Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)

March 16, 2017 updated by: AstraZeneca

Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2354

Phase

Phase 4

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

Argentina
- - Buenos Aires, Argentina, B1842DID
    - Forest Investigative Site 403
  - Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO
    - Forest Investigative Site 411
  - Ciudad Autonoma de Buenos Aires, Argentina, C1122AAK
    - Forest Investigative Site 414
  - Ciudad Autonoma de Buenos Aires, Argentina, C1426ABP
    - Forest Investigative Site 419
  - Ciudad Autonoma de Buenos Aires, Argentina, C1428DDE
    - Forest Investigative Site 416
  - Derqui Pilar - Buenos Aires, Argentina, B1629ODT
    - Forest Investigative Site 415
  - Florencio Varela, Argentina, 1888
    - Forest Investigative Site 410
  - La Plata, Argentina, 1900
    - Forest Investigative Site 417
  - Mendoza, Argentina, 5500
    - Forest Investigative Site 420
  - Mendoza, Argentina, M5500CCG
    - Forest Investigative Site 404
  - San Miguel de Tucuman, Argentina, T4000IFL
    - Forest Investigative Site 401
  - Santa Fe, Argentina, 3000
    - Forest Investigative Site 408
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DES
    - Forest Investigative Site 418
  - Florida, Buenos Aires, Argentina, B1602DOH
    - Forest Investigative Site 402
  - La Plata, Buenos Aires, Argentina, 1900
    - Forest Investigative Site 405
  - Mar del Plata, Buenos Aires, Argentina, CP 7600
    - Forest Investigative Site 413
- Entre Rios
  - Parana, Entre Rios, Argentina, E3100BHK
    - Forest Investigative Site 407
- Provincia de Buenos Aires
  - Lanús Este, Provincia de Buenos Aires, Argentina, B1824 KAJ
    - Forest Investigative Site 406
- Santa Fe
  - Rosario, Santa Fe, Argentina, S2000DBS
    - Forest Investigative Site 412
  - Rosario, Santa Fe, Argentina, S2000KZD
    - Forest Investigative Site 409
Canada
- Alberta
  - Calgary, Alberta, Canada, T2K5R7
    - Forest Investigative Site 235
- British Columbia
  - North Vancouver, British Columbia, Canada, V7M 2H9
    - Forest Investigative Site 162
- Ontario
  - Burlington, Ontario, Canada, L7N 3V2
    - Forest Investigative Site 302
- Quebec
  - Montreal, Quebec, Canada, H2R 1V6
    - Forest Investigative Site 185
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N0W8
    - Forest Investigative Site 127
Chile
- - Talcahuano, Chile, 4270918
    - Forest Investigative Site 421
Colombia
- - Bogota, Colombia, 111111
    - Forest Investigative Site 442
  - Bogota, Colombia, 111711
    - Forest Investigative Site 443
Italy
- - Chieti, Italy, 66013
    - Forest Investigative Site 461
  - Roma, Italy, 00168
    - Forest Investigative Site 464
Malaysia
- - Batu Caves, Malaysia, 68100
    - Forest Investigative Site 505
  - Kuala Lumpur, Malaysia, 50588
    - Forest Investigative Site 501
  - Kuala Lumpur, Malaysia, 59100
    - Forest Investigative Site 504
  - Kuantan, Malaysia, 25100
    - Forest Investigative Site 502
Mexico
- - Guadalajara, Mexico, 44100
    - Forest Investigative Site 524
  - Monterrey, Mexico, 64060
    - Forest Investigative Site 521
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Forest Investigative Site 522
- Yucatan
  - Merida, Yucatan, Mexico, 97070
    - Forest Investigative Site 526
Peru
- - Bellavista, Peru, Callao 2
    - Forest Investigative Site 543
  - Lima, Peru, Lima 11
    - Forest Investigative Site 550
  - Lima, Peru, Lima 13
    - Forest Investigative Site 551
  - Lima, Peru, Lima 18
    - Forest Investigative Site 545
  - Lima, Peru, Lima 27
    - Forest Investigative Site 546
  - Lima, Peru, Lima 31
    - Forest Investigative Site 549
  - Lima, Peru, Lima 33
    - Forest Investigative Site 544
  - Pueblo Libre, Peru, Lima 21
    - Forest Investigative Site 541
Philippines
- - Cavite, Philippines, 4114
    - Forest Investigative Site 569
  - Iloilo City, Philippines, 5000
    - Forest Investigative Site 567
  - Iloilo City, Philippines, 5000
    - Forest Investigative Site 568
  - Manila, Philippines, 1000
    - Forest Investigative Site 565
  - Pasig City, Philippines, 1600
    - Forest Investigative Site 563
  - Quezon City, Philippines, 1100
    - Forest Investigative Site 562
  - Quezon City, Philippines, 1100
    - Forest Investigative Site 564
  - Quezon City, Philippines, 1109
    - Forest Investigative Site 566
  - Quezon City, Philippines, 1118
    - Forest Investigative Site 561
Romania
- - Brasov, Romania, 500112
    - Forest Investigative Site 585
  - Bucharest, Romania, 10457
