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

3. oktober 2016 opdateret af: AstraZeneca

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).

Studieoversigt

Status

Afsluttet

Betingelser

Kronisk obstruktiv lungesygdom (KOL)

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1568

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Placebo komparator: Placebo en gang dagligt	Medicin: Placebo en gang dagligt
Aktiv komparator: Roflumilast 500 mcg, én gang dagligt, oral administration om morgenen	Medicin: Roflumilast 500 mcg, én gang dagligt, oral administration om morgenen

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Pre-bronkodilatator Forced Expiratory Volume in First Second (FEV1) Tidsramme: Ændring fra baseline over 52 ugers behandling	Gennemsnitlig ændring fra baseline i behandlingsperioden i præ-bronkodilatator FEV1 [L]	Ændring fra baseline over 52 ugers behandling
KOL-eksacerbationsrate (moderat eller svær) Tidsramme: 52 ugers behandlingsperiode	Gennemsnitlig frekvens af KOL-eksacerbationer, der kræver orale eller parenterale glukokortikosteroider (=moderate KOL-eksacerbationer), eller kræver hospitalsindlæggelse eller fører til død (=alvorlige KOL-eksacerbationer), pr. patient pr. år. En KOL-eksacerbation er en hændelse i det naturlige sygdomsforløb karakteriseret ved en ændring i patientens grundlæggende dyspnø, hoste og/eller opspyt ud over den daglige variabilitet, der er tilstrækkelig til at berettige en ændring i behandlingen [American Thoracic Society (ATS)/ European Respiratory Society (ERS) 2005].	52 ugers behandlingsperiode

Sekundære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Post-bronkodilatator FEV1 [L] Tidsramme: Ændring fra baseline over 52 ugers behandling	Gennemsnitlig ændring fra baseline i behandlingsperioden i post-bronkodilatator FEV1 [L]	Ændring fra baseline over 52 ugers behandling
Tid til dødelighed af enhver grund Tidsramme: 52 ugers behandlingsperiode		52 ugers behandlingsperiode
Naturligt log-transformeret C-reaktivt protein (CRP) Tidsramme: Ændring fra baseline til sidste måling efter randomisering (52 uger)	Gennemsnitlig ændring fra baseline til den sidste post-randomiseringsmåling i naturlig log-transformeret CRP	Ændring fra baseline til sidste måling efter randomisering (52 uger)
Mean Transition Dyspnea Index (TDI) Focal Score under behandlingsperioden Tidsramme: Ændring fra baseline over 52 ugers behandling	TDI er et anerkendt spørgeskema til måling af dyspnø i en udepatient KOL-population. Ved baseline blev 3 komponenter af dyspnø, hver bedømt med 4 spørgsmål, stillet: - Funktionsnedsættelse - Opgavens størrelse - Indsatsens størrelse Ved hvert af post-randomiseringsbesøgene blev spørgsmål fra TDI stillet relateret til 3 komponenter: Ændring i - Funktionsnedsættelse - Opgavens størrelse - Indsatsens størrelse Hvert spørgsmål i TDI'en er graderet fra -3 (større forringelse) til +3 (større forbedring). Dette resulterer i en TDI Focal Score fra -9 til +9.	Ændring fra baseline over 52 ugers behandling

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AstraZeneca

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2006

Primær færdiggørelse (Faktiske)

1. april 2008

Studieafslutning (Faktiske)

1. august 2008

Datoer for studieregistrering

Først indsendt

27. februar 2006

Først indsendt, der opfyldte QC-kriterier

27. februar 2006

Først opslået (Skøn)

28. februar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. november 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. oktober 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

BY217/M2-125

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Placebo

Galderma R&D

Afsluttet

Effekt af CD07805/47 Gel i Rosacea Flushing

Rosacea

Tyskland
SamA Pharmaceutical Co., Ltd

Ukendt

Kliniske forsøg for at vurdere effektiviteten og sikkerheden af HLIM

Akut bronkitis | Akut øvre luftvejsinfektion

Korea, Republikken
National Institute on Drug Abuse (NIDA)

Afsluttet

Virkninger af cannabisadministrationsveje på menneskelig ydeevne og farmakokinetik

Brug af cannabis

Forenede Stater
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Afsluttet

Vurdering af sikkerhed, tolerabilitet og farmakodynamik efter administration af én dosis AZD8601 til mandlige patienter med type II diabetes mellitus (T2DM)

Mandlige forsøgspersoner med type II-diabetes (T2DM)

Tyskland
Heptares Therapeutics Limited

Afsluttet

Farmakokinetik af oral kapsel hos raske japanske vs. kaukasiske forsøgspersoner (HTL0018318)

Farmakokinetik | Sikkerhedsproblemer

Det Forenede Kongerige
Texas A&M University
Nutrabolt

Afsluttet

Glycemic Response of a Commercial Food Bar (NB16)

Glucose and Insulin Response
Regado Biosciences, Inc.

Afsluttet

Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD (SC101)

Sund frivillig

Forenede Stater
Longeveron Inc.

Afsluttet

Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome (ELPIS)

Hypoplastisk venstre hjerte syndrom

Forenede Stater
Italfarmaco

Afsluttet

Klinisk undersøgelse for at evaluere effektiviteten og sikkerheden af Givinostat hos ambulante patienter med Becker muskeldystrofi

Beckers muskeldystrofi

Holland, Italien
West Penn Allegheny Health System

Afsluttet

Sunovion vækstundersøgelse Pædiatriske forsøgspersoner med mild astma og allergisk rhinitis

Astma | Allergisk rhinitis

Forenede Stater

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

Studieoversigt

Status

Betingelser

Intervention / Behandling

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Køn, der er berettiget til at studere

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Publikationer og nyttige links

Generelle publikationer

Datoer for undersøgelser

Studer store datoer

Studiestart

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Skøn)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Kliniske forsøg med Placebo

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Guinea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer