Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
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)
1 other identifier
interventional
2,354
17 countries
338
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2011
Longer than P75 for phase_4
338 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2011
CompletedFirst Posted
Study publicly available on registry
September 30, 2011
CompletedStudy Start
First participant enrolled
September 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2016
CompletedResults Posted
Study results publicly available
January 25, 2017
CompletedApril 13, 2017
March 1, 2017
4.2 years
September 28, 2011
November 30, 2016
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.
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 Outcomes (3)
Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)
Week 0 (Visit 2) to Week 52
Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics
Week 0 (Visit 2) to Week 52
Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)
Week 0 (Visit 2) to Week 52
Study Arms (2)
1
EXPERIMENTALRoflumilast
2
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- \. Male or female patients at least 40 years of age
- \. 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)
- \. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
- \. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
- \. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
- \. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
- \. 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
You may not qualify if:
- \. 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)
- \. Known alpha-1-antitrypsin deficiency
- \. Body mass index (BMI) ≥ 45 kg/m2
- \. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (338)
Forest Investigative Site 081
Anniston, Alabama, 36207, United States
Forest Investigative Site 065
Athens, Alabama, 35611, United States
Forest Investigative Site 131
Florence, Alabama, 35630, United States
Forest Investigative Site 073
Mobile, Alabama, 36608, United States
Forest Investigative Site 272
Mesa, Arizona, 85206, United States
Forest Investigative Site 091
Peoria, Arizona, 85381, United States
Forest Investigative Site 034
Phoenix, Arizona, 85018, United States
Forest Investigative Site 188
Phoenix, Arizona, 85020, United States
Forest Investigative Site 211
Phoenix, Arizona, 85028, United States
Forest Investigative Site 247
Phoenix, Arizona, 85050, United States
Forest Investigative Site 208
Fort Smith, Arkansas, 72901, United States
Forest Investigative Site 101
Little Rock, Arkansas, 72205, United States
Forest Investigative Site 074
Bellflower, California, 90706, United States
Forest Investigative Site 060
Fresno, California, 93721, United States
Forest Investigative Site 329
Fresno, California, 93726, United States
Forest Investigative Site 245
Fullerton, California, 92835, United States
Forest Investigative Site 310
Garden Grove, California, 92844, United States
Forest Investigative Site 297
Lakewood, California, 90712, United States
Forest Investigative Site 116
Long Beach, California, 90822, United States
Forest Investigative Site 085
Los Angeles, California, 90048, United States
Forest Investigative Site 241
Los Angeles, California, 90073, United States
Forest Investigative Site 299
Northridge, California, 91325, United States
Forest Investigative Site 213
Palo Alto, California, 94555, United States
Forest Investigative Site 268
Pismo Beach, California, 93449, United States
Forest Investigative Site 025
Riverside, California, 92506, United States
Forest Investigative Site 143
Roseville, California, 95661, United States
Forest Investigative Site 104
Sacramento, California, 95817, United States
Forest Investigative Site 352
San Diego, California, 92117, United States
Forest Investigative Site 038
San Diego, California, 92120, United States
Forest Investigative Site 326
San Jose, California, 95124, United States
Forest Investigative Site 209
Torrance, California, 90502, United States
Forest Investigative Site 331
Stamford, Connecticut, 06902, United States
Forest Investigative Site 017
Waterbury, Connecticut, 06708, United States
Forest Investigative Site 124
Newark, Delaware, 19713, United States
Forest Investigative Site 196