    - Forest Investigative Site 586
  - Bucharest, Romania, 30303
    - Forest Investigative Site 587
  - Bucharest, Romania, 31298
    - Forest Investigative Site 588
  - Bucharest, Romania, 50159
    - Forest Investigative Site 584
  - Bucharest, Romania, 50554
    - Forest Investigative Site 582
  - Iasi, Romania, 700115
    - Forest Investigative Site 581
  - Iasi, Romania, 700115
    - Forest Investigative Site 583
Russian Federation
- - Barnaul, Russian Federation, 656045
    - Forest Investigative Site 608
  - Kazan, Russian Federation, 420015
    - Forest Investigative Site 602
  - Kemerovo, Russian Federation, 650000
    - Forest Investigative Site 618
  - Krasnodar, Russian Federation, 350012
    - Forest Investigative Site 609
  - Krasnoyarsk, Russian Federation, 660022
    - Forest Investigative Site 614
  - Moscow, Russian Federation, 125367
    - Forest Investigative Site 617
  - Novosibirsk, Russian Federation, 630099
    - Forest Investigative Site 605
  - St Petersburg, Russian Federation, 197706
    - Forest Investigative Site 600
  - St. Petersburg, Russian Federation, 193231
    - Forest Investigative Site 612
  - St. Petersburg, Russian Federation, 194044
    - Forest Investigative Site 619
  - St. Petersburg, Russian Federation, 194358
    - Forest Investigative Site 604
  - St. Petersburg, Russian Federation, 196084
    - Forest Investigative Site 611
  - St. Petersburg, Russian Federation, 196247
    - Forest Investigative Site 610
  - St. Petersburg, Russian Federation, 197110
    - Forest Investigative Site 601
  - St.Petersburg, Russian Federation, 191025
    - Forest Investigative Site 606
  - Tomsk, Russian Federation, 634063
    - Forest Investigative Site 607
  - Yaroslavl, Russian Federation, 150003
    - Forest Investigative Site 620
Serbia
- - Belgrade, Serbia, 11000
    - Forest Investigative Site 622
  - Belgrade, Serbia, 11000
    - Forest Investigative Site 623
  - Belgrade, Serbia, 11000
    - Forest Investigative Site 624
  - Beograd, Serbia, 11000
    - Forest Investigative Site 625
  - Kragujevac, Serbia, 34000
    - Forest Investigative Site 628
  - Sremska Kamenica, Serbia, 21204
    - Forest Investigative Site 627
- Nišava District
  - Knez Selo, Nišava District, Serbia, 18204
    - Forest Investigative Site 629
Spain
- - Cadiz, Spain, 11009
    - Forest Investigative Site 641
  - Loja, Spain, 18300
    - Forest Investigative Site 647
  - Salt, Spain, 17190
    - Forest Investigative Site 644
Taiwan
- - Kaohsiung Hsien, Taiwan, 833
    - Forest Investigative Site 723
  - Puzih City, Taiwan, 61363
    - Forest Investigative Site 724
  - Taipei, Taiwan, 100
    - Forest Investigative Site 725
  - Taipei, Taiwan, 11490
    - Forest Investigative Site 722
Thailand
- - Bangkok, Thailand, 10400
    - Forest Investigative Site 664
  - Bangkok, Thailand, 11000
    - Forest Investigative Site 663
  - Muang, Thailand, 40002
    - Forest Investigative Site 661
- Songkhla
  - Hat Yai, Songkhla, Thailand, 90110
    - Forest Investigative Site 662
Ukraine
- - Cherkasy, Ukraine, 18009
    - Forest Investigative Site 699
  - Dnipropetrovsk, Ukraine, 49074
    - Forest Investigative Site 691
  - Donetsk, Ukraine, 83003
    - Forest Investigative Site 692
  - Donetsk, Ukraine, 83099
    - Forest Investigative Site 689
  - Ivano-Frankivsk, Ukraine, 76018
    - Forest Investigative Site 690
  - Kharkiv, Ukraine, 61035
    - Forest Investigative Site 697
  - Kharkiv, Ukraine, 61039
    - Forest Investigative Site 693
  - Kharkiv, Ukraine, 61124
    - Forest Investigative Site 682
  - Kremenchuk, Ukraine
    - Forest Investigative Site 709
  - Kyiv, Ukraine, 3049
    - Forest Investigative Site 698
  - Kyiv, Ukraine, 3680
    - Forest Investigative Site 683
  - Kyiv, Ukraine, 3680
    - Forest Investigative Site 684
  - Kyiv, Ukraine, 3680
    - Forest Investigative Site 687
  - Kyiv, Ukraine, 4050
    - Forest Investigative Site 685
  - Lviv, Ukraine, 79013
    - Forest Investigative Site 681
  - Mykolayiv, Ukraine, 54003
    - Forest Investigative Site 708
  - Poltava, Ukraine, 36038
    - Forest Investigative Site 706
  - Sumy, Ukraine, 40000
    - Forest Investigative Site 695
  - Vinnitsa, Ukraine, 21001
    - Forest Investigative Site 707
  - Zaporizhzhia, Ukraine, 69600
    - Forest Investigative Site 688
  - Zaporizhzhya, Ukraine, 69035
    - Forest Investigative Site 696
  - Zaporizhzhya, Ukraine, 69106
    - Forest Investigative Site 694
  - Zaporizhzhya, Ukraine, 69118
    - Forest Investigative Site 705
United States
- Alabama
