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.
Verified September 2013 by Forest Laboratories
Sponsor:
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT01443845
First received: September 28, 2011
Last updated: September 30, 2013
Last verified: September 2013
  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: June 2015
Estimated Primary Completion Date: May 2015 (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
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 Recruiting
Anniston, Alabama, United States, 36207
Forest Investigative Site 065 Recruiting
Athens, Alabama, United States, 35611
Forest Investigative Site 031 Recruiting
Birmingham, Alabama, United States, 35209
Forest Investigative Site 039 Recruiting
Birmingham, Alabama, United States, 35216
Forest Investigative Site 131 Withdrawn
Florence, Alabama, United States, 35630
Forest Investigative Site 225 Withdrawn
Gulf Shores, Alabama, United States, 36542
Forest Investigative Site 073 Recruiting
Mobile, Alabama, United States, 36608
United States, Arizona
Forest Investigative Site 311 Recruiting
Glendale, Arizona, United States, 85306
Forest Investigative Site 272 Recruiting
Mesa, Arizona, United States, 85206
Forest Investigative Site 091 Recruiting
Peoria, Arizona, United States, 85381
Forest Investigative Site 211 Recruiting
Phoenix, Arizona, United States, 85028
Forest Investigative Site 188 Recruiting
Phoenix, Arizona, United States, 85020
Forest Investigative Site 170 Withdrawn
Phoenix, Arizona, United States, 85008
Forest Investigative Site 034 Recruiting
Phoenix, Arizona, United States, 85018
Forest Investigative Site 298 Withdrawn
Phoenix, Arizona, United States, 85012
Forest Investigative Site 247 Recruiting
Phoenix, Arizona, United States, 85050
Forest Investigative Site 266 Withdrawn
Phoenix, Arizona, United States, 85020
United States, Arkansas
Forest Investigative Site 208 Recruiting
Fort Smith, Arkansas, United States, 72901
Forest Investigative Site 101 Recruiting
Little Rock, Arkansas, United States, 72205
Forest Investigative Site 222 Withdrawn
Searcy, Arkansas, United States, 72143
United States, California
Forest Investigative Site 159 Withdrawn
Anaheim, California, United States, 92801
Forest Investigative Site 074 Recruiting
Bellflower, California, United States, 90706
Forest Investigative Site 048 Withdrawn
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 Recruiting
Fullerton, California, United States, 92835
Forest Investigative Site 310 Recruiting
Garden Grove, California, United States, 92844
Forest Investigative Site 057 Withdrawn
La Jolla, California, United States, 92093
Forest Investigative Site 297 Recruiting
Lakewood, California, United States, 90712
Forest Investigative Site 126 Not yet recruiting
Loma Linda, California, United States, 92357
Forest Investigative Site 116 Recruiting
Long Beach, California, United States, 90822
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 244 Withdrawn
Los Angeles, California, United States, 90095
Forest Investigative Site 279 Recruiting
Los Angeles, California, United States, 90033
Forest Investigative Site 299 Recruiting
Northridge, California, United States, 91325
Forest Investigative Site 274 Withdrawn
Palm Springs, California, United States, 92262
Forest Investigative Site 320 Withdrawn
Palmdale, California, United States, 93551
Forest Investigative Site 213 Recruiting
Palo Alto, California, United States, 94555
Forest Investigative Site 016 Withdrawn
Paramount, California, United States, 90723
Forest Investigative Site 268 Recruiting
Pismo Beach, California, United States, 93449
Forest Investigative Site 183 Not yet recruiting
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 080 Withdrawn
San Jose, California, United States, 95116
Forest Investigative Site 326 Recruiting
San Jose, California, United States, 95124
Forest Investigative Site 209 Recruiting
Torrance, California, United States, 90502