Brandon, Florida, 33511, United States
Forest Investigative Site 224
Brandon, Florida, 33511, United States
Forest Investigative Site 358
Brandon, Florida, 33511, United States
Forest Investigative Site 166
Chiefland, Florida, 32626, United States
Forest Investigative Site 111
Clearwater, Florida, 33756, United States
Forest Investigative Site 123
Clearwater, Florida, 33765, United States
Forest Investigative Site 291
Coral Gables, Florida, 33134, United States
Forest Investigative Site 239
DeFuniak Springs, Florida, 32435, United States
Forest Investigative Site 001
Fort Lauderdale, Florida, 33316, United States
Forest Investigative Site 165
Fort Walton Beach, Florida, 32547, United States
Forest Investigative Site 102
Gainesville, Florida, 32608, United States
Forest Investigative Site 003
Hollywood, Florida, 33024, United States
Forest Investigative Site 023
Jacksonville, Florida, 32216, United States
Forest Investigative Site 077
Kissimmee, Florida, 34741, United States
Forest Investigative Site 330
Kissimmee, Florida, 34741, United States
Forest Investigative Site 027
Miami, Florida, 33015, United States
Forest Investigative Site 229
Miami, Florida, 33136, United States
Forest Investigative Site 115
Miami, Florida, 33175, United States
Forest Investigative Site 339
Miami, Florida, 33186, United States
Forest Investigative Site 092
Naples, Florida, 34119, United States
Forest Investigative Site 004
Orlando, Florida, 32822, United States
Forest Investigative Site 187
Ormond Beach, Florida, 32174, United States
Forest Investigative Site 069
Pensacola, Florida, 32504, United States
Forest Investigative Site 161
Ponte Vedra, Florida, 32081, United States
Forest Investigative Site 087
Port Orange, Florida, 32127, United States
Forest Investigative Site 109
Saint Cloud, Florida, 34769, United States
Forest Investigative Site 121
St. Petersburg, Florida, 33704, United States
Forest Investigative Site 357
St. Petersburg, Florida, 33744, United States
Forest Investigative Site 002
Tamarac, Florida, 33312, United States
Forest Investigative Site 287
Tampa, Florida, 33607, United States
Forest Investigative Site 052
Tampa, Florida, 33613, United States
Forest Investigative Site 011
Winter Park, Florida, 32789, United States
Forest Investigative Site 348
Winter Park, Florida, 32792, United States
Forest Investigative Site 103
Canton, Georgia, 30114, United States
Forest Investigative Site 292
Dawsonville, Georgia, 30534, United States
Forest Investigative Site 042
Duluth, Georgia, 30096, United States
Forest Investigative Site 140
Gainesville, Georgia, 30501, United States
Forest Investigative Site 030
Lawrenceville, Georgia, 30046, United States
Forest Investigative Site 321
Woodstock, Georgia, 30189, United States
Forest Investigative Site 008
Coeur d'Alene, Idaho, 83814, United States
Forest Investigative Site 119
Eagle, Idaho, 83616, United States
Forest Investigative Site 201
Bolingbrook, Illinois, 60490, United States
Forest Investigative Site 206
Downers Grove, Illinois, 60515, United States
Forest Investigative Site 136
Elk Grove Village, Illinois, 60007, United States
Forest Investigative Site 139
Oak Lawn, Illinois, 60453, United States
Forest Investigative Site 227
Peoria, Illinois, 61637, United States
Forest Investigative Site 334
Springfield, Illinois, 62703, United States
Forest Investigative Site 263
Elwood, Indiana, 46036, United States
Forest Investigative Site 342
Lafayette, Indiana, 47904, United States
Forest Investigative Site 293
Michigan City, Indiana, 46360, United States
Forest Investigative Site 264
Muncie, Indiana, 47303, United States
Forest Investigative Site 135
Council Bluffs, Iowa, 51503, United States
Forest Investigative Site 256
Iowa City, Iowa, 52242, United States
Forest Investigative Site 214
Olathe, Kansas, 66061, United States
Forest Investigative Site 316
Topeka, Kansas, 66606, United States
Forest Investigative Site 301
Wichita, Kansas, 67205, United States
Forest Investigative Site 051
Bowling Green, Kentucky, 42101, United States
Forest Investigative Site 075
Crescent Springs, Kentucky, 41017, United States
Forest Investigative Site 351
Hazard, Kentucky, 41701, United States
Forest Investigative Site 068
Lexington, Kentucky, 40504, United States