  - Anniston, Alabama, United States, 36207
    - Forest Investigative Site 081
  - Athens, Alabama, United States, 35611
    - Forest Investigative Site 065
  - Florence, Alabama, United States, 35630
    - Forest Investigative Site 131
  - Mobile, Alabama, United States, 36608
    - Forest Investigative Site 073
- Arizona
  - Mesa, Arizona, United States, 85206
    - Forest Investigative Site 272
  - Peoria, Arizona, United States, 85381
    - Forest Investigative Site 091
  - Phoenix, Arizona, United States, 85018
    - Forest Investigative Site 034
  - Phoenix, Arizona, United States, 85020
    - Forest Investigative Site 188
  - Phoenix, Arizona, United States, 85028
    - Forest Investigative Site 211
  - Phoenix, Arizona, United States, 85050
    - Forest Investigative Site 247
- Arkansas
  - Fort Smith, Arkansas, United States, 72901
    - Forest Investigative Site 208
  - Little Rock, Arkansas, United States, 72205
    - Forest Investigative Site 101
- California
  - Bellflower, California, United States, 90706
    - Forest Investigative Site 074
  - Fresno, California, United States, 93721
    - Forest Investigative Site 060
  - Fresno, California, United States, 93726
    - Forest Investigative Site 329
  - Fullerton, California, United States, 92835
    - Forest Investigative Site 245
  - Garden Grove, California, United States, 92844
    - Forest Investigative Site 310
  - Lakewood, California, United States, 90712
    - Forest Investigative Site 297
  - Long Beach, California, United States, 90822
    - Forest Investigative Site 116
  - Los Angeles, California, United States, 90048
    - Forest Investigative Site 085
  - Los Angeles, California, United States, 90073
    - Forest Investigative Site 241
  - Northridge, California, United States, 91325
    - Forest Investigative Site 299
  - Palo Alto, California, United States, 94555
    - Forest Investigative Site 213
  - Pismo Beach, California, United States, 93449
    - Forest Investigative Site 268
  - Riverside, California, United States, 92506
    - Forest Investigative Site 025
  - Roseville, California, United States, 95661
    - Forest Investigative Site 143
  - Sacramento, California, United States, 95817
    - Forest Investigative Site 104
  - San Diego, California, United States, 92117
    - Forest Investigative Site 352
  - San Diego, California, United States, 92120
    - Forest Investigative Site 038
  - San Jose, California, United States, 95124
    - Forest Investigative Site 326
  - Torrance, California, United States, 90502
    - Forest Investigative Site 209
- Connecticut
  - Stamford, Connecticut, United States, 06902
    - Forest Investigative Site 331
  - Waterbury, Connecticut, United States, 06708
    - Forest Investigative Site 017
- Delaware
  - Newark, Delaware, United States, 19713
    - Forest Investigative Site 124
- Florida
  - Brandon, Florida, United States, 33511
    - Forest Investigative Site 196
  - Brandon, Florida, United States, 33511
    - Forest Investigative Site 224
  - Brandon, Florida, United States, 33511
    - Forest Investigative Site 358
  - Chiefland, Florida, United States, 32626
    - Forest Investigative Site 166
  - Clearwater, Florida, United States, 33756
    - Forest Investigative Site 111
  - Clearwater, Florida, United States, 33765
    - Forest Investigative Site 123
  - Coral Gables, Florida, United States, 33134
    - Forest Investigative Site 291
  - DeFuniak Springs, Florida, United States, 32435
    - Forest Investigative Site 239
  - Fort Lauderdale, Florida, United States, 33316
    - Forest Investigative Site 001
  - Fort Walton Beach, Florida, United States, 32547
    - Forest Investigative Site 165
  - Gainesville, Florida, United States, 32608
    - Forest Investigative Site 102
  - Hollywood, Florida, United States, 33024
    - Forest Investigative Site 003
  - Jacksonville, Florida, United States, 32216
    - Forest Investigative Site 023
  - Kissimmee, Florida, United States, 34741
    - Forest Investigative Site 077
  - Kissimmee, Florida, United States, 34741
    - Forest Investigative Site 330
  - Miami, Florida, United States, 33015
    - Forest Investigative Site 027
  - Miami, Florida, United States, 33136
    - Forest Investigative Site 229
  - Miami, Florida, United States, 33175
    - Forest Investigative Site 115
  - Miami, Florida, United States, 33186
    - Forest Investigative Site 339
  - Naples, Florida, United States, 34119
    - Forest Investigative Site 092
  - Orlando, Florida, United States, 32822