United States, Colorado
Forest Investigative Site 203 Withdrawn
Arvada, Colorado, United States, 80005
Forest Investigative Site 037 Withdrawn
Boulder, Colorado, United States, 80304
Forest Investigative Site 242 Withdrawn
Colorado Springs, Colorado, United States, 80906
Forest Investigative Site 089 Not yet recruiting
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 Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Forest Investigative Site 114 Withdrawn
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 166 Recruiting
Chiefland, Florida, United States, 32626
Forest Investigative Site 111 Recruiting
Clearwater, Florida, United States, 33756
Forest Investigative Site 123 Withdrawn
Clearwater, Florida, United States, 33765
Forest Investigative Site 192 Withdrawn
Coral Gables, Florida, United States, 33134
Forest Investigative Site 291 Recruiting
Coral Gables, Florida, United States, 33134
Forest Investigative Site 296 Withdrawn
Debary, Florida, United States, 32713
Forest Investigative Site 239 Recruiting
DeFuniak Springs, Florida, United States, 32435
Forest Investigative Site 001 Recruiting
Fort Lauderdale, Florida, United States, 33316
Forest Investigative Site 165 Recruiting
Fort Walton Beach, Florida, United States, 32547
Forest Investigative Site 102 Recruiting
Gainesville, Florida, United States, 32608
Forest Investigative Site 194 Withdrawn
Gainsville, Florida, United States, 32611
Forest Investigative Site 003 Recruiting
Hollywood, Florida, United States, 33024
Forest Investigative Site 023 Recruiting
Jacksonville, Florida, United States, 32216
Forest Investigative Site 077 Recruiting
Kissimmee, Florida, United States, 34741
Forest Investigative Site 330 Recruiting
Kissimmee, Florida, United States, 34741
Forest Investigative Site 190 Withdrawn
Miami, Florida, United States, 33144
Forest Investigative Site 153 Withdrawn
Miami, Florida, United States, 33186
Forest Investigative Site 027 Terminated
Miami, Florida, United States, 33015
Forest Investigative Site 229 Recruiting
Miami, Florida, United States, 33136
Forest Investigative Site 115 Recruiting
Miami, Florida, United States, 33175
Forest Investigative Site 254 Withdrawn
Miami, Florida, United States, 33185
Forest Investigative Site 339 Recruiting
Miami, Florida, United States, 33186
Forest Investigative Site 234 Withdrawn
Miami Springs, Florida, United States, 33166
Forest Investigative Site 018 Not yet recruiting
Miramar, Florida, United States, 33025
Forest Investigative Site 092 Recruiting
Naples, Florida, United States, 34119
Forest Investigative Site 026 Withdrawn
North Miami Beach, Florida, United States, 33179
Forest Investigative Site 191 Withdrawn
Orlando, Florida, United States, 32803
Forest Investigative Site 004 Recruiting
Orlando, Florida, United States, 32822
Forest Investigative Site 187 Recruiting
Ormond Beach, Florida, United States, 32174
Forest Investigative Site 309 Withdrawn
Pembroke Pines, Florida, United States, 33024
Forest Investigative Site 284 Withdrawn
Pembroke Pines, Florida, United States, 33029
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 109 Withdrawn
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 287 Recruiting
Tampa, Florida, United States, 33607
Forest Investigative Site 007 Withdrawn
Tampa, Florida, United States, 33603
Forest Investigative Site 052 Recruiting
Tampa, Florida, United States, 33613
Forest Investigative Site 295 Withdrawn
Venice, Florida, United States, 34292
Forest Investigative Site 011 Recruiting
Winter Park, Florida, United States, 32789
Forest Investigative Site 096 Recruiting
Zephyrhills, Florida, United States, 33542
United States, Georgia
Forest Investigative Site 151 Withdrawn
Atlanta, Georgia, United States, 30329
Forest Investigative Site 216 Recruiting
Atlanta, Georgia, United States, 30342
Forest Investigative Site 240 Withdrawn
Atlanta, Georgia, United States, 30342
Forest Investigative Site 041 Withdrawn
