Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The HERMES Study

The aim of the study is to compare 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 be 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).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: Roflumilast

• Study Type: Interventional
• Enrollment (Actual): 1568
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Antigonish, Canada, B2G2C2
    • Altana Pharma/Nycomed Investigational Site
  • Bridgewater, Canada, B4V3N2
    • Altana Pharma/Nycomed Investigational Site
  • Calgary, Canada, T1Y6J4
    • Altana Pharma/Nycomed Investigational Site
  • Corunna, Canada, N0N1G0
    • Altana Pharma/Nycomed Investigational Site
  • Edmonton, Canada, T5N4L8
    • Altana Pharma/Nycomed Investigational Site
  • Fort Erie, Canada, L2A1Z3
    • Altana Pharma/Nycomed Investigational Site
  • Grimsby, Canada, L3M1P3
    • Altana Pharma/Nycomed Investigational Site
  • Hamilton, Canada, L8N3Z5
    • Altana Pharma/Nycomed Investigational Site
  • Longueuil, Canada, J4N1E1
    • Altana Pharma/Nycomed Investigational Site
  • Montreal, Canada, H2L2W5
    • Altana Pharma/Nycomed Investigational Site
  • Ontario, Canada, L2R2Z9
    • Altana Pharma/Nycomed Investigational Site
  • Richmond Hill, Canada, L4C2N9
    • Altana Pharma/Nycomed Investigational Site
  • Saint John, Canada, E3M3W5
    • Altana Pharma/Nycomed Investigational Site
  • Sherbrooke, Canada, J1H5N4
    • Altana Pharma/Nycomed Investigational Site
  • St Jerome, Canada, J7Z5T3
    • Altana Pharma/Nycomed Investigational Site
  • St Leonard, Canada, H1S3A9
    • Altana Pharma/Nycomed Investigational Site
  • Toronto, Canada, M5G1X5
    • Altana Pharma/Nycomed Investigational Site
  • Winnipeg, Canada, R2K3S8
    • Altana Pharma/Nycomed Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Altana Pharma/Nycomed Investigational Site
    • Calgary, Alberta, Canada, T3C 3P1
      • Altana Pharma/Nycomed Investigational Site
    • Edmonton, Alberta, Canada, T5C 0A3
      • Altana Pharma/Nycomed Investigational Site
    • Spruce Grove, Alberta, Canada, T7X 2Z8
      • Altana Pharma/Nycomed Investigational Site
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 1T4
      • Altana Pharma/Nycomed Investigational Site
    • Penticton, British Columbia, Canada, V2A 5C8
      • Altana Pharma/Nycomed Investigational Site
    • Vancouver, British Columbia, Canada, V5Z 4E1
      • Altana Pharma/Nycomed Investigational Site
  • Nova Scotia
    • Truro, Nova Scotia, Canada, B2N 1L2
      • Altana Pharma/Nycomed Investigational Site
  • Ontario
    • Chatham, Ontario, Canada, N7M 1R2
      • Altana Pharma/Nycomed Investigational Site
    • Hamilton, Ontario, Canada, L8M 1K7
      • Altana Pharma/Nycomed Investigational Site
    • London, Ontario, Canada, N5Y 5K7
      • Altana Pharma/Nycomed Investigational Site
    • Mississauga, Ontario, Canada, L5M 2V8
      • Altana Pharma/Nycomed Investigational Site
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Altana Pharma/Nycomed Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • Altana Pharma/Nycomed Investigational Site
    • Scarborough, Ontario, Canada, M1B 4Z8
      • Altana Pharma/Nycomed Investigational Site
    • Toronto, Ontario, Canada, M5S 2A5
      • Altana Pharma/Nycomed Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H1V 1X5
      • Altana Pharma/Nycomed Investigational Site
    • Montreal, Quebec, Canada, H3S 2W1
      • Altana Pharma/Nycomed Investigational Site
    • Sainte-Foy, Quebec, Canada, G1V4G5
      • Altana Pharma/Nycomed Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 4J6
      • Altana Pharma/Nycomed Investigational Site
    • St. Romuald, Quebec, Canada, G6W 5M6
      • Altana Pharma/Nycomed Investigational Site
    • Ste-Foy, Quebec, Canada, G1W 4R4
      • Altana Pharma/Nycomed Investigational Site
• Germany
  • Berlin, Germany, 10559
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 10717