    - Forest Investigative Site 004
  - Ormond Beach, Florida, United States, 32174
    - Forest Investigative Site 187
  - Pensacola, Florida, United States, 32504
    - Forest Investigative Site 069
  - Ponte Vedra, Florida, United States, 32081
    - Forest Investigative Site 161
  - Port Orange, Florida, United States, 32127
    - Forest Investigative Site 087
  - Saint Petersburg, Florida, United States, 33744
    - Forest Investigative Site 357
  - St. Cloud, Florida, United States, 34769
    - Forest Investigative Site 109
  - St. Petersburg, Florida, United States, 33704
    - Forest Investigative Site 121
  - Tamarac, Florida, United States, 33312
    - Forest Investigative Site 002
  - Tampa, Florida, United States, 33607
    - Forest Investigative Site 287
  - Tampa, Florida, United States, 33613
    - Forest Investigative Site 052
  - Winter Park, Florida, United States, 32789
    - Forest Investigative Site 011
  - Winter Park, Florida, United States, 32792
    - Forest Investigative Site 348
- Georgia
  - Canton, Georgia, United States, 30114
    - Forest Investigative Site 103
  - Dawsonville, Georgia, United States, 30534
    - Forest Investigative Site 292
  - Duluth, Georgia, United States, 30096
    - Forest Investigative Site 042
  - Gainesville, Georgia, United States, 30501
    - Forest Investigative Site 140
  - Lawrenceville, Georgia, United States, 30046
    - Forest Investigative Site 030
  - Woodstock, Georgia, United States, 30189
    - Forest Investigative Site 321
- Idaho
  - Coeur d' Alene, Idaho, United States, 83814
    - Forest Investigative Site 008
  - Eagle, Idaho, United States, 83616
    - Forest Investigative Site 119
- Illinois
  - Bolingbrook, Illinois, United States, 60490
    - Forest Investigative Site 201
  - Downers Grove, Illinois, United States, 60515
    - Forest Investigative Site 206
  - Elk Grove Village, Illinois, United States, 60007
    - Forest Investigative Site 136
  - Oak Lawn, Illinois, United States, 60453
    - Forest Investigative Site 139
  - Peoria, Illinois, United States, 61637
    - Forest Investigative Site 227
  - Springfield, Illinois, United States, 62703
    - Forest Investigative Site 334
- Indiana
  - Elwood, Indiana, United States, 46036
    - Forest Investigative Site 263
  - Lafayette, Indiana, United States, 47904
    - Forest Investigative Site 342
  - Michigan City, Indiana, United States, 46360
    - Forest Investigative Site 293
  - Muncie, Indiana, United States, 47303
    - Forest Investigative Site 264
- Iowa
  - Council Bluffs, Iowa, United States, 51503
    - Forest Investigative Site 135
  - Iowa City, Iowa, United States, 52242
    - Forest Investigative Site 256
- Kansas
  - Olathe, Kansas, United States, 66061
    - Forest Investigative Site 214
  - Topeka, Kansas, United States, 66606
    - Forest Investigative Site 316
  - Wichita, Kansas, United States, 67205
    - Forest Investigative Site 301
- Kentucky
  - Bowling Green, Kentucky, United States, 42101
    - Forest Investigative Site 051
  - Crescent Springs, Kentucky, United States, 41017
    - Forest Investigative Site 075
  - Hazard, Kentucky, United States, 41701
    - Forest Investigative Site 351
  - Lexington, Kentucky, United States, 40504
    - Forest Investigative Site 068
  - Louisville, Kentucky, United States, 40215
    - Forest Investigative Site 088
  - Owensboro, Kentucky, United States, 42303
    - Forest Investigative Site 053
- Louisiana
  - Lafayette, Louisiana, United States, 70503
    - Forest Investigative Site 273
  - Opelousas, Louisiana, United States, 70570
    - Forest Investigative Site 070
  - Sunset, Louisiana, United States, 70584
    - Forest Investigative Site 097
- Maine
  - Lewiston, Maine, United States, 04240
    - Forest Investigative Site 128
- Maryland
  - Baltimore, Maryland, United States, 21224
    - Forest Investigative Site 248
  - Columbia, Maryland, United States, 21044
    - Forest Investigative Site 020
  - Towson, Maryland, United States, 21204
    - Forest Investigative Site 072
- Massachusetts
  - Fall River, Massachusetts, United States, 02720
    - Forest Investigative Site 106
  - North Dartmouth, Massachusetts, United States, 02747
    - Forest Investigative Site 044
  - Pittsfield, Massachusetts, United States, 01201
    - Forest Investigative Site 350
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Forest Investigative Site 157
  - Detroit, Michigan, United States, 48202
    - Forest Investigative Site 341
  - Kalamazoo, Michigan, United States, 49009
    - Forest Investigative Site 328