Austell, Georgia, United States, 30106
Forest Investigative Site 103 Recruiting
Canton, Georgia, United States, 30114
Forest Investigative Site 292 Terminated
Dawsonville, Georgia, United States, 30534
Forest Investigative Site 276 Withdrawn
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 Recruiting
Woodstock, Georgia, United States, 30189
United States, Hawaii
Forest Investigative Site 178 Withdrawn
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 Withdrawn
Elk Grove Village, Illinois, United States, 60007
Forest Investigative Site 014 Withdrawn
Maywood, Illinois, United States, 60153
Forest Investigative Site 200 Withdrawn
Normal, Illinois, United States, 61761
Forest Investigative Site 173 Withdrawn
O'Fallon, Illinois, United States, 62269
Forest Investigative Site 139 Withdrawn
Oak Lawn, Illinois, United States, 60453
Forest Investigative Site 246 Withdrawn
Oak Park, Illinois, United States, 60302
Forest Investigative Site 227 Recruiting
Peoria, Illinois, United States, 61637
Forest Investigative Site 141 Withdrawn
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 Recruiting
Michigan City, Indiana, United States, 46360
Forest Investigative Site 264 Recruiting
Muncie, Indiana, United States, 47303
Forest Investigative Site 043 Withdrawn
South Bend, Indiana, United States, 46617
United States, Iowa
Forest Investigative Site 135 Recruiting
Council Bluffs, Iowa, United States, 51503
Forest Investigative Site 255 Withdrawn
Iowa City, Iowa, United States, 52240
Forest Investigative Site 256 Recruiting
Iowa City, Iowa, United States, 52242
United States, Kansas
Forest Investigative Site 163 Withdrawn
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 Recruiting
Wichita, Kansas, United States, 67205
United States, Kentucky
Forest Investigative Site 051 Recruiting
Bowling Green, Kentucky, United States, 42101
Forest Investigative Site 075 Recruiting
Crescent Springs, Kentucky, United States, 41017
Forest Investigative Site 068 Withdrawn
Lexington, Kentucky, United States, 40504
Forest Investigative Site 275 Not yet recruiting
Lexington, Kentucky, United States, 40536
Forest Investigative Site 088 Recruiting
Louisville, Kentucky, United States, 40215
Forest Investigative Site 207 Recruiting
Louisville, Kentucky, United States, 40217
Forest Investigative Site 053 Withdrawn
Owensboro, Kentucky, United States, 42303
Forest Investigative Site 152 Recruiting
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 Recruiting
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
United States, Michigan
Forest Investigative Site 157 Recruiting
Ann Arbor, Michigan, United States, 48106
Forest Investigative Site 099 Withdrawn
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 Withdrawn
Pinconning, Michigan, United States, 48605
Forest Investigative Site 322 Recruiting
Saint Joseph, Michigan, United States, 49085
Forest Investigative Site 035 Withdrawn
Stevensville, Michigan, United States, 49127
United States, Minnesota
Forest Investigative Site 303 Recruiting
Edina, Minnesota, United States, 55435
Forest Investigative Site 056 Recruiting
Fridley, Minnesota, United States, 55432
Forest Investigative Site 198 Withdrawn
Minneapolis, Minnesota, United States, 55402
Forest Investigative Site 212 Withdrawn
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 Withdrawn
Jefferson City, Missouri, United States, 65109
Forest Investigative Site 117 Recruiting
Springfield, Missouri, United States, 65803
Forest Investigative Site 098 Recruiting
St. Charles, Missouri, United States, 63301
Forest Investigative Site 084 Withdrawn
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 046 Withdrawn
Fremont, Nebraska, United States, 68025
Forest Investigative Site 267 Recruiting
Fremont, Nebraska, United States, 68025
Forest Investigative Site 337 Recruiting
Fremont, Nebraska, United States, 68028
Forest Investigative Site 108 Recruiting
Lincoln, Nebraska, United States, 68510
