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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Forest Laboratories
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: May 6, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
COPD
COPD Exacerbation
Lung Diseases
Respiratory Disorders
Pulmonary Disease
Chronic Obstructive Lung Diseases
Chronic Obstructive Airway Disease
Drug: Roflumilast
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group 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)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Rate of moderate or severe COPD exacerbations per subject per year [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prebronchodilator Forced Expiratory Volume in 1 second (FEV1) in Liters [ Time Frame: Change from randomization, Week 0 (Visit 2) to Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2300
Study Start Date: September 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Roflumilast
Drug: Roflumilast
Roflumilast 500 µg, oral administration, once per day
Other Name: Daliresp
Placebo Comparator: 2
Placebo
Drug: Placebo
Dose-matched placebo, oral administration, once per day.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Male or female patients at least 40 years of age
  • 2. History of COPD (according to 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443845

Contacts
Contact: Sandra Beaird, PhD 1-800-678-1605 ext 66297 FRXClinTrials@frx.com

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site 081 Terminated
Anniston, Alabama, United States, 36207
Forest Investigative Site 065 Recruiting
Athens, Alabama, United States, 35611
Forest Investigative Site 031 Completed
Birmingham, Alabama, United States, 35209
Forest Investigative Site 039 Terminated
Birmingham, Alabama, United States, 35216
Forest Investigative Site 131 Terminated
Florence, Alabama, United States, 35630
Forest Investigative Site 225 Terminated
Gulf Shores, Alabama, United States, 36542
Forest Investigative Site 073 Terminated
Mobile, Alabama, United States, 36608
United States, Arizona
Forest Investigative Site 311 Terminated
Glendale, Arizona, United States, 85306
Forest Investigative Site 272 Terminated
Mesa, Arizona, United States, 85206
Forest Investigative Site 091 Active, not recruiting
Peoria, Arizona, United States, 85381
Forest Investigative Site 170 Terminated
Phoenix, Arizona, United States, 85008
Forest Investigative Site 266 Terminated
Phoenix, Arizona, United States, 85020
Forest Investigative Site 211 Active, not recruiting
Phoenix, Arizona, United States, 85028
Forest Investigative Site 034 Active, not recruiting
Phoenix, Arizona, United States, 85018
Forest Investigative Site 188 Terminated
Phoenix, Arizona, United States, 85020
Forest Investigative Site 298 Completed
Phoenix, Arizona, United States, 85012
Forest Investigative Site 247 Recruiting
Phoenix, Arizona, United States, 85050
United States, Arkansas
Forest Investigative Site 208 Recruiting
Fort Smith, Arkansas, United States, 72901
Forest Investigative Site 101 Active, not recruiting
Little Rock, Arkansas, United States, 72205
Forest Investigative Site 222 Terminated
Searcy, Arkansas, United States, 72143
United States, California
Forest Investigative Site 159 Completed
Anaheim, California, United States, 92801
Forest Investigative Site 074 Active, not recruiting
Bellflower, California, United States, 90706
Forest Investigative Site 371 Terminated
Corona, California, United States, 92880
Forest Investigative Site 048 Terminated
Fountain Valley, California, United States, 92708
Forest Investigative Site 060 Recruiting
Fresno, California, United States, 93721
Forest Investigative Site 329 Recruiting
Fresno, California, United States, 93726
Forest Investigative Site 245 Active, not recruiting
Fullerton, California, United States, 92835
Forest Investigative Site 310 Recruiting
Garden Grove, California, United States, 92844
Forest Investigative Site 057 Terminated
La Jolla, California, United States, 92093
Forest Investigative Site 297 Active, not recruiting
Lakewood, California, United States, 90712
Forest Investigative Site 126 Withdrawn
Loma Linda, California, United States, 92357
Forest Investigative Site 116 Recruiting
Long Beach, California, United States, 90822
Forest Investigative Site 244 Terminated
Los Angeles, California, United States, 90095
Forest Investigative Site 279 Withdrawn
Los Angeles, California, United States, 90033
Forest Investigative Site 085 Recruiting
Los Angeles, California, United States, 90048
Forest Investigative Site 241 Recruiting
Los Angeles, California, United States, 90073
Forest Investigative Site 299 Recruiting
Northridge, California, United States, 91325
Forest Investigative Site 274 Completed
Palm Springs, California, United States, 92262
Forest Investigative Site 320 Terminated
Palmdale, California, United States, 93551
Forest Investigative Site 213 Recruiting
Palo Alto, California, United States, 94555
Forest Investigative Site 016 Terminated
Paramount, California, United States, 90723
Forest Investigative Site 268 Recruiting
Pismo Beach, California, United States, 93449
Forest Investigative Site 183 Completed
Poway, California, United States, 92064
Forest Investigative Site 025 Recruiting
Riverside, California, United States, 92506
