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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00313209
First received: April 11, 2006
Last updated: May 4, 2012
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Roflumilast
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]


Secondary Outcome Measures:
  • Post-bronchodilator FEV1 [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]
    Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]

  • COPD Exacerbation Rate (Mild, Moderate or Severe) [ Time Frame: 24 weeks treatment period ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]

    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 [ Time Frame: Change from baseline over 24 weeks of treatment ] [ Designated as safety issue: No ]

    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".



Enrollment: 933
Study Start Date: April 2006
Study Completion Date: February 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313209

  Hide Study Locations
Locations
Austria
Altana Pharma/Nycomed Investigational Site
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, 1150
Altana Pharma/Nycomed Investigational Site
Wien, Austria, 1140
Altana Pharma/Nycomed Investigational Site
Wiener Neustadt, Austria, 2700
Altana Pharma/Nycomed Investigational Site
Zwettl, Austria, 3910
Belgium
Altana Pharma/Nycomed Investigational Site
Arlon, Belgium, 6700
Altana Pharma/Nycomed Investigational Site
Bruxelles, Belgium, 1040
Altana Pharma/Nycomed Investigational Site
Bruxelles, Belgium, 1000
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
Canada
Altana Pharma/Nycomed Investigational Site
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
France
Altana Pharma/Nycomed Investigational Site
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
Germany
Altana Pharma/Nycomed Investigational Site
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
Italy
Altana Pharma/Nycomed Investigational Site
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
Netherlands
Altana Pharma/Nycomed Investigational Site
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
South Africa
Altana Pharma/Nycomed Investigational Sites
Kapstadt, South Africa
Spain
Altana Pharma/Nycomed Investigational Site
Alicante, Spain, 3550
Altana Pharma/Nycomed Investigational Site
Barcelona, Spain, 8025
Altana Pharma/Nycomed Investigational Site
Barcelona, Spain, 8222
Altana Pharma/Nycomed Investigational Site
Barcelona, Spain, 8017
Altana Pharma/Nycomed Investigational Site
Barcelona, Spain, 8023
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
United Kingdom
Altana Pharma/Nycomed Investigational Site
Belfast, United Kingdom, BT15 2GE
Altana Pharma/Nycomed Investigational Site
Belfast, United Kingdom, BT14 6AB
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
Sponsors and Collaborators
Takeda
Investigators
Principal Investigator: José L Izquierdo, MD Servicio de Neumología, Hospital General Universitario De Guadalajara, Espana
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nycomed
ClinicalTrials.gov Identifier: NCT00313209     History of Changes
Other Study ID Numbers: BY217/M2-127, 2005-005080-28
Study First Received: April 11, 2006
Results First Received: March 17, 2011
Last Updated: May 4, 2012
Health Authority: Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Takeda:
Roflumilast
Salmeterol
COPD
Chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014