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 10965
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 10969
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 12165
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 12203
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 13507
    • Altana Pharma/Nycomed Investigational Site
  • Berlin, Germany, 13597
    • Altana Pharma/Nycomed Investigational Site
  • Donaustauf, Germany, 93093
    • Altana Pharma/Nycomed Investigational Site
  • Großhansdorf, Germany, 22927
    • Altana Pharma/Nycomed Investigational Site
  • Halle, Germany, 6108
    • Altana Pharma/Nycomed Investigational Site
  • Hamburg, Germany, 20535
    • Altana Pharma/Nycomed Investigational Site
  • Landsberg/Lech, Germany, 86899
    • Altana Pharma/Nycomed Investigational Site
  • Neuruppin, Germany, 16816
    • Altana Pharma/Nycomed Investigational Site
  • Oschersleben, Germany, 39387
    • Altana Pharma/Nycomed Investigational Site
  • Potsdam, Germany, 14464
    • Altana Pharma/Nycomed Investigational Site
  • Potsdam, Germany, 14467
    • Altana Pharma/Nycomed Investigational Site
  • Regensburg, Germany, 93059
    • Altana Pharma/Nycomed Investigational Site
  • Rüdersdorf, Germany, 15562
    • Altana Pharma/Nycomed Investigational Site
  • Ulm, Germany, 89073
    • Altana Pharma/Nycomed Investigational Site
• India
  • Bangalore, India, 560 002
    • Altana Pharma/Nycomed Investigational Site
  • Bangalore, India, 560 034
    • Altana Pharma/Nycomed Investigational Site
  • Bangalore, Karnataka, India, 560 029
    • Altana Pharma/Nycomed Investigational Site
  • Chennai, India, 600 034
    • Altana Pharma/Nycomed Investigational Site
  • Coimbatore, India, 641 004
    • Altana Pharma/Nycomed Investigational Site
  • Coimbatore, India, 641 014
    • Altana Pharma/Nycomed Investigational Site
  • Coimbatore, Tamilnadu, India, 641 044
    • Altana Pharma/Nycomed Investigational Site
  • Goa, India, 403 002
    • Altana Pharma/Nycomed Investigational Site
  • Hyderabad, India, 12
    • Altana Pharma/Nycomed Investigational Site
  • Indore, South Tukuganj, India, 452001
    • Altana Pharma/Nycomed Investigational Site
  • Mangalore, India, 574 160
    • Altana Pharma/Nycomed Investigational Site
  • Mangalore, India, 575 001
    • Altana Pharma/Nycomed Investigational Site
  • Mumbai, India, 400022
    • Altana Pharma/Nycomed Investigational Site
  • Mumbai, Byculla, India, 400 008
    • Altana Pharma/Nycomed Investigational Site
  • Mumbai, Dadar (E), India, 400 014
    • Altana Pharma/Nycomed Investigational Site
  • Mysore, India, 570004
    • Altana Pharma/Nycomed Investigational Site
  • Nagpur, India, 440 012
    • Altana Pharma/Nycomed Investigational Site
  • Nagpur, India, 440 013
    • Altana Pharma/Nycomed Investigational Site
  • Nagpur, India, 440012
    • Altana Pharma/Nycomed Investigational Site
  • Pune, India, 411 014
    • Altana Pharma/Nycomed Investigational Site
  • Pune, India, 411033
    • Altana Pharma/Nycomed Investigational Site
  • Shastri Nagar, Jaipur, India, 302 016
    • Altana Pharma/Nycomed Investigational Site
• Italy
  • Bergamo, Italy, 24100
    • Altana Pharma/Nycomed Investigational Site
  • Bologna, Italy, 40136
    • Altana Pharma/Nycomed Investigational Site
  • Cassano Murge, Italy, 70020
    • Altana Pharma/Nycomed Investigational Site
  • Firenze, Italy, 50134
    • Altana Pharma/Nycomed Investigational Site
  • Milano, Italy, 20142
    • Altana Pharma/Nycomed Investigational Site
  • Parma, Italy, 43100
    • Altana Pharma/Nycomed Investigational Site
  • Pavia, Italy, 27100
    • Altana Pharma/Nycomed Investigational Site
  • Roma, Italy, 135
    • Altana Pharma/Nycomed Investigational Site
  • Trieste, Italy, 34100
    • Altana Pharma/Nycomed Investigational Site
  • Verona, Italy, 37100
    • Altana Pharma/Nycomed Investigational Site
  • Veruno, Italy, 28010
    • Altana Pharma/Nycomed Investigational Site
• Poland
  • Chrzanów, Poland, 32500
    • Altana Pharma/Nycomed Investigational Site
  • Czestochowa, Poland, 42200
    • Altana Pharma/Nycomed Investigational Site
  • Dzialdowo, Poland, 13-200
    • Altana Pharma/Nycomed Investigational Site
  • Katowice, Poland, 40-752
    • Altana Pharma/Nycomed Investigational Site
  • Kraków, Poland, 31-202
    • Altana Pharma/Nycomed Investigational Site
  • Kraków, Poland, 31202
    • Altana Pharma/Nycomed Investigational Site
  • Lublin, Poland, 20-718
    • Altana Pharma/Nycomed Investigational Site
  • Poznan, Poland, 60-569
    • Altana Pharma/Nycomed Investigational Site
  • Warsawa, Poland, 01-138
    • Altana Pharma/Nycomed Investigational Site
  • Warszawa, Poland, 1140
    • Altana Pharma/Nycomed Investigational Site
  • Wodzislaw Slaski, Poland, 44300
    • Altana Pharma/Nycomed Investigational Site
  • Zgierz, Poland, 95100
    • Altana Pharma/Nycomed Investigational Site
• South Africa
  • Bellville, Cape Town, South Africa, 7530
    • Altana Pharma/Nycomed Investigational Site
  • Berea, Durban, South Africa, 4000
    • Altana Pharma/Nycomed Investigational Site
  • Bloemfontein, South Africa, 9301
    • Altana Pharma/Nycomed Investigational Site
  • C/O Netcare & Garsfontein Roads, South Africa, 44
    • Altana Pharma/Nycomed Investigational Site
  • Cape Town, South Africa, 7764
    • Altana Pharma/Nycomed Investigational Site
  • Cape Town, South Africa, 8001
    • Altana Pharma/Nycomed Investigational Site
  • Cape Town, Tygerberg, South Africa, 7505
    • Altana Pharma/Nycomed Investigational Site
  • Durban, Amanzimtoti, South Africa, 4126
    • Altana Pharma/Nycomed Investigational Site
  • Durbanville / Cape Town, South Africa, 7550
    • Altana Pharma/Nycomed Investigational Site
  • Mowbray, Cape Town, South Africa, 7925
    • Altana Pharma/Nycomed Investigational Site
  • Paarl, Cape Town, South Africa, 7626
    • Altana Pharma/Nycomed Investigational Site
  • Pretoria, South Africa, 181
    • Altana Pharma/Nycomed Investigational Site
  • Somerset West, South Africa, 7130
    • Altana Pharma/Nycomed Investigational Site
• Spain
  • Badajoz, Spain, 6080
    • Altana Pharma/Nycomed Investigational Site
  • Calde (Lugo), Spain, 27210
    • Altana Pharma/Nycomed Investigational Site
  • Cartagena, Spain, 30203
    • Altana Pharma/Nycomed Investigational Site
  • Elda, Spain, 3600
    • Altana Pharma/Nycomed Investigational Site
  • Getafe, Spain, 28905
    • Altana Pharma/Nycomed Investigational Site
  • Guadalajara, Spain, 19002
    • Altana Pharma/Nycomed Investigational Site
  • Madrid, Spain, 28006
    • Altana Pharma/Nycomed Investigational Site
  • Madrid, Spain, 28041
    • Altana Pharma/Nycomed Investigational Site
  • Merida (Badajoz), Spain, 6800
    • Altana Pharma/Nycomed Investigational Site
  • Partida de Bacarot (Alicante), Spain, 3114
    • Altana Pharma/Nycomed Investigational Site
  • Pontevedra, Spain, 36071
    • Altana Pharma/Nycomed Investigational Site
  • Requena, Spain, 46340
    • Altana Pharma/Nycomed Investigational Site
  • Santiago de Compostela, Spain, 15706
    • Altana Pharma/Nycomed Investigational Site
  • Talavera de la Reina (Toledo), Spain, 45600
    • Altana Pharma/Nycomed Investigational Site
  • Tarrasa (Barcelona), Spain, 8221
    • Altana Pharma/Nycomed Investigational Site
  • Toldeo, Spain, 45004
    • Altana Pharma/Nycomed Investigational Site
  • Valencia, Spain, 46015
    • Altana Pharma/Nycomed Investigational Site
  • Valencia, Spain, 46017
    • Altana Pharma/Nycomed Investigational Site
• United States
  • Alabama
    • Bayou La Batre, Alabama, United States, 36509
      • Altana Pharma/Nycomed Investigational Site
    • Birmingham, Alabama, United States, 35249
      • Altana Pharma/Nycomed Investigational Site
    • Birmingham, Alabama, United States, 35294
      • Altana Pharma/Nycomed Investigational Site
    • Huntsville, Alabama, United States, 35801