Forest Investigative Site 143 Recruiting
Roseville, California, United States, 95661
Forest Investigative Site 104 Recruiting
Sacramento, California, United States, 95817
Forest Investigative Site 038 Recruiting
San Diego, California, United States, 92120
Forest Investigative Site 352 Recruiting
San Diego, California, United States, 92117
Forest Investigative Site 326 Recruiting
San Jose, California, United States, 95124
Forest Investigative Site 080 Terminated
San Jose, California, United States, 95116
Forest Investigative Site 209 Terminated
Torrance, California, United States, 90502
United States, Colorado
Forest Investigative Site 203 Completed
Arvada, Colorado, United States, 80005
Forest Investigative Site 037 Completed
Boulder, Colorado, United States, 80304
Forest Investigative Site 242 Terminated
Colorado Springs, Colorado, United States, 80906
Forest Investigative Site 089 Terminated
Denver, Colorado, United States, 80206
United States, Connecticut
Forest Investigative Site 331 Recruiting
Stamford, Connecticut, United States, 06902
Forest Investigative Site 017 Recruiting
Waterbury, Connecticut, United States, 06708
United States, Delaware
Forest Investigative Site 124 Active, not recruiting
Newark, Delaware, United States, 19713
United States, Florida
Forest Investigative Site 114 Terminated
Brandon, Florida, United States, 33511
Forest Investigative Site 196 Recruiting
Brandon, Florida, United States, 33511
Forest Investigative Site 224 Recruiting
Brandon, Florida, United States, 33511
Forest Investigative Site 358 Recruiting
Brandon, Florida, United States, 33511
Forest Investigative Site 166 Terminated
Chiefland, Florida, United States, 32626
Forest Investigative Site 111 Recruiting
Clearwater, Florida, United States, 33756
Forest Investigative Site 123 Terminated
Clearwater, Florida, United States, 33765
Forest Investigative Site 291 Recruiting
Coral Gables, Florida, United States, 33134
Forest Investigative Site 192 Terminated
Coral Gables, Florida, United States, 33134
Forest Investigative Site 296 Terminated
Debary, Florida, United States, 32713
Forest Investigative Site 239 Recruiting
DeFuniak Springs, Florida, United States, 32435
Forest Investigative Site 001 Terminated
Fort Lauderdale, Florida, United States, 33316
Forest Investigative Site 165 Terminated
Fort Walton Beach, Florida, United States, 32547
Forest Investigative Site 102 Recruiting
Gainesville, Florida, United States, 32608
Forest Investigative Site 194 Terminated
Gainsville, Florida, United States, 32611
Forest Investigative Site 003 Terminated
Hollywood, Florida, United States, 33024
Forest Investigative Site 023 Recruiting
Jacksonville, Florida, United States, 32216
Forest Investigative Site 077 Terminated
Kissimmee, Florida, United States, 34741
Forest Investigative Site 330 Recruiting
Kissimmee, Florida, United States, 34741
Forest Investigative Site 027 Terminated
Miami, Florida, United States, 33015
Forest Investigative Site 190 Withdrawn
Miami, Florida, United States, 33144
Forest Investigative Site 229 Recruiting
Miami, Florida, United States, 33136
Forest Investigative Site 339 Recruiting
Miami, Florida, United States, 33186
Forest Investigative Site 115 Terminated
Miami, Florida, United States, 33175
Forest Investigative Site 153 Withdrawn
Miami, Florida, United States, 33186
Forest Investigative Site 254 Terminated
Miami, Florida, United States, 33185
Forest Investigative Site 234 Terminated
Miami Springs, Florida, United States, 33166
Forest Investigative Site 018 Withdrawn
Miramar, Florida, United States, 33025
Forest Investigative Site 092 Terminated
Naples, Florida, United States, 34119
Forest Investigative Site 026 Terminated
North Miami Beach, Florida, United States, 33179
Forest Investigative Site 004 Terminated
Orlando, Florida, United States, 32822
Forest Investigative Site 191 Completed
Orlando, Florida, United States, 32803
Forest Investigative Site 187 Terminated
Ormond Beach, Florida, United States, 32174
Forest Investigative Site 284 Completed
Pembroke Pines, Florida, United States, 33029
Forest Investigative Site 309 Terminated
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site 069 Recruiting
Pensacola, Florida, United States, 32504
Forest Investigative Site 161 Recruiting
Ponte Vedra, Florida, United States, 32081
Forest Investigative Site 087 Recruiting
Port Orange, Florida, United States, 32127
Forest Investigative Site 357 Recruiting
Saint Petersburg, Florida, United States, 33744
Forest Investigative Site 109 Terminated
St. Cloud, Florida, United States, 34769
Forest Investigative Site 121 Recruiting
St. Petersburg, Florida, United States, 33704
Forest Investigative Site 002 Recruiting
Tamarac, Florida, United States, 33312
Forest Investigative Site 052 Recruiting
Tampa, Florida, United States, 33613
Forest Investigative Site 287 Recruiting
Tampa, Florida, United States, 33607
Forest Investigative Site 007 Completed
Tampa, Florida, United States, 33603
Forest Investigative Site 295 Terminated
Venice, Florida, United States, 34292
Forest Investigative Site 011 Recruiting
Winter Park, Florida, United States, 32789
Forest Investigative Site 348 Recruiting
Winter Park, Florida, United States, 32792
Forest Investigative Site 096 Terminated
Zephyrhills, Florida, United States, 33542