Forest Investigative Site 088
Louisville, Kentucky, 40215, United States
Forest Investigative Site 053
Owensboro, Kentucky, 42303, United States
Forest Investigative Site 273
Lafayette, Louisiana, 70503, United States
Forest Investigative Site 070
Opelousas, Louisiana, 70570, United States
Forest Investigative Site 097
Sunset, Louisiana, 70584, United States
Forest Investigative Site 128
Lewiston, Maine, 04240, United States
Forest Investigative Site 248
Baltimore, Maryland, 21224, United States
Forest Investigative Site 020
Columbia, Maryland, 21044, United States
Forest Investigative Site 072
Towson, Maryland, 21204, United States
Forest Investigative Site 106
Fall River, Massachusetts, 02720, United States
Forest Investigative Site 044
North Dartmouth, Massachusetts, 02747, United States
Forest Investigative Site 350
Pittsfield, Massachusetts, 01201, United States
Forest Investigative Site 157
Ann Arbor, Michigan, 48106, United States
Forest Investigative Site 341
Detroit, Michigan, 48202, United States
Forest Investigative Site 328
Kalamazoo, Michigan, 49009, United States
Forest Investigative Site 063
Livonia, Michigan, 48152, United States
Forest Investigative Site 322
Saint Joseph, Michigan, 49085, United States
Forest Investigative Site 303
Edina, Minnesota, 55435, United States
Forest Investigative Site 056
Fridley, Minnesota, 55432, United States
Forest Investigative Site 082
Rochester, Minnesota, 55905, United States
Forest Investigative Site 033
Chesterfield, Missouri, 63017, United States
Forest Investigative Site 098
Saint Charles, Missouri, 63301, United States
Forest Investigative Site 117
Springfield, Missouri, 65803, United States
Forest Investigative Site 186
St Louis, Missouri, 63141, United States
Forest Investigative Site 288
St Louis, Missouri, 63143, United States
Forest Investigative Site 333
Butte, Montana, 59701, United States
Forest Investigative Site 029
Missoula, Montana, 59808, United States
Forest Investigative Site 197
Bellevue, Nebraska, 68123, United States
Forest Investigative Site 267
Fremont, Nebraska, 68025, United States
Forest Investigative Site 337
Fremont, Nebraska, 68028, United States
Forest Investigative Site 315
Lincoln, Nebraska, 68506, United States
Forest Investigative Site 108
Lincoln, Nebraska, 68510, United States
Forest Investigative Site 345
Omaha, Nebraska, 68114, United States
Forest Investigative Site 079
Henderson, Nevada, 89014, United States
Forest Investigative Site 270
Henderson, Nevada, 89052, United States
Forest Investigative Site 067
Cherry Hill, New Jersey, 08003, United States
Forest Investigative Site 327
Clifton, New Jersey, 07012, United States
Forest Investigative Site 144
Hackensack, New Jersey, 07601, United States
Forest Investigative Site 317
Summit, New Jersey, 07901, United States
Forest Investigative Site 226
Brooklyn, New York, 11229, United States
Forest Investigative Site 199
Great Neck, New York, 11021, United States
Forest Investigative Site 071
New York, New York, 10029, United States
Forest Investigative Site 013
Rochester, New York, 14618, United States
Forest Investigative Site 066
Syracuse, New York, 13210, United States
Forest Investigative Site 158
West Seneca, New York, 14224, United States
Forest Investigative Site 313
Asheville, North Carolina, 28801, United States
Forest Investigative Site 193
Burlington, North Carolina, 27215, United States
Forest Investigative Site 142
Charlotte, North Carolina, 28207, United States
Forest Investigative Site 259
Charlotte, North Carolina, 28277, United States
Forest Investigative Site 019
Elizabeth City, North Carolina, 27909, United States
Forest Investigative Site 318
Shelby, North Carolina, 28150, United States
Forest Investigative Site 078
Shelby, North Carolina, 28152, United States
Forest Investigative Site 176
Wilmington, North Carolina, 28451, United States
Forest Investigative Site 282
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site 314
Winston-Salem, North Carolina, 27103, United States
Forest Investigative Site 164
Canton, Ohio, 44718, United States
Forest Investigative Site 149
Cincinnati, Ohio, 45219, United States
Forest Investigative Site 061
Cincinnati, Ohio, 45231, United States
Forest Investigative Site 040