      • Altana Pharma/Nycomed Investigational Site
  • Arizona
    • Bullhead City, Arizona, United States, 85442
      • Altana Pharma/Nycomed Investigational Site
    • Phoenix, Arizona, United States, 85012
      • Altana Pharma/Nycomed Investigational Site
    • Phoenix, Arizona, United States, 85023
      • Altana Pharma/Nycomed Investigational Site
  • Arkansas
    • Fort Smith, Arkansas, United States, 72917
      • Altana Pharma/Nycomed Investigational Site
    • Little Rock, Arkansas, United States, 72205
      • Altana Pharma/Nycomed Investigational Site
  • California
    • Anaheim, California, United States, 92801
      • Altana Pharma/Nycomed Investigational Site
    • Burbank, California, United States, 91505
      • Altana Pharma/Nycomed Investigational Site
    • Carlsbad, California, United States, 92008
      • Altana Pharma/Nycomed Investigational Site
    • Fresno, California, United States, 93720
      • Altana Pharma/Nycomed Investigational Site
    • Lakewood, California, United States, 90712
      • Altana Pharma/Nycomed Investigational Site
    • Long Beach, California, United States, 90822
      • Altana Pharma/Nycomed Investigational Site
    • Los Alamitos, California, United States, 90720
      • Altana Pharma/Nycomed Investigational Site
    • Los Angeles, California, United States, 90033
      • Altana Pharma/Nycomed Investigational Site
    • Roseville, California, United States, 95678
      • Altana Pharma/Nycomed Investigational Site
    • Sacramento, California, United States, 95831
      • Altana Pharma/Nycomed Investigational Site
    • San Diego, California, United States, 92120
      • Altana Pharma/Nycomed Investigational Site
    • San Diego, California, United States, 92103
      • Altana Pharma/Nycomed Investigational Site
    • Sepulveda, California, United States, 91343
      • Altana Pharma/Nycomed Investigational Site
    • Stockton, California, United States, 95207
      • Altana Pharma/Nycomed Investigational Site
  • Colorado
    • Denver, Colorado, United States, 80206
      • Altana Pharma/Nycomed Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 6708
      • Altana Pharma/Nycomed Investigational Site
  • District of Columbia
    • Washington, District of Columbia, United States, 20017
      • Altana Pharma/Nycomed Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33756
      • Altana Pharma/Nycomed Investigational Site
    • Deland, Florida, United States, 32720
      • Altana Pharma/Nycomed Investigational Site
    • Fort Lauderdale, Florida, United States, 33316
      • Altana Pharma/Nycomed Investigational Site
    • Jacksonville, Florida, United States, 32204
      • Altana Pharma/Nycomed Investigational Site
    • Miami, Florida, United States, 33176
      • Altana Pharma/Nycomed Investigational Site
    • Miami, Florida, United States, 33173
      • Altana Pharma/Nycomed Investigational Site
    • Miami Beach, Florida, United States, 33140
      • Altana Pharma/Nycomed Investigational Site
    • Ocala, Florida, United States, 34471
      • Altana Pharma/Nycomed Investigational Site
    • Ormand Beach, Florida, United States, 32174
      • Altana Pharma/Nycomed Investigational Site
    • Port Orange, Florida, United States, 33127
      • Altana Pharma/Nycomed Investigational Site
    • Tamarac, Florida, United States, 33321
      • Altana Pharma/Nycomed Investigational Site
    • Vero Beach, Florida, United States, 32960
      • Altana Pharma/Nycomed Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Altana Pharma/Nycomed Investigational Site
    • Blue Ridge, Georgia, United States, 30513
      • Altana Pharma/Nycomed Investigational Site
    • Columbus, Georgia, United States, 31901
      • Altana Pharma/Nycomed Investigational Site
    • Decatur, Georgia, United States, 30033
      • Altana Pharma/Nycomed Investigational Site
    • Ft. Gordon, Georgia, United States, 30905
