ClinicalTrials.gov record
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
ClinicalTrials.gov ID: NCT01443845
Public ClinicalTrials.gov record NCT01443845. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
Study identification
- NCT ID
- NCT01443845
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 2,354 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2011 (Actual)
- Primary completion
- Nov 30, 2015 (Actual)
- Completion
- Jan 31, 2016 (Actual)
- Last update posted
- Apr 13, 2017
2011 – 2016
United States locations
- U.S. sites
- 217
- U.S. states
- 41
- U.S. cities
- 178
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 081 | Anniston | Alabama | 36207 | — |
| Forest Investigative Site 065 | Athens | Alabama | 35611 | — |
| Forest Investigative Site 131 | Florence | Alabama | 35630 | — |
| Forest Investigative Site 073 | Mobile | Alabama | 36608 | — |
| Forest Investigative Site 272 | Mesa | Arizona | 85206 | — |
| Forest Investigative Site 091 | Peoria | Arizona | 85381 | — |
| Forest Investigative Site 034 | Phoenix | Arizona | 85018 | — |
| Forest Investigative Site 188 | Phoenix | Arizona | 85020 | — |
| Forest Investigative Site 211 | Phoenix | Arizona | 85028 | — |
| Forest Investigative Site 247 | Phoenix | Arizona | 85050 | — |
| Forest Investigative Site 208 | Fort Smith | Arkansas | 72901 | — |
| Forest Investigative Site 101 | Little Rock | Arkansas | 72205 | — |
| Forest Investigative Site 074 | Bellflower | California | 90706 | — |
| Forest Investigative Site 060 | Fresno | California | 93721 | — |
| Forest Investigative Site 329 | Fresno | California | 93726 | — |
| Forest Investigative Site 245 | Fullerton | California | 92835 | — |
| Forest Investigative Site 310 | Garden Grove | California | 92844 | — |
| Forest Investigative Site 297 | Lakewood | California | 90712 | — |
| Forest Investigative Site 116 | Long Beach | California | 90822 | — |
| Forest Investigative Site 085 | Los Angeles | California | 90048 | — |
| Forest Investigative Site 241 | Los Angeles | California | 90073 | — |
| Forest Investigative Site 299 | Northridge | California | 91325 | — |
| Forest Investigative Site 213 | Palo Alto | California | 94555 | — |
| Forest Investigative Site 268 | Pismo Beach | California | 93449 | — |
| Forest Investigative Site 025 | Riverside | California | 92506 | — |
| Forest Investigative Site 143 | Roseville | California | 95661 | — |
| Forest Investigative Site 104 | Sacramento | California | 95817 | — |
| Forest Investigative Site 352 | San Diego | California | 92117 | — |
| Forest Investigative Site 038 | San Diego | California | 92120 | — |
| Forest Investigative Site 326 | San Jose | California | 95124 | — |
| Forest Investigative Site 209 | Torrance | California | 90502 | — |
| Forest Investigative Site 331 | Stamford | Connecticut | 06902 | — |
| Forest Investigative Site 017 | Waterbury | Connecticut | 06708 | — |
| Forest Investigative Site 124 | Newark | Delaware | 19713 | — |
| Forest Investigative Site 196 | Brandon | Florida | 33511 | — |
| Forest Investigative Site 224 | Brandon | Florida | 33511 | — |
| Forest Investigative Site 358 | Brandon | Florida | 33511 | — |
| Forest Investigative Site 166 | Chiefland | Florida | 32626 | — |
| Forest Investigative Site 111 | Clearwater | Florida | 33756 | — |
| Forest Investigative Site 123 | Clearwater | Florida | 33765 | — |
| Forest Investigative Site 291 | Coral Gables | Florida | 33134 | — |
| Forest Investigative Site 239 | DeFuniak Springs | Florida | 32435 | — |
| Forest Investigative Site 001 | Fort Lauderdale | Florida | 33316 | — |
| Forest Investigative Site 165 | Fort Walton Beach | Florida | 32547 | — |
| Forest Investigative Site 102 | Gainesville | Florida | 32608 | — |
| Forest Investigative Site 003 | Hollywood | Florida | 33024 | — |
| Forest Investigative Site 023 | Jacksonville | Florida | 32216 | — |
| Forest Investigative Site 077 | Kissimmee | Florida | 34741 | — |