Cincinnati, Ohio, 45242, United States
Forest Investigative Site 280
Cincinnati, Ohio, 45267, United States
Forest Investigative Site 009
Columbus, Ohio, 43213, United States
Forest Investigative Site 353
Dayton, Ohio, 45439, United States
Forest Investigative Site 059
Marion, Ohio, 43302, United States
Forest Investigative Site 154
Marion, Ohio, 43302, United States
Forest Investigative Site 346
Toledo, Ohio, 43606, United States
Forest Investigative Site 105
Zanesville, Ohio, 43701, United States
Forest Investigative Site 167
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 281
Oklahoma City, Oklahoma, 73103, United States
Forest Investigative Site 236
Tulsa, Oklahoma, 74135, United States
Forest Investigative Site 285
Medford, Oregon, 97501, United States
Forest Investigative Site 289
Portland, Oregon, 97220, United States
Forest Investigative Site 218
Portland, Oregon, 97227, United States
Forest Investigative Site 086
Altoona, Pennsylvania, 16601, United States
Forest Investigative Site 340
Beaver, Pennsylvania, 15009, United States
Forest Investigative Site 120
Downingtown, Pennsylvania, 19335, United States
Forest Investigative Site 062
Erie, Pennsylvania, 16506, United States
Forest Investigative Site 277
Norristown, Pennsylvania, 19401, United States
Forest Investigative Site 230
Philadelphia, Pennsylvania, 19107, United States
Forest Investigative Site 205
Philadelphia, Pennsylvania, 19140, United States
Forest Investigative Site 336
Pittsburgh, Pennsylvania, 15221, United States
Forest Investigative Site 364
Pittsburgh, Pennsylvania, 15240, United States
Forest Investigative Site 344
Pittsburgh, Pennsylvania, 15243, United States
Forest Investigative Site 010
Tipton, Pennsylvania, 16684, United States
Forest Investigative Site 064
Uniontown, Pennsylvania, 15401, United States
Forest Investigative Site 228
Johnston, Rhode Island, 02919, United States
Forest Investigative Site 283
Lincoln, Rhode Island, 02865, United States
Forest Investigative Site 365
Providence, Rhode Island, 02903, United States
Forest Investigative Site 305
Charleston, South Carolina, 29406, United States
Forest Investigative Site 093
Easley, South Carolina, 29640, United States
Forest Investigative Site 257
Fort Mill, South Carolina, 29707, United States
Forest Investigative Site 233
Gaffney, South Carolina, 29340, United States
Forest Investigative Site 110
Greenville, South Carolina, 29615, United States
Forest Investigative Site 300
Pelzer, South Carolina, 29669, United States
Forest Investigative Site 204
Rock Hill, South Carolina, 29732, United States
Forest Investigative Site 021
Spartanburg, South Carolina, 29303, United States
Forest Investigative Site 012
Union, South Carolina, 29379, United States
Forest Investigative Site 058
Rapid City, South Dakota, 57702, United States
Forest Investigative Site 223
Bristol, Tennessee, 37620, United States
Forest Investigative Site 050
Fayetteville, Tennessee, 37334, United States
Forest Investigative Site 253
Shelbyville, Tennessee, 37160, United States
Forest Investigative Site 024
Arlington, Texas, 76012, United States
Forest Investigative Site 177
Boerne, Texas, 78006, United States
Forest Investigative Site 090
Corsicana, Texas, 75110, United States
Forest Investigative Site 172
Dallas, Texas, 75246, United States
Forest Investigative Site 237
Houston, Texas, 77030, United States
Forest Investigative Site 271
Houston, Texas, 77030, United States
Forest Investigative Site 370
Houston, Texas, 77030, United States
Forest Investigative Site 195
Houston, Texas, 77034, United States
Forest Investigative Site 312
Houston, Texas, 77079, United States
Forest Investigative Site 332
Huntsville, Texas, 77340, United States
Forest Investigative Site 232
Longview, Texas, 75605, United States
Forest Investigative Site 049
Tyler, Texas, 75708, United States
Forest Investigative Site 181
Colchester, Vermont, 05446, United States
Forest Investigative Site 125
Abingdon, Virginia, 24210, United States
Forest Investigative Site 202
Richmond, Virginia, 23225, United States
Forest Investigative Site 231
Richmond, Virginia, 23229, United States
Forest Investigative Site 045
Richmond, Virginia, 23233, United States
Forest Investigative Site 184
Spokane, Washington, 99202, United States