      • Altana Pharma/Nycomed Investigational Site
    • Marietta, Georgia, United States, 30060
      • Altana Pharma/Nycomed Investigational Site
    • Rincon, Georgia, United States, 594
      • Altana Pharma/Nycomed Investigational Site
    • Savannah, Georgia, United States, 31406
      • Altana Pharma/Nycomed Investigational Site
  • Idaho
    • Twin Falls, Idaho, United States, 83301
      • Altana Pharma/Nycomed Investigational Site
  • Illinois
    • Champaign, Illinois, United States, 61820
      • Altana Pharma/Nycomed Investigational Site
    • Chicago, Illinois, United States, 60611
      • Altana Pharma/Nycomed Investigational Site
    • Elk Grove Village, Illinois, United States, 60007
      • Altana Pharma/Nycomed Investigational Site
    • North Chicago, Illinois, United States, 60064
      • Altana Pharma/Nycomed Investigational Site
    • Peoria, Illinois, United States, 61603
      • Altana Pharma/Nycomed Investigational Site
    • River Forest, Illinois, United States, 60305
      • Altana Pharma/Nycomed Investigational Site
  • Indiana
    • Elkhart, Indiana, United States, 46514
      • Altana Pharma/Nycomed Investigational Site
    • Indianapolis, Indiana, United States, 46202
      • Altana Pharma/Nycomed Investigational Site
    • Indianapolis, Indiana, United States, 46254
      • Altana Pharma/Nycomed Investigational Site
    • New Albany, Indiana, United States, 47150
      • Altana Pharma/Nycomed Investigational Site
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • Altana Pharma/Nycomed Investigational Site
    • Fort Dodge, Iowa, United States, 50501
      • Altana Pharma/Nycomed Investigational Site
    • Iowa City, Iowa, United States, 52242
      • Altana Pharma/Nycomed Investigational Site
    • Waterloo, Iowa, United States, 50702
      • Altana Pharma/Nycomed Investigational Site
  • Kansas
    • Olathe, Kansas, United States, 66061
      • Altana Pharma/Nycomed Investigational Site
    • Topeka, Kansas, United States, 66606
      • Altana Pharma/Nycomed Investigational Site
  • Kentucky
    • Campbellsville, Kentucky, United States, 42718
      • Altana Pharma/Nycomed Investigational Site
    • Hazard, Kentucky, United States, 41701
      • Altana Pharma/Nycomed Investigational Site
    • Louisville, Kentucky, United States, 40207
      • Altana Pharma/Nycomed Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Altana Pharma/Nycomed Investigational Site
    • West Monroe, Louisiana, United States, 71291
      • Altana Pharma/Nycomed Investigational Site
  • Maryland
    • Columbia, Maryland, United States, 21044
      • Altana Pharma/Nycomed Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Altana Pharma/Nycomed Investigational Site
  • Michigan
    • Brighton, Michigan, United States, 48114
      • Altana Pharma/Nycomed Investigational Site
    • Interlochen, Michigan, United States, 49643
      • Altana Pharma/Nycomed Investigational Site
    • Livonia, Michigan, United States, 48152
      • Altana Pharma/Nycomed Investigational Site
    • Portage, Michigan, United States, 49002
      • Altana Pharma/Nycomed Investigational Site
    • Saginaw, Michigan, United States, 48602
      • Altana Pharma/Nycomed Investigational Site
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Altana Pharma/Nycomed Investigational Site
    • Edina, Minnesota, United States, 55435
      • Altana Pharma/Nycomed Investigational Site
    • Minneapolis, Minnesota, United States, 55407
      • Altana Pharma/Nycomed Investigational Site
    • Rochester, Minnesota, United States, 55905
      • Altana Pharma/Nycomed Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Altana Pharma/Nycomed Investigational Site
    • Jefferson City, Missouri, United States, 65101
      • Altana Pharma/Nycomed Investigational Site
    • Kansas City, Missouri, United States, 64111
      • Altana Pharma/Nycomed Investigational Site
    • Kansas City (-1453), Missouri, United States, 64106