United States, Georgia
Forest Investigative Site 151 Withdrawn
Atlanta, Georgia, United States, 30329
Forest Investigative Site 216 Terminated
Atlanta, Georgia, United States, 30342
Forest Investigative Site 240 Terminated
Atlanta, Georgia, United States, 30342
Forest Investigative Site 041 Terminated
Austell, Georgia, United States, 30106
Forest Investigative Site 103 Terminated
Canton, Georgia, United States, 30114
Forest Investigative Site 292 Completed
Dawsonville, Georgia, United States, 30534
Forest Investigative Site 276 Terminated
Decatur, Georgia, United States, 30033
Forest Investigative Site 042 Recruiting
Duluth, Georgia, United States, 30096
Forest Investigative Site 140 Recruiting
Gainesville, Georgia, United States, 30501
Forest Investigative Site 030 Recruiting
Lawrenceville, Georgia, United States, 30046
Forest Investigative Site 321 Terminated
Woodstock, Georgia, United States, 30189
United States, Hawaii
Forest Investigative Site 178 Terminated
Honolulu, Hawaii, United States, 96814
United States, Idaho
Forest Investigative Site 008 Recruiting
Coeur d' Alene, Idaho, United States, 83814
Forest Investigative Site 119 Recruiting
Eagle, Idaho, United States, 83616
United States, Illinois
Forest Investigative Site 201 Terminated
Bolingbrook, Illinois, United States, 60490
Forest Investigative Site 206 Recruiting
Downers Grove, Illinois, United States, 60515
Forest Investigative Site 136 Completed
Elk Grove Village, Illinois, United States, 60007
Forest Investigative Site 014 Terminated
Maywood, Illinois, United States, 60153
Forest Investigative Site 200 Terminated
Normal, Illinois, United States, 61761
Forest Investigative Site 173 Completed
O'Fallon, Illinois, United States, 62269
Forest Investigative Site 139 Terminated
Oak Lawn, Illinois, United States, 60453
Forest Investigative Site 246 Terminated
Oak Park, Illinois, United States, 60302
Forest Investigative Site 227 Recruiting
Peoria, Illinois, United States, 61637
Forest Investigative Site 141 Terminated
Springfield, Illinois, United States, 62702
Forest Investigative Site 334 Recruiting
Springfield, Illinois, United States, 62703
United States, Indiana
Forest Investigative Site 263 Recruiting
Elwood, Indiana, United States, 46036
Forest Investigative Site 342 Recruiting
Lafayette, Indiana, United States, 47904
Forest Investigative Site 293 Active, not recruiting
Michigan City, Indiana, United States, 46360
Forest Investigative Site 264 Recruiting
Muncie, Indiana, United States, 47303
Forest Investigative Site 043 Terminated
South Bend, Indiana, United States, 46617
United States, Iowa
Forest Investigative Site 135 Recruiting
Council Bluffs, Iowa, United States, 51503
Forest Investigative Site 255 Completed
Iowa City, Iowa, United States, 52240
Forest Investigative Site 256 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Forest Investigative Site 163 Completed
Lansing, Kansas, United States, 66043
Forest Investigative Site 214 Recruiting
Olathe, Kansas, United States, 66061
Forest Investigative Site 316 Recruiting
Topeka, Kansas, United States, 66606
Forest Investigative Site 301 Active, not recruiting
Wichita, Kansas, United States, 67205
United States, Kentucky
Forest Investigative Site 051 Recruiting
Bowling Green, Kentucky, United States, 42101
Forest Investigative Site 075 Active, not recruiting
Crescent Springs, Kentucky, United States, 41017
Forest Investigative Site 351 Recruiting
Hazard, Kentucky, United States, 41701
Forest Investigative Site 068 Terminated
Lexington, Kentucky, United States, 40504
Forest Investigative Site 275 Terminated
Lexington, Kentucky, United States, 40536
Forest Investigative Site 207 Terminated
Louisville, Kentucky, United States, 40217
Forest Investigative Site 088 Terminated
Louisville, Kentucky, United States, 40215
Forest Investigative Site 053 Terminated
Owensboro, Kentucky, United States, 42303
Forest Investigative Site 152 Withdrawn
Paducah, Kentucky, United States, 42003
United States, Louisiana
Forest Investigative Site 273 Recruiting
Lafayette, Louisiana, United States, 70503
Forest Investigative Site 070 Recruiting
Opelousas, Louisiana, United States, 70570
Forest Investigative Site 097 Recruiting
Sunset, Louisiana, United States, 70584
United States, Maine
Forest Investigative Site 128 Completed
Lewiston, Maine, United States, 04240
United States, Maryland
Forest Investigative Site 248 Recruiting
Baltimore, Maryland, United States, 21224
Forest Investigative Site 020 Recruiting
Columbia, Maryland, United States, 21044
Forest Investigative Site 072 Recruiting
Towson, Maryland, United States, 21204
United States, Massachusetts
Forest Investigative Site 106 Recruiting
Fall River, Massachusetts, United States, 02720
Forest Investigative Site 044 Recruiting
North Dartmouth, Massachusetts, United States, 02747
Forest Investigative Site 350 Recruiting
Pittsfield, Massachusetts, United States, 01201
United States, Michigan
Forest Investigative Site 157 Recruiting
Ann Arbor, Michigan, United States, 48106
Forest Investigative Site 099 Terminated
Bay City, Michigan, United States, 48706
Forest Investigative Site 180 Withdrawn
Clarkston, Michigan, United States, 48346
Forest Investigative Site 262 Not yet recruiting
Detroit, Michigan, United States, 48235