| Forest Investigative Site 330 | Kissimmee | Florida | 34741 | — |
| Forest Investigative Site 027 | Miami | Florida | 33015 | — |
| Forest Investigative Site 229 | Miami | Florida | 33136 | — |
| Forest Investigative Site 115 | Miami | Florida | 33175 | — |
| Forest Investigative Site 339 | Miami | Florida | 33186 | — |
| Forest Investigative Site 092 | Naples | Florida | 34119 | — |
| Forest Investigative Site 004 | Orlando | Florida | 32822 | — |
| Forest Investigative Site 187 | Ormond Beach | Florida | 32174 | — |
| Forest Investigative Site 069 | Pensacola | Florida | 32504 | — |
| Forest Investigative Site 161 | Ponte Vedra | Florida | 32081 | — |
| Forest Investigative Site 087 | Port Orange | Florida | 32127 | — |
| Forest Investigative Site 109 | Saint Cloud | Florida | 34769 | — |
| Forest Investigative Site 121 | St. Petersburg | Florida | 33704 | — |
| Forest Investigative Site 357 | St. Petersburg | Florida | 33744 | — |
| Forest Investigative Site 002 | Tamarac | Florida | 33312 | — |
| Forest Investigative Site 287 | Tampa | Florida | 33607 | — |
| Forest Investigative Site 052 | Tampa | Florida | 33613 | — |
| Forest Investigative Site 011 | Winter Park | Florida | 32789 | — |
| Forest Investigative Site 348 | Winter Park | Florida | 32792 | — |
| Forest Investigative Site 103 | Canton | Georgia | 30114 | — |
| Forest Investigative Site 292 | Dawsonville | Georgia | 30534 | — |
| Forest Investigative Site 042 | Duluth | Georgia | 30096 | — |
| Forest Investigative Site 140 | Gainesville | Georgia | 30501 | — |
| Forest Investigative Site 030 | Lawrenceville | Georgia | 30046 | — |
| Forest Investigative Site 321 | Woodstock | Georgia | 30189 | — |
| Forest Investigative Site 008 | Coeur d'Alene | Idaho | 83814 | — |
| Forest Investigative Site 119 | Eagle | Idaho | 83616 | — |
| Forest Investigative Site 201 | Bolingbrook | Illinois | 60490 | — |
| Forest Investigative Site 206 | Downers Grove | Illinois | 60515 | — |
| Forest Investigative Site 136 | Elk Grove Village | Illinois | 60007 | — |
| Forest Investigative Site 139 | Oak Lawn | Illinois | 60453 | — |
| Forest Investigative Site 227 | Peoria | Illinois | 61637 | — |
| Forest Investigative Site 334 | Springfield | Illinois | 62703 | — |
| Forest Investigative Site 263 | Elwood | Indiana | 46036 | — |
| Forest Investigative Site 342 | Lafayette | Indiana | 47904 | — |
| Forest Investigative Site 293 | Michigan City | Indiana | 46360 | — |
| Forest Investigative Site 264 | Muncie | Indiana | 47303 | — |
| Forest Investigative Site 135 | Council Bluffs | Iowa | 51503 | — |
| Forest Investigative Site 256 | Iowa City | Iowa | 52242 | — |
| Forest Investigative Site 214 | Olathe | Kansas | 66061 | — |
| Forest Investigative Site 316 | Topeka | Kansas | 66606 | — |
| Forest Investigative Site 301 | Wichita | Kansas | 67205 | — |
| Forest Investigative Site 051 | Bowling Green | Kentucky | 42101 | — |
| Forest Investigative Site 075 | Crescent Springs | Kentucky | 41017 | — |
| Forest Investigative Site 351 | Hazard | Kentucky | 41701 | — |
| Forest Investigative Site 068 | Lexington | Kentucky | 40504 | — |
| Forest Investigative Site 088 | Louisville | Kentucky | 40215 | — |
| Forest Investigative Site 053 | Owensboro | Kentucky | 42303 | — |
| Forest Investigative Site 273 | Lafayette | Louisiana | 70503 | — |
| Forest Investigative Site 070 | Opelousas | Louisiana | 70570 | — |
| Forest Investigative Site 097 | Sunset | Louisiana | 70584 | — |
| Forest Investigative Site 128 | Lewiston | Maine | 04240 | — |
| Forest Investigative Site 248 | Baltimore | Maryland | 21224 | — |
| Forest Investigative Site 020 | Columbia | Maryland | 21044 | — |
| Forest Investigative Site 072 | Towson | Maryland | 21204 | — |
| Forest Investigative Site 106 | Fall River | Massachusetts | 02720 | — |
| Forest Investigative Site 044 | North Dartmouth | Massachusetts | 02747 | — |
| Forest Investigative Site 350 | Pittsfield | Massachusetts | 01201 | — |