Forest Investigative Site 315 Recruiting
Lincoln, Nebraska, United States, 68506
Forest Investigative Site 290 Withdrawn
Lincoln, Nebraska, United States, 68521
Forest Investigative Site 022 Withdrawn
Omaha, Nebraska, United States, 68114
United States, Nevada
Forest Investigative Site 079 Recruiting
Henderson, Nevada, United States, 89014
Forest Investigative Site 270 Recruiting
Henderson, Nevada, United States, 89052
Forest Investigative Site 251 Not yet recruiting
Las Vegas, Nevada, United States, 89102
Forest Investigative Site 252 Withdrawn
Las Vegas, Nevada, United States, 89119
United States, New Hampshire
Forest Investigative Site 138 Recruiting
Newington, New Hampshire, United States, 03801
United States, New Jersey
Forest Investigative Site 067 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 Withdrawn
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 Withdrawn
Albuquerque, New Mexico, United States, 87106
Forest Investigative Site 076 Recruiting
Albuquerque, New Mexico, United States, 87108
United States, New York
Forest Investigative Site 133 Not yet recruiting
Brooklyn, New York, United States, 11234
Forest Investigative Site 226 Recruiting
Brooklyn, New York, United States, 11229
Forest Investigative Site 286 Recruiting
Corning, New York, United States, 14830
Forest Investigative Site 169 Not yet recruiting
Glens Falls, New York, United States, 12801
Forest Investigative Site 199 Recruiting
Great Neck, New York, United States, 11021
Forest Investigative Site 047 Not yet recruiting
New York, New York, United States, 100003
Forest Investigative Site 071 Recruiting
New York, New York, United States, 10029
Forest Investigative Site 083 Not yet recruiting
New York, New York, United States, 10016
Forest Investigative Site 013 Recruiting
Rochester, New York, United States, 14618
Forest Investigative Site 066 Recruiting
Syracuse, New York, United States, 13210
Forest Investigative Site 158 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 Withdrawn
Calabash, North Carolina, United States, 28467
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 219 Terminated
Charlotte, North Carolina, United States, 28210
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 Withdrawn
Hickory, North Carolina, United States, 28602
Forest Investigative Site 269 Not yet recruiting
Huntersville, North Carolina, United States, 28078
Forest Investigative Site 318 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 258 Recruiting
Winston Salem, North Carolina, United States, 28277
Forest Investigative Site 314 Recruiting
Winston Salem, North Carolina, United States, 27103
Forest Investigative Site 189 Withdrawn
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 Recruiting
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 280 Recruiting
Cincinnati, Ohio, United States, 45267
Forest Investigative Site 149 Recruiting
Cincinnati, Ohio, United States, 45219
Forest Investigative Site 040 Recruiting
Cincinnati, Ohio, United States, 45242
Forest Investigative Site 095 Not yet recruiting
Cleveland, Ohio, United States, 44106
Forest Investigative Site 009 Recruiting
Columbus, Ohio, United States, 43213
Forest Investigative Site 059 Recruiting
Marion, Ohio, United States, 43302
Forest Investigative Site 154 Withdrawn
Marion, Ohio, United States, 43302
Forest Investigative Site 105 Withdrawn
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Forest Investigative Site 167 Withdrawn
Oklahoma City, Oklahoma, United States, 73103
Forest Investigative Site 281 Recruiting
Oklahoma City, Oklahoma, United States, 73103
Forest Investigative Site 236 Withdrawn
Tulsa, Oklahoma, United States, 74135
Forest Investigative Site 323 Withdrawn
Tulsa, Oklahoma, United States, 74127
United States, Oregon
Forest Investigative Site 112 Withdrawn
Corvallis, Oregon, United States, 97330
Forest Investigative Site 304 Withdrawn
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 Withdrawn