Forest Investigative Site 341 Recruiting
Detroit, Michigan, United States, 48202
Forest Investigative Site 328 Recruiting
Kalamazoo, Michigan, United States, 49009
Forest Investigative Site 063 Recruiting
Livonia, Michigan, United States, 48152
Forest Investigative Site 238 Terminated
Pinconning, Michigan, United States, 48605
Forest Investigative Site 322 Recruiting
Saint Joseph, Michigan, United States, 49085
Forest Investigative Site 035 Terminated
Stevensville, Michigan, United States, 49127
United States, Minnesota
Forest Investigative Site 303 Recruiting
Edina, Minnesota, United States, 55435
Forest Investigative Site 056 Completed
Fridley, Minnesota, United States, 55432
Forest Investigative Site 198 Terminated
Minneapolis, Minnesota, United States, 55402
Forest Investigative Site 212 Terminated
Plymouth, Minnesota, United States, 55441
Forest Investigative Site 082 Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Forest Investigative Site 033 Recruiting
Chesterfield, Missouri, United States, 63017
Forest Investigative Site 094 Terminated
Jefferson City, Missouri, United States, 65109
Forest Investigative Site 117 Active, not recruiting
Springfield, Missouri, United States, 65803
Forest Investigative Site 098 Recruiting
St. Charles, Missouri, United States, 63301
Forest Investigative Site 084 Terminated
St. Louis, Missouri, United States, 63141
Forest Investigative Site 186 Recruiting
St. Louis, Missouri, United States, 63141
Forest Investigative Site 288 Recruiting
St. Louis, Missouri, United States, 63143
United States, Montana
Forest Investigative Site 333 Recruiting
Butte, Montana, United States, 59701
Forest Investigative Site 029 Recruiting
Missoula, Montana, United States, 59808
United States, Nebraska
Forest Investigative Site 197 Recruiting
Bellevue, Nebraska, United States, 68123
Forest Investigative Site 337 Recruiting
Fremont, Nebraska, United States, 68028
Forest Investigative Site 267 Recruiting
Fremont, Nebraska, United States, 68025
Forest Investigative Site 046 Terminated
Fremont, Nebraska, United States, 68025
Forest Investigative Site 290 Terminated
Lincoln, Nebraska, United States, 68521
Forest Investigative Site 108 Recruiting
Lincoln, Nebraska, United States, 68510
Forest Investigative Site 315 Active, not recruiting
Lincoln, Nebraska, United States, 68506
Forest Investigative Site 345 Terminated
Omaha, Nebraska, United States, 68114
Forest Investigative Site 022 Terminated
Omaha, Nebraska, United States, 68114
United States, Nevada
Forest Investigative Site 079 Recruiting
Henderson, Nevada, United States, 89014
Forest Investigative Site 270 Active, not recruiting
Henderson, Nevada, United States, 89052
Forest Investigative Site 251 Withdrawn
Las Vegas, Nevada, United States, 89102
Forest Investigative Site 252 Terminated
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Forest Investigative Site 138 Terminated
Newington, New Hampshire, United States, 03801
United States, New Jersey
Forest Investigative Site 067 Active, not recruiting
Cherry Hill, New Jersey, United States, 08003
Forest Investigative Site 327 Recruiting
Clifton, New Jersey, United States, 07012
Forest Investigative Site 144 Recruiting
Hackensack, New Jersey, United States, 07601
Forest Investigative Site 306 Terminated
Ocean, New Jersey, United States, 07712
Forest Investigative Site 317 Recruiting
Summit, New Jersey, United States, 07901
United States, New Mexico
Forest Investigative Site 032 Terminated
Albuquerque, New Mexico, United States, 87106
Forest Investigative Site 076 Completed
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site 133 Withdrawn
Brooklyn, New York, United States, 11234
Forest Investigative Site 226 Recruiting
Brooklyn, New York, United States, 11229
Forest Investigative Site 286 Terminated
Corning, New York, United States, 14830
Forest Investigative Site 169 Terminated
Glens Falls, New York, United States, 12801
Forest Investigative Site 199 Terminated
Great Neck, New York, United States, 11021
Forest Investigative Site 047 Withdrawn
New York, New York, United States, 100003
Forest Investigative Site 071 Active, not recruiting
New York, New York, United States, 10029
Forest Investigative Site 083 Withdrawn
New York, New York, United States, 10016
Forest Investigative Site 013 Terminated
Rochester, New York, United States, 14618
Forest Investigative Site 066 Active, not recruiting
Syracuse, New York, United States, 13210
Forest Investigative Site 158 Active, not recruiting
West Seneca, New York, United States, 14224
Forest Investigative Site 215 Not yet recruiting
Williamsville, New York, United States, 14221
United States, North Carolina
Forest Investigative Site 313 Recruiting
Asheville, North Carolina, United States, 28801
Forest Investigative Site 193 Recruiting
Burlington, North Carolina, United States, 27215
Forest Investigative Site 168 Terminated
Calabash, North Carolina, United States, 28467
Forest Investigative Site 219 Withdrawn
Charlotte, North Carolina, United States, 28210
Forest Investigative Site 259 Terminated
Charlotte, North Carolina, United States, 28277
Forest Investigative Site 142 Recruiting
Charlotte, North Carolina, United States, 28207
Forest Investigative Site 019 Recruiting
Elizabeth City, North Carolina, United States, 27909