Forest Investigative Site 174
Spokane, Washington, 99204, United States
Forest Investigative Site 217
Tacoma, Washington, 98405, United States
Forest Investigative Site 335
Charleston, West Virginia, 25304, United States
Forest Investigative Site 319
Morgantown, West Virginia, 26505, United States
Forest Investigative Site 146
West Allis, Wisconsin, 53227, United States
Forest Investigative Site 403
Buenos Aires, Buenos Aires, B1842DID, Argentina
Forest Investigative Site 418
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425DES, Argentina
Forest Investigative Site 402
Florida, Buenos Aires, B1602DOH, Argentina
Forest Investigative Site 405
La Plata, Buenos Aires, 1900, Argentina
Forest Investigative Site 406
Lanús Este, Buenos Aires, B1824 KAJ, Argentina
Forest Investigative Site 413
Mar del Plata, Buenos Aires, CP 7600, Argentina
Forest Investigative Site 407
Paraná, Entre Ríos Province, E3100BHK, Argentina
Forest Investigative Site 404
Mendoza, Mendoza Province, M5500CCG, Argentina
Forest Investigative Site 412
Rosario, Santa Fe Province, S2000DBS, Argentina
Forest Investigative Site 409
Rosario, Santa Fe Province, S2000KZD, Argentina
Forest Investigative Site 411
Buenos Aires, C1015ABO, Argentina
Forest Investigative Site 414
Buenos Aires, C1122AAK, Argentina
Forest Investigative Site 419
Buenos Aires, C1426ABP, Argentina
Forest Investigative Site 416
Buenos Aires, C1428DDE, Argentina
Forest Investigative Site 415
Derqui Pilar - Buenos Aires, B1629ODT, Argentina
Forest Investigative Site 417
La Plata, 1900, Argentina
Forest Investigative Site 420
Mendoza, 5500, Argentina
Forest Investigative Site 410
San Juan Bautista, 1888, Argentina
Forest Investigative Site 401
San Miguel de Tucumán, T4000IFL, Argentina
Forest Investigative Site 408
Santa Fe, 3000, Argentina
Forest Investigative Site 235
Calgary, Alberta, T2K5R7, Canada
Forest Investigative Site 162
North Vancouver, British Columbia, V7M 2H9, Canada
Forest Investigative Site 302
Burlington, Ontario, L7N 3V2, Canada
Forest Investigative Site 185
Montreal, Quebec, H2R 1V6, Canada
Forest Investigative Site 127
Saskatoon, Saskatchewan, S7N0W8, Canada
Forest Investigative Site 421
Talcahuano, 4270918, Chile
Forest Investigative Site 442
Bogotá, 111111, Colombia
Forest Investigative Site 443
Bogotá, 111711, Colombia
Forest Investigative Site 461
Chieti, 66013, Italy
Forest Investigative Site 464
Roma, 00168, Italy
Forest Investigative Site 505
Batu Caves, 68100, Malaysia
Forest Investigative Site 501
Kuala Lumpur, 50588, Malaysia
Forest Investigative Site 504
Kuala Lumpur, 59100, Malaysia
Forest Investigative Site 502
Kuantan, 25100, Malaysia
Forest Investigative Site 522
Monterrey, Nuevo León, 64460, Mexico
Forest Investigative Site 526
Mérida, Yucatán, 97070, Mexico
Forest Investigative Site 524
Guadalajara, 44100, Mexico
Forest Investigative Site 521
Monterrey, 64060, Mexico
Forest Investigative Site 543
Bellavista, Callao 2, Peru
Forest Investigative Site 550
Lima, Lima 11, Peru
Forest Investigative Site 551
Lima, Lima 13, Peru
Forest Investigative Site 545
Lima, Lima 18, Peru
Forest Investigative Site 546
Lima, Lima 27, Peru
Forest Investigative Site 549
Lima, Lima 31, Peru
Forest Investigative Site 544
Lima, Lima 33, Peru
Forest Investigative Site 541
Pueblo Libre, Lima 21, Peru
Forest Investigative Site 569
Cavite, 4114, Philippines
Forest Investigative Site 567
Iloilo City, 5000, Philippines
Forest Investigative Site 568
Iloilo City, 5000, Philippines
Forest Investigative Site 565
Manila, 1000, Philippines
Forest Investigative Site 563
Pasig, 1600, Philippines
Forest Investigative Site 562
Quezon City, 1100, Philippines
Forest Investigative Site 564
Quezon City, 1100, Philippines
Forest Investigative Site 566
Quezon City, 1109, Philippines
Forest Investigative Site 561
Quezon City, 1118, Philippines
Forest Investigative Site 585
Brasov, 500112, Romania
Forest Investigative Site 586
Bucharest, 10457, Romania
Forest Investigative Site 587
Bucharest, 30303, Romania
Forest Investigative Site 588
Bucharest, 31298, Romania
Forest Investigative Site 584
Bucharest, 50159, Romania
Forest Investigative Site 582
Bucharest, 50554, Romania
Forest Investigative Site 581
Iași, 700115, Romania
Forest Investigative Site 583