  - Livonia, Michigan, United States, 48152
    - Forest Investigative Site 063
  - Saint Joseph, Michigan, United States, 49085
    - Forest Investigative Site 322
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Forest Investigative Site 303
  - Fridley, Minnesota, United States, 55432
    - Forest Investigative Site 056
  - Rochester, Minnesota, United States, 55905
    - Forest Investigative Site 082
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Forest Investigative Site 033
  - Springfield, Missouri, United States, 65803
    - Forest Investigative Site 117
  - St. Charles, Missouri, United States, 63301
    - Forest Investigative Site 098
  - St. Louis, Missouri, United States, 63141
    - Forest Investigative Site 186
  - St. Louis, Missouri, United States, 63143
    - Forest Investigative Site 288
- Montana
  - Butte, Montana, United States, 59701
    - Forest Investigative Site 333
  - Missoula, Montana, United States, 59808
    - Forest Investigative Site 029
- Nebraska
  - Bellevue, Nebraska, United States, 68123
    - Forest Investigative Site 197
  - Fremont, Nebraska, United States, 68025
    - Forest Investigative Site 267
  - Fremont, Nebraska, United States, 68028
    - Forest Investigative Site 337
  - Lincoln, Nebraska, United States, 68506
    - Forest Investigative Site 315
  - Lincoln, Nebraska, United States, 68510
    - Forest Investigative Site 108
  - Omaha, Nebraska, United States, 68114
    - Forest Investigative Site 345
- Nevada
  - Henderson, Nevada, United States, 89014
    - Forest Investigative Site 079
  - Henderson, Nevada, United States, 89052
    - Forest Investigative Site 270
- New Jersey
  - Cherry Hill, New Jersey, United States, 08003
    - Forest Investigative Site 067
  - Clifton, New Jersey, United States, 07012
    - Forest Investigative Site 327
  - Hackensack, New Jersey, United States, 07601
    - Forest Investigative Site 144
  - Summit, New Jersey, United States, 07901
    - Forest Investigative Site 317
- New York
  - Brooklyn, New York, United States, 11229
    - Forest Investigative Site 226
  - Great Neck, New York, United States, 11021
    - Forest Investigative Site 199
  - New York, New York, United States, 10029
    - Forest Investigative Site 071
  - Rochester, New York, United States, 14618
    - Forest Investigative Site 013
  - Syracuse, New York, United States, 13210
    - Forest Investigative Site 066
  - West Seneca, New York, United States, 14224
    - Forest Investigative Site 158
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Forest Investigative Site 313
  - Burlington, North Carolina, United States, 27215
    - Forest Investigative Site 193
  - Charlotte, North Carolina, United States, 28207
    - Forest Investigative Site 142
  - Charlotte, North Carolina, United States, 28277
    - Forest Investigative Site 259
  - Elizabeth City, North Carolina, United States, 27909
    - Forest Investigative Site 019
  - Shelby, North Carolina, United States, 28150
    - Forest Investigative Site 318
  - Shelby, North Carolina, United States, 28152
    - Forest Investigative Site 078
  - Wilmington, North Carolina, United States, 28451
    - Forest Investigative Site 176
  - Winston Salem, North Carolina, United States, 27103
    - Forest Investigative Site 314
  - Winston-Salem, North Carolina, United States, 27103
    - Forest Investigative Site 282
- Ohio
  - Canton, Ohio, United States, 44718
    - Forest Investigative Site 164
  - Cincinatti, Ohio, United States, 45231
    - Forest Investigative Site 061
  - Cincinnati, Ohio, United States, 45219
    - Forest Investigative Site 149
  - Cincinnati, Ohio, United States, 45242
    - Forest Investigative Site 040
  - Cincinnati, Ohio, United States, 45267
    - Forest Investigative Site 280
  - Columbus, Ohio, United States, 43213
    - Forest Investigative Site 009
  - Dayton, Ohio, United States, 45439
    - Forest Investigative Site 353
  - Marion, Ohio, United States, 43302
    - Forest Investigative Site 059
  - Marion, Ohio, United States, 43302
    - Forest Investigative Site 154
  - Toledo, Ohio, United States, 43606
    - Forest Investigative Site 346
  - Zanesville, Ohio, United States, 43701
    - Forest Investigative Site 105
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73103
    - Forest Investigative Site 167
  - Oklahoma City, Oklahoma, United States, 73103
    - Forest Investigative Site 281
  - Tulsa, Oklahoma, United States, 74135
    - Forest Investigative Site 236
- Oregon
  - Medford, Oregon, United States, 97501