Forest Investigative Site 054 Withdrawn
Greensboro, North Carolina, United States, 27410
Forest Investigative Site 148 Completed
Hickory, North Carolina, United States, 28602
Forest Investigative Site 269 Not yet recruiting
Huntersville, North Carolina, United States, 28078
Forest Investigative Site 318 Active, not recruiting
Shelby, North Carolina, United States, 28150
Forest Investigative Site 078 Recruiting
Shelby, North Carolina, United States, 28152
Forest Investigative Site 176 Recruiting
Wilmington, North Carolina, United States, 28451
Forest Investigative Site 314 Terminated
Winston Salem, North Carolina, United States, 27103
Forest Investigative Site 258 Terminated
Winston Salem, North Carolina, United States, 28277
Forest Investigative Site 189 Terminated
Winston-Salem, North Carolina, United States, 27103
Forest Investigative Site 282 Recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Forest Investigative Site 122 Completed
Akron, Ohio, United States, 44313
Forest Investigative Site 164 Recruiting
Canton, Ohio, United States, 44718
Forest Investigative Site 061 Recruiting
Cincinatti, Ohio, United States, 45231
Forest Investigative Site 040 Recruiting
Cincinnati, Ohio, United States, 45242
Forest Investigative Site 149 Recruiting
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 280 Recruiting
Cincinnati, Ohio, United States, 45267
Forest Investigative Site 095 Withdrawn
Cleveland, Ohio, United States, 44106
Forest Investigative Site 009 Recruiting
Columbus, Ohio, United States, 43213
Forest Investigative Site 353 Recruiting
Dayton, Ohio, United States, 45439
Forest Investigative Site 059 Active, not recruiting
Marion, Ohio, United States, 43302
Forest Investigative Site 154 Terminated
Marion, Ohio, United States, 43302
Forest Investigative Site 346 Recruiting
Toledo, Ohio, United States, 43606
Forest Investigative Site 105 Terminated
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Forest Investigative Site 167 Terminated
Oklahoma City, Oklahoma, United States, 73103
Forest Investigative Site 281 Recruiting
Oklahoma City, Oklahoma, United States, 73103
Forest Investigative Site 236 Terminated
Tulsa, Oklahoma, United States, 74135
Forest Investigative Site 323 Completed
Tulsa, Oklahoma, United States, 74127
United States, Oregon
Forest Investigative Site 112 Terminated
Corvallis, Oregon, United States, 97330
Forest Investigative Site 304 Terminated
Eugene, Oregon, United States, 97404
Forest Investigative Site 285 Recruiting
Medford, Oregon, United States, 97501
Forest Investigative Site 218 Recruiting
Portland, Oregon, United States, 97227
Forest Investigative Site 289 Recruiting
Portland, Oregon, United States, 97220
United States, Pennsylvania
Forest Investigative Site 134 Terminated
Allentown, Pennsylvania, United States, 18103
Forest Investigative Site 086 Recruiting
Altoona, Pennsylvania, United States, 16601
Forest Investigative Site 132 Terminated
Altoona, Pennsylvania, United States, 16602
Forest Investigative Site 340 Recruiting
Beaver, Pennsylvania, United States, 15009
Forest Investigative Site 130 Withdrawn
Beaver, Pennsylvania, United States, 15009
Forest Investigative Site 155 Terminated
Belle Vernon, Pennsylvania, United States, 15012
Forest Investigative Site 036 Terminated
Belle Vernon, Pennsylvania, United States, 15012
Forest Investigative Site 179 Terminated
Clairton, Pennsylvania, United States, 15025
Forest Investigative Site 120 Active, not recruiting
Downingtown, Pennsylvania, United States, 19335
Forest Investigative Site 062 Recruiting
Erie, Pennsylvania, United States, 16506
Forest Investigative Site 006 Terminated
Hershey, Pennsylvania, United States, 17033
Forest Investigative Site 265 Terminated
Ingomar, Pennsylvania, United States, 15127
Forest Investigative Site 147 Completed
Langhorne, Pennsylvania, United States, 19047
Forest Investigative Site 277 Recruiting
Norristown, Pennsylvania, United States, 19401
Forest Investigative Site 205 Active, not recruiting
Philadelphia, Pennsylvania, United States, 19140
Forest Investigative Site 230 Recruiting
Philadelphia, Pennsylvania, United States, 19107
Forest Investigative Site 250 Withdrawn
Philadelphia, Pennsylvania, United States, 19138
Forest Investigative Site 137 Terminated
Philadelphia, Pennsylvania, United States, 19104
Forest Investigative Site 118 Terminated
Phoenixville, Pennsylvania, United States, 19460
Forest Investigative Site 336 Recruiting
Pittsburgh, Pennsylvania, United States, 15221
Forest Investigative Site 364 Recruiting
Pittsburgh, Pennsylvania, United States, 15240
Forest Investigative Site 344 Recruiting
Pittsburgh, Pennsylvania, United States, 15243
Forest Investigative Site 028 Terminated
Scottdale, Pennsylvania, United States, 15683
Forest Investigative Site 308 Terminated
Shippensburg, Pennsylvania, United States, 17257
Forest Investigative Site 010 Terminated
Tipton, Pennsylvania, United States, 16684
Forest Investigative Site 064 Terminated
Uniontown, Pennsylvania, United States, 15401
Forest Investigative Site 294 Completed
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Forest Investigative Site 129 Terminated
Cumberland, Rhode Island, United States, 02864
Forest Investigative Site 055 Terminated
East Providence, Rhode Island, United States, 02914