      • Altana Pharma/Nycomed Investigational Site
    • St. Louis, Missouri, United States, 63122
      • Altana Pharma/Nycomed Investigational Site
    • St. Louis, Missouri, United States, 63141
      • Altana Pharma/Nycomed Investigational Site
    • Sunset, Missouri, United States, 70584
      • Altana Pharma/Nycomed Investigational Site
  • Montana
    • Bozeman, Montana, United States, 59718
      • Altana Pharma/Nycomed Investigational Site
    • Butte, Montana, United States, 59701
      • Altana Pharma/Nycomed Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Altana Pharma/Nycomed Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89123
      • Altana Pharma/Nycomed Investigational Site
    • Las Vegas, Nevada, United States, 89176
      • Altana Pharma/Nycomed Investigational Site
  • New Jersey
    • Absecon, New Jersey, United States, 08201
      • Altana Pharma/Nycomed Investigational Site
    • Hamilton, New Jersey, United States, 08610
      • Altana Pharma/Nycomed Investigational Site
    • South Bound Brook, New Jersey, United States, 08880
      • Altana Pharma/Nycomed Investigational Site
  • New York
    • Camillus, New York, United States, 13031
      • Altana Pharma/Nycomed Investigational Site
    • Corning, New York, United States, 14830
      • Altana Pharma/Nycomed Investigational Site
    • Cortland, New York, United States, 13045
      • Altana Pharma/Nycomed Investigational Site
    • New Hyde Park, New York, United States, 11040
      • Altana Pharma/Nycomed Investigational Site
    • New Hyde Park, New York, United States, 11042
      • Altana Pharma/Nycomed Investigational Site
    • Syracuse, New York, United States, 13210
      • Altana Pharma/Nycomed Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Altana Pharma/Nycomed Investigational Site
    • Huntersville, North Carolina, United States, 28070
      • Altana Pharma/Nycomed Investigational Site
    • Winston Salem, North Carolina, United States, 27103
      • Altana Pharma/Nycomed Investigational Site
  • Ohio
    • Canton, Ohio, United States, 44718
      • Altana Pharma/Nycomed Investigational Site
    • Cincinnati, Ohio, United States, 45231
      • Altana Pharma/Nycomed Investigational Site
    • Columbus, Ohio, United States, 43215
      • Altana Pharma/Nycomed Investigational Site
    • Sylvania, Ohio, United States, 43560
      • Altana Pharma/Nycomed Investigational Site
    • Toledo, Ohio, United States, 43614
      • Altana Pharma/Nycomed Investigational Site
    • Toledo, Ohio, United States, 43608
      • Altana Pharma/Nycomed Investigational Site
    • Toledo, Ohio, United States, 43617
      • Altana Pharma/Nycomed Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Altana Pharma/Nycomed Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • Altana Pharma/Nycomed Investigational Site
    • Portland, Oregon, United States, 97220
      • Altana Pharma/Nycomed Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16506
      • Altana Pharma/Nycomed Investigational Site
    • Hershey, Pennsylvania, United States, 17033
      • Altana Pharma/Nycomed Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • Altana Pharma/Nycomed Investigational Site
    • Philadelphia, Pennsylvania, United States, 19107
      • Altana Pharma/Nycomed Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15221
      • Altana Pharma/Nycomed Investigational Site
    • Stoneboro, Pennsylvania, United States, 16153
      • Altana Pharma/Nycomed Investigational Site
    • Swarthmore, Pennsylvania, United States, 19081
      • Altana Pharma/Nycomed Investigational Site
  • Rhode Island
    • Johnston, Rhode Island, United States, 2919
      • Altana Pharma/Nycomed Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Altana Pharma/Nycomed Investigational Site
    • Greenville, South Carolina, United States, 29605
      • Altana Pharma/Nycomed Investigational Site
    • Greenville, South Carolina, United States, 29615