Iași, 700115, Romania
Forest Investigative Site 608
Barnaul, 656045, Russia
Forest Investigative Site 602
Kazan', 420015, Russia
Forest Investigative Site 618
Kemerovo, 650000, Russia
Forest Investigative Site 609
Krasnodar, 350012, Russia
Forest Investigative Site 614
Krasnoyarsk, 660022, Russia
Forest Investigative Site 617
Moscow, 125367, Russia
Forest Investigative Site 605
Novosibirsk, 630099, Russia
Forest Investigative Site 606
Saint Petersburg, 191025, Russia
Forest Investigative Site 612
Saint Petersburg, 193231, Russia
Forest Investigative Site 619
Saint Petersburg, 194044, Russia
Forest Investigative Site 604
Saint Petersburg, 194358, Russia
Forest Investigative Site 611
Saint Petersburg, 196084, Russia
Forest Investigative Site 610
Saint Petersburg, 196247, Russia
Forest Investigative Site 601
Saint Petersburg, 197110, Russia
Forest Investigative Site 600
Saint Petersburg, 197706, Russia
Forest Investigative Site 607
Tomsk, 634063, Russia
Forest Investigative Site 620
Yaroslavl, 150003, Russia
Forest Investigative Site 629
Knez-Selo, Nišava District, 18204, Serbia
Forest Investigative Site 622
Belgrade, 11000, Serbia
Forest Investigative Site 623
Belgrade, 11000, Serbia
Forest Investigative Site 624
Belgrade, 11000, Serbia
Forest Investigative Site 625
Belgrade, 11000, Serbia
Forest Investigative Site 627
Kamenitz, 21204, Serbia
Forest Investigative Site 628
Kragujevac, 34000, Serbia
Forest Investigative Site 641
Cadiz, 11009, Spain
Forest Investigative Site 647
Loja, 18300, Spain
Forest Investigative Site 644
Salt, 17190, Spain
Forest Investigative Site 723
Kaohsiung Hsien, 833, Taiwan
Forest Investigative Site 724
Puzih City, 61363, Taiwan
Forest Investigative Site 725
Taipei, 100, Taiwan
Forest Investigative Site 722
Taipei, 11490, Taiwan
Forest Investigative Site 662
Hat Yai, Changwat Songkhla, 90110, Thailand
Forest Investigative Site 664
Bangkok, 10400, Thailand
Forest Investigative Site 663
Bangkok, 11000, Thailand
Forest Investigative Site 661
Muang, 40002, Thailand
Forest Investigative Site 699
Cherkasy, 18009, Ukraine
Forest Investigative Site 691
Dnipropetrovsk, 49074, Ukraine
Forest Investigative Site 692
Donetsk, 83003, Ukraine
Forest Investigative Site 689
Donetsk, 83099, Ukraine
Forest Investigative Site 690
Ivano-Frankivsk, 76018, Ukraine
Forest Investigative Site 697
Kharkiv, 61035, Ukraine
Forest Investigative Site 693
Kharkiv, 61039, Ukraine
Forest Investigative Site 682
Kharkiv, 61124, Ukraine
Forest Investigative Site 709
Kremenchuk, Ukraine
Forest Investigative Site 698
Kyiv, 3049, Ukraine
Forest Investigative Site 683
Kyiv, 3680, Ukraine
Forest Investigative Site 684
Kyiv, 3680, Ukraine
Forest Investigative Site 687
Kyiv, 3680, Ukraine
Forest Investigative Site 685
Kyiv, 4050, Ukraine
Forest Investigative Site 681
Lviv, 79013, Ukraine
Forest Investigative Site 708
Mykolayiv, 54003, Ukraine
Forest Investigative Site 706
Poltava, 36038, Ukraine
Forest Investigative Site 695
Sumy, 40000, Ukraine
Forest Investigative Site 707
Vinnitsa, 21001, Ukraine
Forest Investigative Site 688
Zaporizhzhia, 69600, Ukraine
Forest Investigative Site 696
Zaporizhzhya, 69035, Ukraine
Forest Investigative Site 694
Zaporizhzhya, 69106, Ukraine
Forest Investigative Site 705
Zaporizhzhya, 69118, Ukraine
Related Publications (3)
Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.
PMID: 29763572DERIVEDKarpefors M, Weatherall J. The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials. J Am Med Inform Assoc. 2018 Aug 1;25(8):1069-1073. doi: 10.1093/jamia/ocy016.
PMID: 29579254DERIVEDMartinez FJ, Rabe KF, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VK, Siddiqui S, Rekeda L, Miller CJ, Zetterstrand S, Reisner C, Rennard SI. Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting beta2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Sep 1;194(5):559-67. doi: 10.1164/rccm.201607-1349OC.
PMID: 27585384DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical Study Information Center
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2011
First Posted
September 30, 2011
Study Start
September 30, 2011
Primary Completion
November 30, 2015
Study Completion
January 31, 2016
Last Updated
April 13, 2017
Results First Posted
January 25, 2017
Record last verified: 2017-03