Forest Investigative Site 228 Recruiting
Johnston, Rhode Island, United States, 02919
Forest Investigative Site 283 Terminated
Lincoln, Rhode Island, United States, 02865
Forest Investigative Site 365 Recruiting
Providence, Rhode Island, United States, 02903
United States, South Carolina
Forest Investigative Site 015 Terminated
Charleston, South Carolina, United States, 29412
Forest Investigative Site 100 Completed
Charleston, South Carolina, United States, 29407
Forest Investigative Site 305 Recruiting
Charleston, South Carolina, United States, 29406
Forest Investigative Site 093 Recruiting
Easley, South Carolina, United States, 29640
Forest Investigative Site 257 Terminated
Fort Mill, South Carolina, United States, 29707
Forest Investigative Site 233 Recruiting
Gaffney, South Carolina, United States, 29340
Forest Investigative Site 110 Terminated
Greenville, South Carolina, United States, 29615
Forest Investigative Site 243 Terminated
Greenville, South Carolina, United States, 29607
Forest Investigative Site 349 Completed
Greenville, South Carolina, United States, 29615
Forest Investigative Site 300 Active, not recruiting
Pelzer, South Carolina, United States, 29669
Forest Investigative Site 204 Completed
Rock Hill, South Carolina, United States, 29732
Forest Investigative Site 021 Recruiting
Spartanburg, South Carolina, United States, 29303
Forest Investigative Site 012 Recruiting
Union, South Carolina, United States, 29379
United States, South Dakota
Forest Investigative Site 058 Recruiting
Rapid City, South Dakota, United States, 57702
United States, Tennessee
Forest Investigative Site 160 Completed
Brentwood, Tennessee, United States, 37027
Forest Investigative Site 223 Recruiting
Bristol, Tennessee, United States, 37620
Forest Investigative Site 175 Not yet recruiting
Chattanooga, Tennessee, United States, 37404
Forest Investigative Site 050 Recruiting
Fayetteville, Tennessee, United States, 37334
Forest Investigative Site 253 Recruiting
Shelbyville, Tennessee, United States, 37160
United States, Texas
Forest Investigative Site 024 Recruiting
Arlington, Texas, United States, 76012
Forest Investigative Site 177 Recruiting
Boerne, Texas, United States, 78006
Forest Investigative Site 090 Recruiting
Corsicana, Texas, United States, 75110
Forest Investigative Site 172 Recruiting
Dallas, Texas, United States, 75246
Forest Investigative Site 150 Withdrawn
Fort Worth, Texas, United States, 76104
Forest Investigative Site 261 Completed
Houston, Texas, United States, 77030
Forest Investigative Site 237 Terminated
Houston, Texas, United States, 77030
Forest Investigative Site 195 Recruiting
Houston, Texas, United States, 77034
Forest Investigative Site 271 Terminated
Houston, Texas, United States, 77030
Forest Investigative Site 312 Recruiting
Houston, Texas, United States, 77079
Forest Investigative Site 370 Recruiting
Houston, Texas, United States, 77030
Forest Investigative Site 332 Recruiting
Huntsville, Texas, United States, 77340
Forest Investigative Site 107 Withdrawn
Killeen, Texas, United States, 76543
Forest Investigative Site 232 Completed
Longview, Texas, United States, 75605
Forest Investigative Site 145 Completed
San Antonio, Texas, United States, 78218
Forest Investigative Site 049 Terminated
Tyler, Texas, United States, 75708
United States, Vermont
Forest Investigative Site 181 Recruiting
Colchester, Vermont, United States, 05446
United States, Virginia
Forest Investigative Site 125 Recruiting
Abingdon, Virginia, United States, 24210
Forest Investigative Site 045 Terminated
Richmond, Virginia, United States, 23233
Forest Investigative Site 202 Recruiting
Richmond, Virginia, United States, 23225
Forest Investigative Site 231 Recruiting
Richmond, Virginia, United States, 23229
United States, Washington
Forest Investigative Site 113 Withdrawn
Spokane, Washington, United States, 99201
Forest Investigative Site 174 Recruiting
Spokane, Washington, United States, 99204
Forest Investigative Site 184 Recruiting
Spokane, Washington, United States, 99202
Forest Investigative Site 217 Recruiting
Tacoma, Washington, United States, 98405
United States, West Virginia
Forest Investigative Site 335 Recruiting
Charleston, West Virginia, United States, 25304
Forest Investigative Site 319 Recruiting
Morgantown, West Virginia, United States, 26505
United States, Wisconsin
Forest Investigative Site 146 Recruiting
West Allis, Wisconsin, United States, 53227
Argentina
Forest Investigative Site 418 Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425DES
Forest Investigative Site 402 Recruiting
Florida, Buenos Aires, Argentina, B1602DOH
Forest Investigative Site 405 Completed
La Plata, Buenos Aires, Argentina, 1900
Forest Investigative Site 413 Recruiting
Mar del Plata, Buenos Aires, Argentina, CP 7600
Forest Investigative Site 407 Completed
Parana, Entre Rios, Argentina, E3100BHK
Forest Investigative Site 406 Recruiting
Lanús Este, Provincia de Buenos Aires, Argentina, B1824 KAJ
Forest Investigative Site 412 Recruiting
Rosario, Santa Fe, Argentina, S2000DBS
Forest Investigative Site 409 Recruiting
Rosario, Santa Fe, Argentina, S2000KZD
Forest Investigative Site 403 Completed
Buenos Aires, Argentina, B1842DID
Forest Investigative Site 414 Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1122AAK