      • Altana Pharma/Nycomed Investigational Site
    • Greer, South Carolina, United States, 29651
      • Altana Pharma/Nycomed Investigational Site
    • Union, South Carolina, United States, 29379
      • Altana Pharma/Nycomed Investigational Site
    • Williamston, South Carolina, United States, 29697
      • Altana Pharma/Nycomed Investigational Site
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Altana Pharma/Nycomed Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • Altana Pharma/Nycomed Investigational Site
    • Memphis, Tennessee, United States, 38163
      • Altana Pharma/Nycomed Investigational Site
    • Nashville, Tennessee, United States, 37203
      • Altana Pharma/Nycomed Investigational Site
    • New Tazewell, Tennessee, United States, 37825
      • Altana Pharma/Nycomed Investigational Site
  • Texas
    • Boerne, Texas, United States, 78006
      • Altana Pharma/Nycomed Investigational Site
    • Corsicana, Texas, United States, 75110
      • Altana Pharma/Nycomed Investigational Site
    • Fort Worth, Texas, United States, 76109
      • Altana Pharma/Nycomed Investigational Site
    • Houston, Texas, United States, 77005
      • Altana Pharma/Nycomed Investigational Site
    • Houston, Texas, United States, 77024
      • Altana Pharma/Nycomed Investigational Site
    • Hurst, Texas, United States, 76054
      • Altana Pharma/Nycomed Investigational Site
    • McKinney, Texas, United States, 75069
      • Altana Pharma/Nycomed Investigational Site
    • San Antonio, Texas, United States, 78205
      • Altana Pharma/Nycomed Investigational Site
    • San Antonio, Texas, United States, 78229
      • Altana Pharma/Nycomed Investigational Site
    • Seguin, Texas, United States, 78155
      • Altana Pharma/Nycomed Investigational Site
    • Tyler, Texas, United States, 75708
      • Altana Pharma/Nycomed Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Altana Pharma/Nycomed Investigational Site
    • Salt Lake City, Utah, United States, 84124
      • Altana Pharma/Nycomed Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Altana Pharma/Nycomed Investigational Site
  • Washington
    • Seattle, Washington, United States, 98104
      • Altana Pharma/Nycomed Investigational Site
    • Spokane, Washington, United States, 99216
      • Altana Pharma/Nycomed Investigational Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Altana Pharma/Nycomed Investigational Site
  • Wisconsin
    • Glendale, Wisconsin, United States, 53212
      • Altana Pharma/Nycomed Investigational Site
    • Glendale, Wisconsin, United States, 53217
      • Altana Pharma/Nycomed Investigational Site

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; once daily	Drug: Placebo; once daily
Active Comparator: Roflumilast; 500 mcg, once daily, oral administration in the morning	Drug: Roflumilast; 500 mcg, once daily, oral administration in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment
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].	52 weeks treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-bronchodilator FEV1 [L]	Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason		52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)	Mean change from baseline to the last post randomization measurement in natural log-transformed CRP	Change from baseline to last post randomization measurement (52 weeks)
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.	Change from baseline over 52 weeks of treatment

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2006
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: February 27, 2006
• First Submitted That Met QC Criteria: February 27, 2006
• First Posted (Estimate): February 28, 2006

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: October 3, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Chronic obstructive pulmonary disease; Roflumilast
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BY217/M2-125