycomed Investigational Site
      • Vancouver, BC, Canada, V6S 3J5
        • Altana Pharma/Nycomed Investigational Site
      • Windsor, Canada, N8X 3V6
        • Altana Pharma/Nycomed Investigational Site
      • Winnipeg MB, Canada, R2K 3S8
        • Altana Pharma/Nycomed Investigational Site
      • Woodstock, Canada, N4S 4G3
        • Altana Pharma/Nycomed Investigational Site
  • France
      • Beausoleil, France, 6240
        • Altana Pharma/Nycomed Investigational Site
      • Beuvry, France, 62660
        • Altana Pharma/Nycomed Investigational Site
      • Chauny Cedex, France, 2303
        • Altana Pharma/Nycomed Investigational Site
      • Grasse, France, 6130
        • Altana Pharma/Nycomed Investigational Site
      • Grenoble, France, 38100
        • Altana Pharma/Nycomed Investigational Site
      • Lille Cedex, France, 59037
        • Altana Pharma/Nycomed Investigational Site
      • Lyon, France, 69003
        • Altana Pharma/Nycomed Investigational Site
      • Martigues Cedex, France, 13695
        • Altana Pharma/Nycomed Investigational Site
      • Montpellier Cedex, France, 34070
        • Altana Pharma/Nycomed Investigational Site
      • Nantes, France, 44000
        • Altana Pharma/Nycomed Investigational Site
      • Nice, France, 6000
        • Altana Pharma/Nycomed Investigational Site
      • Nice Cedex 1, France, 6002
        • Altana Pharma/Nycomed Investigational Site
      • Nimes, France, 30900
        • Altana Pharma/Nycomed Investigational Site
      • Saint Laurent Du Var, France, 6700
        • Altana Pharma/Nycomed Investigational Site
      • Saint-Quentin, France, 2100
        • Altana Pharma/Nycomed Investigational Site
      • Trelaze, France, 49800
        • Altana Pharma/Nycomed Investigational Site
  • Germany
      • Aschaffenburg, Germany, 63739
        • Altana Pharma/Nycomed Investigational Site
      • Bochum, Germany, 44787
        • Altana Pharma/Nycomed Investigational Site
      • Bonn, Germany, 53119
        • Altana Pharma/Nycomed Investigational Site
      • Geesthacht, Germany, 21502
        • Altana Pharma/Nycomed Investigational Site
      • Gelnhausen, Germany, 63571
        • Altana Pharma/Nycomed Investigational Site
      • Großhansdorf, Germany, 22927
        • Altana Pharma/Nycomed Investigational Site
      • Hannover, Germany, 30167
        • Altana Pharma/Nycomed Investigational Site
      • Koblenz, Germany, 56068
        • Altana Pharma/Nycomed Investigational Site
      • Köln, Germany, 51069
        • Altana Pharma/Nycomed Investigational Site
      • Marburg, Germany, 35037
        • Altana Pharma/Nycomed Investigational Site
      • Saarbruecken, Germany, 66111
        • Altana Pharma/Nycomed Investigational Site
      • Schwetzingen, Germany, 68723
        • Altana Pharma/Nycomed Investigational Site
      • Sinsheim, Germany, 74889
        • Altana Pharma/Nycomed Investigational Site
      • Surwold, Germany, 26903
        • Altana Pharma/Nycomed Investigational Site
      • Witten, Germany, 58452
        • Altana Pharma/Nycomed Investigational Site
      • Würzburg, Germany, 97070
        • Altana Pharma/Nycomed Investigational Site
  • Italy
      • Bari, Italy, 70124
        • Altana Pharma/Nycomed Investigational Site
      • Bologna, Italy, 48138
        • Altana Pharma/Nycomed Investigational Site
      • Catania, Italy, 95125
        • Altana Pharma/Nycomed Investigational Site
      • Cisanello (PI), Italy, 56100
        • Altana Pharma/Nycomed Investigational Site
      • Genova, Italy, 16100
        • Altana Pharma/Nycomed Investigational Site
      • Livorno, Italy, 57124
        • Altana Pharma/Nycomed Investigational Site
      • Milano, Italy, 20153
        • Altana Pharma/Nycomed Investigational Site
      • Pordenone, Italy, 33170
        • Altana Pharma/Nycomed Investigational Site
      • Roma, Italy, 156
        • Altana Pharma/Nycomed Investigational Site
      • Saluzzo (CN), Italy, 12037
        • Altana Pharma/Nycomed Investigational Site
      • Torino, Italy, 10126
        • Altana Pharma/Nycomed Investigational Site
      • Tradate (VA), Italy, 21049
        • Altana Pharma/Nycomed Investigational Site
      • Verona, Italy, 30012
        • Altana Pharma/Nycomed Investigational Site
      • Vittorio Veneto (TV), Italy, 31029
        • Altana Pharma/Nycomed Investigational Site
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • Altana Pharma/Nycomed Investigational Site
      • Almelo, Netherlands, 7609 PP
        • Altana Pharma/Nycomed Investigational Site
      • Eindhoven, Netherlands, 5623 EJ
        • Altana Pharma/Nycomed Investigational Site
      • Helmond, Netherlands, 5707 HA
        • Altana Pharma/Nycomed Investigational Site
      • Schiedam, Netherlands, 3116 BA