    - Forest Investigative Site 285
  - Portland, Oregon, United States, 97220
    - Forest Investigative Site 289
  - Portland, Oregon, United States, 97227
    - Forest Investigative Site 218
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16601
    - Forest Investigative Site 086
  - Beaver, Pennsylvania, United States, 15009
    - Forest Investigative Site 340
  - Downingtown, Pennsylvania, United States, 19335
    - Forest Investigative Site 120
  - Erie, Pennsylvania, United States, 16506
    - Forest Investigative Site 062
  - Norristown, Pennsylvania, United States, 19401
    - Forest Investigative Site 277
  - Philadelphia, Pennsylvania, United States, 19107
    - Forest Investigative Site 230
  - Philadelphia, Pennsylvania, United States, 19140
    - Forest Investigative Site 205
  - Pittsburgh, Pennsylvania, United States, 15221
    - Forest Investigative Site 336
  - Pittsburgh, Pennsylvania, United States, 15240
    - Forest Investigative Site 364
  - Pittsburgh, Pennsylvania, United States, 15243
    - Forest Investigative Site 344
  - Tipton, Pennsylvania, United States, 16684
    - Forest Investigative Site 010
  - Uniontown, Pennsylvania, United States, 15401
    - Forest Investigative Site 064
- Rhode Island
  - Johnston, Rhode Island, United States, 02919
    - Forest Investigative Site 228
  - Lincoln, Rhode Island, United States, 02865
    - Forest Investigative Site 283
  - Providence, Rhode Island, United States, 02903
    - Forest Investigative Site 365
- South Carolina
  - Charleston, South Carolina, United States, 29406
    - Forest Investigative Site 305
  - Easley, South Carolina, United States, 29640
    - Forest Investigative Site 093
  - Fort Mill, South Carolina, United States, 29707
    - Forest Investigative Site 257
  - Gaffney, South Carolina, United States, 29340
    - Forest Investigative Site 233
  - Greenville, South Carolina, United States, 29615
    - Forest Investigative Site 110
  - Pelzer, South Carolina, United States, 29669
    - Forest Investigative Site 300
  - Rock Hill, South Carolina, United States, 29732
    - Forest Investigative Site 204
  - Spartanburg, South Carolina, United States, 29303
    - Forest Investigative Site 021
  - Union, South Carolina, United States, 29379
    - Forest Investigative Site 012
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Forest Investigative Site 058
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Forest Investigative Site 223
  - Fayetteville, Tennessee, United States, 37334
    - Forest Investigative Site 050
  - Shelbyville, Tennessee, United States, 37160
    - Forest Investigative Site 253
- Texas
  - Arlington, Texas, United States, 76012
    - Forest Investigative Site 024
  - Boerne, Texas, United States, 78006
    - Forest Investigative Site 177
  - Corsicana, Texas, United States, 75110
    - Forest Investigative Site 090
  - Dallas, Texas, United States, 75246
    - Forest Investigative Site 172
  - Houston, Texas, United States, 77030
    - Forest Investigative Site 237
  - Houston, Texas, United States, 77030
    - Forest Investigative Site 271
  - Houston, Texas, United States, 77030
    - Forest Investigative Site 370
  - Houston, Texas, United States, 77034
    - Forest Investigative Site 195
  - Houston, Texas, United States, 77079
    - Forest Investigative Site 312
  - Huntsville, Texas, United States, 77340
    - Forest Investigative Site 332
  - Longview, Texas, United States, 75605
    - Forest Investigative Site 232
  - Tyler, Texas, United States, 75708
    - Forest Investigative Site 049
- Vermont
  - Colchester, Vermont, United States, 05446
    - Forest Investigative Site 181
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Forest Investigative Site 125
  - Richmond, Virginia, United States, 23225
    - Forest Investigative Site 202
  - Richmond, Virginia, United States, 23229
    - Forest Investigative Site 231
  - Richmond, Virginia, United States, 23233
    - Forest Investigative Site 045
- Washington
  - Spokane, Washington, United States, 99202
    - Forest Investigative Site 184
  - Spokane, Washington, United States, 99204
    - Forest Investigative Site 174
  - Tacoma, Washington, United States, 98405
    - Forest Investigative Site 217
- West Virginia
  - Charleston, West Virginia, United States, 25304
    - Forest Investigative Site 335
  - Morgantown, West Virginia, United States, 26505
    - Forest Investigative Site 319
- Wisconsin
  - West Allis, Wisconsin, United States, 53227
    - Forest Investigative Site 146