Allentown, Pennsylvania, United States, 18103
Forest Investigative Site 086 Recruiting
Altoona, Pennsylvania, United States, 16601
Forest Investigative Site 132 Withdrawn
Altoona, Pennsylvania, United States, 16602
Forest Investigative Site 130 Withdrawn
Beaver, Pennsylvania, United States, 15009
Forest Investigative Site 340 Recruiting
Beaver, Pennsylvania, United States, 15009
Forest Investigative Site 155 Withdrawn
Belle Vernon, Pennsylvania, United States, 15012
Forest Investigative Site 036 Recruiting
Belle Vernon, Pennsylvania, United States, 15012
Forest Investigative Site 179 Withdrawn
Clairton, Pennsylvania, United States, 15025
Forest Investigative Site 120 Recruiting
Downingtown, Pennsylvania, United States, 19335
Forest Investigative Site 062 Recruiting
Erie, Pennsylvania, United States, 16506
Forest Investigative Site 006 Withdrawn
Hershey, Pennsylvania, United States, 17033
Forest Investigative Site 265 Withdrawn
Ingomar, Pennsylvania, United States, 15127
Forest Investigative Site 147 Withdrawn
Langhorne, Pennsylvania, United States, 19047
Forest Investigative Site 277 Recruiting
Norristown, Pennsylvania, United States, 19401
Forest Investigative Site 137 Withdrawn
Philadelphia, Pennsylvania, United States, 19104
Forest Investigative Site 205 Recruiting
Philadelphia, Pennsylvania, United States, 19140
Forest Investigative Site 230 Recruiting
Philadelphia, Pennsylvania, United States, 19107
Forest Investigative Site 250 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19138
Forest Investigative Site 118 Withdrawn
Phoenixville, Pennsylvania, United States, 19460
Forest Investigative Site 336 Recruiting
Pittsburgh, Pennsylvania, United States, 15221
Forest Investigative Site 028 Withdrawn
Scottdale, Pennsylvania, United States, 15683
Forest Investigative Site 308 Withdrawn
Shippensburg, Pennsylvania, United States, 17257
Forest Investigative Site 010 Recruiting
Tipton, Pennsylvania, United States, 16684
Forest Investigative Site 064 Recruiting
Uniontown, Pennsylvania, United States, 15401
Forest Investigative Site 294 Withdrawn
Yardley, Pennsylvania, United States, 19067
United States, Rhode Island
Forest Investigative Site 129 Withdrawn
Cumberland, Rhode Island, United States, 02864
Forest Investigative Site 055 Withdrawn
East Providence, Rhode Island, United States, 02914
Forest Investigative Site 228 Recruiting
Johnston, Rhode Island, United States, 02919
Forest Investigative Site 283 Withdrawn
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Forest Investigative Site 015 Withdrawn
Charleston, South Carolina, United States, 29412
Forest Investigative Site 100 Withdrawn
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 Recruiting
Fort Mill, South Carolina, United States, 29707
Forest Investigative Site 233 Recruiting
Gaffney, South Carolina, United States, 29340
Forest Investigative Site 110 Withdrawn
Greenville, South Carolina, United States, 29615
Forest Investigative Site 243 Withdrawn
Greenville, South Carolina, United States, 29607
Forest Investigative Site 300 Recruiting
Pelzer, South Carolina, United States, 29669
Forest Investigative Site 204 Recruiting
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 Withdrawn
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 195 Recruiting
Houston, Texas, United States, 77034
Forest Investigative Site 237 Withdrawn
Houston, Texas, United States, 77030
Forest Investigative Site 261 Withdrawn
Houston, Texas, United States, 77030
Forest Investigative Site 271 Not yet recruiting
Houston, Texas, United States, 77030
Forest Investigative Site 312 Recruiting
Houston, Texas, United States, 77079
Forest Investigative Site 332 Recruiting
Huntsville, Texas, United States, 77340
Forest Investigative Site 107 Withdrawn
Killeen, Texas, United States, 76543
Forest Investigative Site 232 Recruiting
Longview, Texas, United States, 75605
Forest Investigative Site 145 Withdrawn
San Antonio, Texas, United States, 78218