| Forest Investigative Site 157 | Ann Arbor | Michigan | 48106 | — |
| Forest Investigative Site 341 | Detroit | Michigan | 48202 | — |
| Forest Investigative Site 328 | Kalamazoo | Michigan | 49009 | — |
| Forest Investigative Site 063 | Livonia | Michigan | 48152 | — |
| Forest Investigative Site 322 | Saint Joseph | Michigan | 49085 | — |
| Forest Investigative Site 303 | Edina | Minnesota | 55435 | — |
| Forest Investigative Site 056 | Fridley | Minnesota | 55432 | — |
| Forest Investigative Site 082 | Rochester | Minnesota | 55905 | — |
| Forest Investigative Site 033 | Chesterfield | Missouri | 63017 | — |
| Forest Investigative Site 098 | Saint Charles | Missouri | 63301 | — |
| Forest Investigative Site 117 | Springfield | Missouri | 65803 | — |
| Forest Investigative Site 186 | St Louis | Missouri | 63141 | — |
| Forest Investigative Site 288 | St Louis | Missouri | 63143 | — |
| Forest Investigative Site 333 | Butte | Montana | 59701 | — |
| Forest Investigative Site 029 | Missoula | Montana | 59808 | — |
| Forest Investigative Site 197 | Bellevue | Nebraska | 68123 | — |
| Forest Investigative Site 267 | Fremont | Nebraska | 68025 | — |
| Forest Investigative Site 337 | Fremont | Nebraska | 68028 | — |
| Forest Investigative Site 315 | Lincoln | Nebraska | 68506 | — |
| Forest Investigative Site 108 | Lincoln | Nebraska | 68510 | — |
| Forest Investigative Site 345 | Omaha | Nebraska | 68114 | — |
| Forest Investigative Site 079 | Henderson | Nevada | 89014 | — |
| Forest Investigative Site 270 | Henderson | Nevada | 89052 | — |
| Forest Investigative Site 067 | Cherry Hill | New Jersey | 08003 | — |
| Forest Investigative Site 327 | Clifton | New Jersey | 07012 | — |
| Forest Investigative Site 144 | Hackensack | New Jersey | 07601 | — |
| Forest Investigative Site 317 | Summit | New Jersey | 07901 | — |
| Forest Investigative Site 226 | Brooklyn | New York | 11229 | — |
| Forest Investigative Site 199 | Great Neck | New York | 11021 | — |
| Forest Investigative Site 071 | New York | New York | 10029 | — |
| Forest Investigative Site 013 | Rochester | New York | 14618 | — |
| Forest Investigative Site 066 | Syracuse | New York | 13210 | — |
| Forest Investigative Site 158 | West Seneca | New York | 14224 | — |
| Forest Investigative Site 313 | Asheville | North Carolina | 28801 | — |
| Forest Investigative Site 193 | Burlington | North Carolina | 27215 | — |
| Forest Investigative Site 142 | Charlotte | North Carolina | 28207 | — |
| Forest Investigative Site 259 | Charlotte | North Carolina | 28277 | — |
| Forest Investigative Site 019 | Elizabeth City | North Carolina | 27909 | — |
| Forest Investigative Site 318 | Shelby | North Carolina | 28150 | — |
| Forest Investigative Site 078 | Shelby | North Carolina | 28152 | — |
| Forest Investigative Site 176 | Wilmington | North Carolina | 28451 | — |
| Forest Investigative Site 282 | Winston-Salem | North Carolina | 27103 | — |
| Forest Investigative Site 314 | Winston-Salem | North Carolina | 27103 | — |
| Forest Investigative Site 164 | Canton | Ohio | 44718 | — |
| Forest Investigative Site 149 | Cincinnati | Ohio | 45219 | — |
| Forest Investigative Site 061 | Cincinnati | Ohio | 45231 | — |
| Forest Investigative Site 040 | Cincinnati | Ohio | 45242 | — |
| Forest Investigative Site 280 | Cincinnati | Ohio | 45267 | — |
| Forest Investigative Site 009 | Columbus | Ohio | 43213 | — |
| Forest Investigative Site 353 | Dayton | Ohio | 45439 | — |
| Forest Investigative Site 059 | Marion | Ohio | 43302 | — |
| Forest Investigative Site 154 | Marion | Ohio | 43302 | — |
| Forest Investigative Site 346 | Toledo | Ohio | 43606 | — |
| Forest Investigative Site 105 | Zanesville | Ohio | 43701 | — |
| Forest Investigative Site 167 | Oklahoma City | Oklahoma | 73103 | — |
| Forest Investigative Site 281 | Oklahoma City | Oklahoma | 73103 | — |
| Forest Investigative Site 236 | Tulsa | Oklahoma | 74135 | — |
| Forest Investigative Site 285 | Medford | Oregon | 97501 | — |