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

1. Male or female patients at least 40 years of age
2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1)
4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria:

1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
2. Known alpha-1-antitrypsin deficiency
3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
4. Body mass index (BMI) ≥ 45 kg/m2
5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer

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: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2 Placebo	Drug: Placebo Dose-matched placebo, oral administration, once per day.
Experimental: 1 Roflumilast	Drug: Roflumilast Roflumilast 500 µg, oral administration, once per day Other Names: Daliresp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year. Time Frame: Baseline to Week 52	Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.	Baseline to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations) Time Frame: Week 0 (Visit 2) to Week 52	Rate of moderate or severe COPD exacerbations, defined as requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.	Week 0 (Visit 2) to Week 52
Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics Time Frame: Week 0 (Visit 2) to Week 52	Rate of moderate or severe COPD exacerbations treated with antibiotics during the double-blind treatment period.	Week 0 (Visit 2) to Week 52
Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1) Time Frame: Week 0 (Visit 2) to Week 52	Mean change from randomization (Visit 2) over 52 weeks of treatment in predose forced expiratory volume in 1 second (FEV1)	Week 0 (Visit 2) to Week 52

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

Helpful Links

RESPOND Protocol_Redacted

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 (Actual)

September 30, 2011

Primary Completion (Actual)

November 30, 2015

Study Completion (Actual)

January 31, 2016

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 30, 2011

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

March 16, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

ROF-MD-07

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Lung Diseases

Clinical Trials on Roflumilast

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