        • Altana Pharma/Nycomed Investigational Site
      • Zwolle, Netherlands, 8011 JW
        • Altana Pharma/Nycomed Investigational Site
  • South Africa
      • Kapstadt, South Africa
        • Altana Pharma/Nycomed Investigational Sites
  • Spain
      • Alicante, Spain, 3550
        • Altana Pharma/Nycomed Investigational Site
      • Barcelona, Spain, 8017
        • Altana Pharma/Nycomed Investigational Site
      • Barcelona, Spain, 8023
        • Altana Pharma/Nycomed Investigational Site
      • Barcelona, Spain, 8025
        • Altana Pharma/Nycomed Investigational Site
      • Barcelona, Spain, 8222
        • Altana Pharma/Nycomed Investigational Site
      • Elche (Alicante), Spain, 3202
        • Altana Pharma/Nycomed Investigational Site
      • Fuentesnuevas, Ponferrada (León), Spain, 24411
        • Altana Pharma/Nycomed Investigational Site
      • Guadalajara, Spain, 19002
        • Altana Pharma/Nycomed Investigational Site
      • Laredo (Cantabria), Spain, 39770
        • Altana Pharma/Nycomed Investigational Site
      • Mataró, Barcelona, Spain, 8303
        • Altana Pharma/Nycomed Investigational Site
      • Petrer (Alicante), Spain, 3610
        • Altana Pharma/Nycomed Investigational Site
      • Sabadell, Spain, 8208
        • Altana Pharma/Nycomed Investigational Site
      • Tarrasa (Barcelona), Spain, 8221
        • Altana Pharma/Nycomed Investigational Site
      • Torrelavega (Cantabria), Spain, 39300
        • Altana Pharma/Nycomed Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT14 6AB
        • Altana Pharma/Nycomed Investigational Site
      • Belfast, United Kingdom, BT15 2GE
        • Altana Pharma/Nycomed Investigational Site
      • Belfast, United Kingdom, BT7 1DA
        • Altana Pharma/Nycomed Investigational Site
      • Bexhill-on-Sea, East Sussex, United Kingdom, TN40 1JJ
        • Altana Pharma/Nycomed Investigational Site
      • Bradford, United Kingdom, BD157NJ
        • Altana Pharma/Nycomed Investigational Site
      • Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
        • Altana Pharma/Nycomed Investigational Site
      • Chesterfield Derbyshire, United Kingdom, S40 4TF
        • Altana Pharma/Nycomed Investigational Site
      • Coleraine, United Kingdom, BT52 1HS
        • Altana Pharma/Nycomed Investigational Site
      • Cookstown, United Kingdom, BT80 8BG
        • Altana Pharma/Nycomed Investigational Site
      • East Sussex, United Kingdom, TN39 5HE
        • Altana Pharma/Nycomed Investigational Site
      • Edinburg, United Kingdom, EH8 9AG
        • Altana Pharma/Nycomed Investigational Site
      • Glasgow, United Kingdom, G3 8YJ
        • Altana Pharma/Nycomed Investigational Site
      • Hastings, United Kingdom, TN34 3EY
        • Altana Pharma/Nycomed Investigational Site
      • Middlessex, United Kingdom, HA6 2RN
        • Altana Pharma/Nycomed Investigational Site
      • Sunbury on Thames, Middlessex, United Kingdom, TW16 6RH
        • Altana Pharma/Nycomed Investigational Site
      • Watford, United Kingdom, WD25 0EA
        • Altana Pharma/Nycomed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Roflumilast

Roflumilast 500 µg

underlying medication: salmeterol 50 μg, twice daily, inhaled
Drug: Roflumilast
500 µg, once daily, oral administration in the morning
Placebo Comparator: Placebo

Placebo

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
Time Frame: Change from baseline over 24 weeks of treatment
Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]
Change from baseline over 24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-bronchodilator FEV1
Time Frame: Change from baseline over 24 weeks of treatment
Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]
Change from baseline over 24 weeks of treatment
COPD Exacerbation Rate (Mild, Moderate or Severe)
Time Frame: 24 weeks treatment period
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].
24 weeks treatment period
Transition Dyspnea Index (TDI) Focal Score
Time Frame: Change from baseline over 24 weeks of treatment
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.
Change from baseline over 24 weeks of treatment
Shortness of Breath Questionnaire (SOBQ) Total Score
Time Frame: Change from baseline over 24 weeks of treatment
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".
Change from baseline over 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 11, 2006

First Submitted That Met QC Criteria

April 11, 2006

First Posted (Estimate)

April 12, 2006

Study Record Updates

Last Update Posted (Estimate)

December 14, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BY217/M2-127
  • 2005-005080-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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