Forest Investigative Site 049 Recruiting
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 231 Recruiting
Richmond, Virginia, United States, 23229
Forest Investigative Site 202 Recruiting
Richmond, Virginia, United States, 23225
Forest Investigative Site 045 Withdrawn
Richmond, Virginia, United States, 23233
United States, Washington
Forest Investigative Site 113 Not yet recruiting
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 402 Not yet recruiting
Florida, Buenos Aires, Argentina, B1602DOH
Forest Investigative Site 405 Not yet recruiting
La Plata, Buenos Aires, Argentina, 1900
Forest Investigative Site 413 Not yet recruiting
Mar del Plata, Buenos Aires, Argentina, CP 7600
Forest Investigative Site 407 Not yet recruiting
Parana, Entre Rios, Argentina, E3100BHK
Forest Investigative Site 406 Not yet recruiting
Lanús Este, Provincia de Buenos Aires, Argentina, B1824 KAJ
Forest Investigative Site 409 Not yet recruiting
Rosario, Santa Fe, Argentina, S2000KZD
Forest Investigative Site 412 Not yet recruiting
Rosario, Santa Fe, Argentina, S2000DBS
Forest Investigative Site 403 Not yet recruiting
Buenos Aires, Argentina, B1842DID
Forest Investigative Site 411 Not yet recruiting
Ciudad Autonoma de Buenos Aires, Argentina, C1015ABO
Forest Investigative Site 410 Not yet recruiting
Florencio Varela, Argentina, 1888
Forest Investigative Site 404 Not yet recruiting
Mendoza, Argentina, M5500CCG
Forest Investigative Site 401 Not yet recruiting
San Miguel de Tucuman, Argentina, T4000IFL
Forest Investigative Site 408 Not yet recruiting
Santa Fe, Argentina, 3000
Canada, Alberta
Forest Investigative Site 235 Recruiting
Calgary, Alberta, Canada, T2K5R7
Forest Investigative Site 260 Not yet recruiting
Edmonton, Alberta, Canada, T5J3S9
Canada, British Columbia
Forest Investigative Site 162 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 Withdrawn
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 422 Not yet recruiting
Santiago, Chile, 7500710
Forest Investigative Site 421 Not yet recruiting
Talcahuano, Chile, 4270918
Colombia
Forest Investigative Site 442 Not yet recruiting
Bogota, Colombia, 111111
Forest Investigative Site 443 Not yet recruiting
Bogota, Colombia, 111711
Forest Investigative Site 444 Not yet recruiting
Bogota, Colombia, 110111
Forest Investigative Site 441 Not yet recruiting
Cali, Colombia, 760032
Italy
Forest Investigative Site 461 Not yet 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 Not yet recruiting
Roma, Italy, 00168
Forest Investigative Site 462 Not yet recruiting
Verona, Italy, 37124
Latvia
Forest Investigative Site 481 Not yet recruiting
Riga, Latvia, LV-1038
Malaysia
Forest Investigative Site 505 Not yet recruiting
Batu Caves, Malaysia, 68100
Forest Investigative Site 501 Not yet recruiting
Kuala Lumpur, Malaysia, 50588
Forest Investigative Site 504 Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Forest Investigative Site 503 Not yet recruiting
Kuala Terengganu, Malaysia, 20400
Forest Investigative Site 502 Not yet recruiting
Kuantan, Malaysia, 25100
Mexico
Forest Investigative Site 522 Not yet recruiting
Monterrey, Nuevo León, Mexico, 64460
Forest Investigative Site 523 Not yet recruiting
Durango, Mexico, 34270
Forest Investigative Site 521 Not yet recruiting
Monterrey, Mexico, 64060
Peru
Forest Investigative Site 542 Not yet recruiting
Lima, San Juan de Miraflores, Peru, Lima 29
Forest Investigative Site 543 Not yet recruiting
Bellavista, Peru, Callao 2
Forest Investigative Site 547 Not yet recruiting
Callao, Peru, Callao 2
Forest Investigative Site 545 Not yet recruiting
Lima, Peru, Lima 18
Forest Investigative Site 550 Not yet recruiting
Lima, Peru, Lima 11
Forest Investigative Site 549 Not yet recruiting
Lima, Peru, Lima 31
Forest Investigative Site 546 Not yet recruiting
Lima, Peru, Lima 27
Forest Investigative Site 544 Not yet recruiting
Lima, Peru, Lima 33
Forest Investigative Site 541 Not yet recruiting