| Forest Investigative Site 289 | Portland | Oregon | 97220 | — |
| Forest Investigative Site 218 | Portland | Oregon | 97227 | — |
| Forest Investigative Site 086 | Altoona | Pennsylvania | 16601 | — |
| Forest Investigative Site 340 | Beaver | Pennsylvania | 15009 | — |
| Forest Investigative Site 120 | Downingtown | Pennsylvania | 19335 | — |
| Forest Investigative Site 062 | Erie | Pennsylvania | 16506 | — |
| Forest Investigative Site 277 | Norristown | Pennsylvania | 19401 | — |
| Forest Investigative Site 230 | Philadelphia | Pennsylvania | 19107 | — |
| Forest Investigative Site 205 | Philadelphia | Pennsylvania | 19140 | — |
| Forest Investigative Site 336 | Pittsburgh | Pennsylvania | 15221 | — |
| Forest Investigative Site 364 | Pittsburgh | Pennsylvania | 15240 | — |
| Forest Investigative Site 344 | Pittsburgh | Pennsylvania | 15243 | — |
| Forest Investigative Site 010 | Tipton | Pennsylvania | 16684 | — |
| Forest Investigative Site 064 | Uniontown | Pennsylvania | 15401 | — |
| Forest Investigative Site 228 | Johnston | Rhode Island | 02919 | — |
| Forest Investigative Site 283 | Lincoln | Rhode Island | 02865 | — |
| Forest Investigative Site 365 | Providence | Rhode Island | 02903 | — |
| Forest Investigative Site 305 | Charleston | South Carolina | 29406 | — |
| Forest Investigative Site 093 | Easley | South Carolina | 29640 | — |
| Forest Investigative Site 257 | Fort Mill | South Carolina | 29707 | — |
| Forest Investigative Site 233 | Gaffney | South Carolina | 29340 | — |
| Forest Investigative Site 110 | Greenville | South Carolina | 29615 | — |
| Forest Investigative Site 300 | Pelzer | South Carolina | 29669 | — |
| Forest Investigative Site 204 | Rock Hill | South Carolina | 29732 | — |
| Forest Investigative Site 021 | Spartanburg | South Carolina | 29303 | — |
| Forest Investigative Site 012 | Union | South Carolina | 29379 | — |
| Forest Investigative Site 058 | Rapid City | South Dakota | 57702 | — |
| Forest Investigative Site 223 | Bristol | Tennessee | 37620 | — |
| Forest Investigative Site 050 | Fayetteville | Tennessee | 37334 | — |
| Forest Investigative Site 253 | Shelbyville | Tennessee | 37160 | — |
| Forest Investigative Site 024 | Arlington | Texas | 76012 | — |
| Forest Investigative Site 177 | Boerne | Texas | 78006 | — |
| Forest Investigative Site 090 | Corsicana | Texas | 75110 | — |
| Forest Investigative Site 172 | Dallas | Texas | 75246 | — |
| Forest Investigative Site 237 | Houston | Texas | 77030 | — |
| Forest Investigative Site 271 | Houston | Texas | 77030 | — |
| Forest Investigative Site 370 | Houston | Texas | 77030 | — |
| Forest Investigative Site 195 | Houston | Texas | 77034 | — |
| Forest Investigative Site 312 | Houston | Texas | 77079 | — |
| Forest Investigative Site 332 | Huntsville | Texas | 77340 | — |
| Forest Investigative Site 232 | Longview | Texas | 75605 | — |
| Forest Investigative Site 049 | Tyler | Texas | 75708 | — |
| Forest Investigative Site 181 | Colchester | Vermont | 05446 | — |
| Forest Investigative Site 125 | Abingdon | Virginia | 24210 | — |
| Forest Investigative Site 202 | Richmond | Virginia | 23225 | — |
| Forest Investigative Site 231 | Richmond | Virginia | 23229 | — |
| Forest Investigative Site 045 | Richmond | Virginia | 23233 | — |
| Forest Investigative Site 184 | Spokane | Washington | 99202 | — |
| Forest Investigative Site 174 | Spokane | Washington | 99204 | — |
| Forest Investigative Site 217 | Tacoma | Washington | 98405 | — |
| Forest Investigative Site 335 | Charleston | West Virginia | 25304 | — |
| Forest Investigative Site 319 | Morgantown | West Virginia | 26505 | — |
| Forest Investigative Site 146 | West Allis | Wisconsin | 53227 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 121 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01443845, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2017 · Synced Nov 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01443845 live on ClinicalTrials.gov.