Forest Investigative Site 411 Completed
Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO
Forest Investigative Site 419 Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1426ABP
Forest Investigative Site 416 Recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1428DDE
Forest Investigative Site 415 Recruiting
Derqui Pilar - Buenos Aires, Argentina, B1629ODT
Forest Investigative Site 410 Recruiting
Florencio Varela, Argentina, 1888
Forest Investigative Site 417 Completed
La Plata, Argentina, 1900
Forest Investigative Site 420 Recruiting
Mendoza, Argentina, 5500
Forest Investigative Site 404 Recruiting
Mendoza, Argentina, M5500CCG
Forest Investigative Site 401 Recruiting
San Miguel de Tucuman, Argentina, T4000IFL
Forest Investigative Site 408 Recruiting
Santa Fe, Argentina, 3000
Canada, Alberta
Forest Investigative Site 235 Recruiting
Calgary, Alberta, Canada, T2K5R7
Forest Investigative Site 260 Withdrawn
Edmonton, Alberta, Canada, T5J3S9
Canada, British Columbia
Forest Investigative Site 162 Active, not recruiting
North Vancouver, British Columbia, Canada, V7M 2H9
Forest Investigative Site 182 Withdrawn
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Nova Scotia
Forest Investigative Site 171 Withdrawn
Halifax, Nova Scotia, Canada, B3H 2A7
Forest Investigative Site 249 Completed
Truro, Nova Scotia, Canada, B2N1L2
Canada, Ontario
Forest Investigative Site 302 Recruiting
Burlington, Ontario, Canada, L7N 3V2
Forest Investigative Site 210 Withdrawn
Hamilton, Ontario, Canada, L8N 486
Canada, Quebec
Forest Investigative Site 185 Recruiting
Montreal, Quebec, Canada, H2R 1V6
Canada, Saskatchewan
Forest Investigative Site 127 Recruiting
Saskatoon, Saskatchewan, Canada, S7N0W8
Chile
Forest Investigative Site 432 Completed
Santiago, Chile, 7500710
Forest Investigative Site 422 Not yet recruiting
Santiago, Chile, 7500710
Forest Investigative Site 430 Completed
Talcahuano, Chile, 4270918
Forest Investigative Site 421 Recruiting
Talcahuano, Chile, 4270918
Forest Investigative Site 431 Completed
Temuco, Chile, 4800798
Colombia
Forest Investigative Site 442 Recruiting
Bogota, Colombia, 111111
Forest Investigative Site 443 Recruiting
Bogota, Colombia, 111711
Forest Investigative Site 444 Completed
Bogota, Colombia, 110111
Forest Investigative Site 441 Not yet recruiting
Cali, Colombia, 760032
Italy
Forest Investigative Site 461 Recruiting
Chieti, Italy, 66013
Forest Investigative Site 465 Not yet recruiting
Pavia, Italy, 27100
Forest Investigative Site 463 Not yet recruiting
Roma, Italy, 161
Forest Investigative Site 464 Recruiting
Roma, Italy, 00168
Forest Investigative Site 462 Completed
Verona, Italy, 37124
Latvia
Forest Investigative Site 481 Not yet recruiting
Riga, Latvia, LV-1038
Malaysia
Forest Investigative Site 505 Recruiting
Batu Caves, Malaysia, 68100
Forest Investigative Site 501 Recruiting
Kuala Lumpur, Malaysia, 50588
Forest Investigative Site 504 Recruiting
Kuala Lumpur, Malaysia, 59100
Forest Investigative Site 503 Completed
Kuala Terengganu, Malaysia, 20400
Forest Investigative Site 502 Recruiting
Kuantan, Malaysia, 25100
Mexico
Forest Investigative Site 522 Recruiting
Monterrey, Nuevo León, Mexico, 64460
Forest Investigative Site 526 Recruiting
Merida, Yucatan, Mexico, 97070
Forest Investigative Site 523 Recruiting
Durango, Mexico, 34270
Forest Investigative Site 524 Recruiting
Guadalajara, Mexico, 44100
Forest Investigative Site 521 Recruiting
Monterrey, Mexico, 64060
Peru
Forest Investigative Site 542 Completed
Lima, San Juan de Miraflores, Peru, Lima 29
Forest Investigative Site 543 Recruiting
Bellavista, Peru, Callao 2
Forest Investigative Site 547 Not yet recruiting
Callao, Peru, Callao 2
Forest Investigative Site 544 Recruiting
Lima, Peru, Lima 33
Forest Investigative Site 550 Recruiting
Lima, Peru, Lima 11
Forest Investigative Site 546 Recruiting
Lima, Peru, Lima 27
Forest Investigative Site 549 Recruiting
Lima, Peru, Lima 31
Forest Investigative Site 545 Recruiting
Lima, Peru, Lima 18
Forest Investigative Site 551 Recruiting
Lima, Peru, Lima 13
Forest Investigative Site 541 Recruiting
Pueblo Libre, Peru, Lima 21
Forest Investigative Site 548 Not yet recruiting
San Isidro, Peru, Lima 27
Philippines
Forest Investigative Site 569 Recruiting
Cavite, Philippines, 4114
Forest Investigative Site 567 Recruiting
Iloilo City, Philippines, 5000
Forest Investigative Site 568 Recruiting
Iloilo City, Philippines, 5000
Forest Investigative Site 565 Recruiting
Manila, Philippines, 1000
Forest Investigative Site 563 Recruiting
Pasig City, Philippines, 1600
Forest Investigative Site 561 Recruiting
Quezon City, Philippines, 1118
Forest Investigative Site 566 Recruiting
Quezon City, Philippines, 1109
Forest Investigative Site 562 Recruiting
Quezon City, Philippines, 1100
Forest Investigative Site 564 Recruiting
Quezon City, Philippines, 1100
Romania
Forest Investigative Site 585 Recruiting
Brasov, Romania, 500112
Forest Investigative Site 582 Recruiting
Bucharest, Romania, 50554
Forest Investigative Site 584 Completed
Bucharest, Romania, 50159
Forest Investigative Site 586 Recruiting
Bucharest, Romania, 10457
Forest Investigative Site 587 Recruiting
Bucharest, Romania, 30303
Forest Investigative Site 588 Recruiting
Bucharest, Romania, 31298
Forest Investigative Site 581 Recruiting
Iasi, Romania, 700115