Pueblo Libre, Peru, Lima 21
Forest Investigative Site 548 Not yet recruiting
San Isidro, Peru, Lima 27
Philippines
Forest Investigative Site 567 Not yet recruiting
Iloilo City, Philippines, 5000
Forest Investigative Site 565 Not yet recruiting
Manila, Philippines, 1000
Forest Investigative Site 563 Not yet recruiting
Pasig City, Philippines, 1600
Forest Investigative Site 561 Not yet recruiting
Quezon City, Philippines, 1118
Forest Investigative Site 566 Not yet recruiting
Quezon City, Philippines, 1109
Forest Investigative Site 564 Not yet recruiting
Quezon City, Philippines, 1100
Forest Investigative Site 562 Not yet recruiting
Quezon City, Philippines, 1100
Romania
Forest Investigative Site 585 Not yet recruiting
Brasov, Romania, 500112
Forest Investigative Site 582 Not yet recruiting
Bucharest, Romania, 50554
Forest Investigative Site 584 Not yet recruiting
Bucharest, Romania, 50159
Forest Investigative Site 586 Not yet recruiting
Bucharest, Romania, 10457
Forest Investigative Site 587 Not yet recruiting
Bucharest, Romania, 30303
Forest Investigative Site 588 Not yet recruiting
Bucharest, Romania, 31298
Forest Investigative Site 581 Not yet recruiting
Iasi, Romania, 700115
Forest Investigative Site 583 Not yet 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 Not yet recruiting
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 Not yet recruiting
Belgrade, Serbia, 11000
Forest Investigative Site 623 Not yet recruiting
Belgrade, Serbia, 11000
Forest Investigative Site 624 Not yet recruiting
Belgrade, Serbia, 11000
Forest Investigative Site 625 Not yet recruiting
Beograd, Serbia, 11000
Forest Investigative Site 626 Not yet recruiting
Beograd, Serbia, 11129
Forest Investigative Site 628 Not yet recruiting
Kragujevac, Serbia, 34000
Forest Investigative Site 627 Not yet recruiting
Sremska Kamenica, Serbia, 21204
Spain
Forest Investigative Site 642 Not yet recruiting
Aranjuez, Spain, 28300
Forest Investigative Site 643 Not yet recruiting
Badalona, Spain, 8916
Forest Investigative Site 644 Not yet recruiting
Salt, Spain, 17190
Forest Investigative Site 645 Not yet recruiting
Santiago de Compostela, Spain, 15706
Thailand
Forest Investigative Site 662 Not yet recruiting
Hat Yai, Songkhla, Thailand, 90110
Forest Investigative Site 663 Not yet recruiting
Bangkok, Thailand, 11000
Forest Investigative Site 661 Not yet recruiting
Muang, Thailand, 40002
Ukraine
Forest Investigative Site 691 Not yet recruiting
Dnipropetrovsk, Ukraine, 49074
Forest Investigative Site 689 Not yet recruiting
Donetsk, Ukraine, 83099
Forest Investigative Site 690 Not yet recruiting
Ivano-Frankivsk, Ukraine, 76018
Forest Investigative Site 682 Not yet recruiting
Kharkiv, Ukraine, 61124
Forest Investigative Site 683 Not yet recruiting
Kyiv, Ukraine, 3680
Forest Investigative Site 684 Not yet recruiting
Kyiv, Ukraine, 3680
Forest Investigative Site 685 Not yet recruiting
Kyiv, Ukraine, 4050
Forest Investigative Site 687 Not yet recruiting
Kyiv, Ukraine, 3680
Forest Investigative Site 681 Not yet recruiting
Lviv, Ukraine, 79013
Forest Investigative Site 686 Not yet recruiting
Ternopil, Ukraine, 46000
Forest Investigative Site 688 Not yet recruiting
Zaporizhzhia, Ukraine, 69600
Sponsors and Collaborators
Forest Laboratories
Investigators
Study Director: Paul Rowe, 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: September 30, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Latvia: State Agency of Medicines
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Chile: Instituto de Salud Publica de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Mexico: Secretaria de Salud
Peru: Instituto Nacional de Salud
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Philippines: Bureau of Food and Drugs
Taiwan : Food and Drug Administration
Malaysia: Ministry of Health
Thailand: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
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 April 16, 2014