Forest Investigative Site 583 Recruiting
Iasi, Romania, 700115
Russian Federation
Forest Investigative Site 608 Not yet recruiting
Barnaul, Russian Federation, 656045
Forest Investigative Site 602 Not yet recruiting
Kazan, Russian Federation, 420015
Forest Investigative Site 609 Not yet recruiting
Krasnodar, Russian Federation, 350012
Forest Investigative Site 605 Not yet recruiting
Novosibirsk, Russian Federation, 630099
Forest Investigative Site 603 Terminated
Shakhty, Russian Federation, 346510
Forest Investigative Site 600 Not yet recruiting
St Petersburg, Russian Federation, 197706
Forest Investigative Site 601 Not yet recruiting
St. Petersburg, Russian Federation, 197110
Forest Investigative Site 604 Not yet recruiting
St. Petersburg, Russian Federation, 194358
Forest Investigative Site 610 Not yet recruiting
St. Petersburg, Russian Federation, 196247
Forest Investigative Site 611 Not yet recruiting
St. Petersburg, Russian Federation, 196084
Forest Investigative Site 612* Not yet recruiting
St. Petersburg, Russian Federation, 193231
Forest Investigative Site 606 Not yet recruiting
St.Petersburg, Russian Federation, 191025
Forest Investigative Site 607 Not yet recruiting
Tomsk, Russian Federation, 634063
Serbia
Forest Investigative Site 622 Recruiting
Belgrade, Serbia, 11000
Forest Investigative Site 623 Recruiting
Belgrade, Serbia, 11000
Forest Investigative Site 624 Recruiting
Belgrade, Serbia, 11000
Forest Investigative Site 625 Recruiting
Beograd, Serbia, 11000
Forest Investigative Site 626 Not yet recruiting
Beograd, Serbia, 11129
Forest Investigative Site 628 Recruiting
Kragujevac, Serbia, 34000
Forest Investigative Site 627 Recruiting
Sremska Kamenica, Serbia, 21204
Spain
Forest Investigative Site 642 Withdrawn
Aranjuez, Spain, 28300
Forest Investigative Site 643 Completed
Badalona, Spain, 8916
Forest Investigative Site 641 Recruiting
Cadiz, Spain, 11009
Forest Investigative Site 649 Completed
Jaen, Spain, 23007
Forest Investigative Site 647 Recruiting
Loja, Spain, 18300
Forest Investigative Site 646 Completed
Madrid, Spain, 28041
Forest Investigative Site 648 Completed
Madrid, Spain, 28040
Forest Investigative Site 644 Recruiting
Salt, Spain, 17190
Forest Investigative Site 645 Not yet recruiting
Santiago de Compostela, Spain, 15706
Taiwan
Forest Investigative Site 723 Recruiting
Kaohsiung Hsien, Taiwan, 833
Forest Investigative Site 724 Recruiting
Puzih City, Taiwan, 61363
Forest Investigative Site 722 Recruiting
Taipei, Taiwan, 11490
Forest Investigative Site 725 Recruiting
Taipei, Taiwan, 100
Thailand
Forest Investigative Site 662 Recruiting
Hat Yai, Songkhla, Thailand, 90110
Forest Investigative Site 663 Recruiting
Bangkok, Thailand, 11000
Forest Investigative Site 664 Recruiting
Bangkok, Thailand, 10400
Forest Investigative Site 661 Recruiting
Muang, Thailand, 40002
Ukraine
Forest Investigative Site 699 Recruiting
Cherkasy, Ukraine, 18009
Forest Investigative Site 691 Recruiting
Dnipropetrovsk, Ukraine, 49074
Forest Investigative Site 704 Not yet recruiting
Donetsk, Ukraine, 83059
Forest Investigative Site 692 Recruiting
Donetsk, Ukraine, 83003
Forest Investigative Site 689 Recruiting
Donetsk, Ukraine, 83099
Forest Investigative Site 690 Recruiting
Ivano-Frankivsk, Ukraine, 76018
Forest Investigative Site 693 Recruiting
Kharkiv, Ukraine, 61039
Forest Investigative Site 697 Recruiting
Kharkiv, Ukraine, 61035
Forest Investigative Site 682 Recruiting
Kharkiv, Ukraine, 61124
Forest Investigative Site 709 Recruiting
Kremenchuk, Ukraine
Forest Investigative Site 685 Recruiting
Kyiv, Ukraine, 4050
Forest Investigative Site 687 Recruiting
Kyiv, Ukraine, 3680
Forest Investigative Site 683 Recruiting
Kyiv, Ukraine, 3680
Forest Investigative Site 698 Recruiting
Kyiv, Ukraine, 3049
Forest Investigative Site 684 Recruiting
Kyiv, Ukraine, 3680
Forest Investigative Site 681 Recruiting
Lviv, Ukraine, 79013
Forest Investigative Site 708 Recruiting
Mykolayiv, Ukraine, 54003
Forest Investigative Site 706 Recruiting
Poltava, Ukraine, 36038
Forest Investigative Site 695 Recruiting
Sumy, Ukraine, 40000
Forest Investigative Site 686 Recruiting
Ternopil, Ukraine, 46000
Forest Investigative Site 707 Recruiting
Vinnitsa, Ukraine, 21001
Forest Investigative Site 688 Recruiting
Zaporizhzhia, Ukraine, 69600
Forest Investigative Site 696 Recruiting
Zaporizhzhya, Ukraine, 69035
Forest Investigative Site 694 Recruiting
Zaporizhzhya, Ukraine, 69106
Forest Investigative Site 705 Recruiting
Zaporizhzhya, Ukraine, 69118
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Nazim Khan, MD Forest Laboratories
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT01443845     History of Changes
Other Study ID Numbers: ROF-MD-07
Study First Received: September 28, 2011
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Latvia: State Agency of Medicines
Malaysia: Ministry of Health
Mexico: Secretaria de Salud
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Peru: Instituto Nacional de Salud
Philippines: Bureau of Food and Drugs
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Taiwan : Food and Drug Administration
Thailand: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Forest Laboratories:
COPD
Exacerbations
Roflumilast
Daliresp

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on July 26, 2014