COPD Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 2354 |
| Est. completion date | January 2016 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - 1. Male or female patients at least 40 years of age - 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease [GOLD] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted) - 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) < 70% at Screening (Visit 1) - 4. FEV1 (postbronchodilator) = 50% of predicted at Screening (Visit 1) - 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1) - 6. Patients must be on FDC LABA/ICS treatment = 3 months prior to Screening (Visit 1) - 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years Exclusion Criteria: - 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable) - 2. Known alpha-1-antitrypsin deficiency - 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.) - 4. Body mass index (BMI) = 45 kg/m2 - 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Forest Investigative Site 403 | Buenos Aires | |
| Argentina | Forest Investigative Site 411 | Ciudad Autonoma de Buenos Aires | |
| Argentina | Forest Investigative Site 414 | Ciudad Autonoma de Buenos Aires | |
| Argentina | Forest Investigative Site 416 | Ciudad Autonoma de Buenos Aires | |
| Argentina | Forest Investigative Site 418 | Ciudad Autonoma de Buenos Aires | Buenos Aires |
| Argentina | Forest Investigative Site 419 | Ciudad Autonoma de Buenos Aires | |
| Argentina | Forest Investigative Site 415 | Derqui Pilar - Buenos Aires | |
| Argentina | Forest Investigative Site 410 | Florencio Varela | |
| Argentina | Forest Investigative Site 402 | Florida | Buenos Aires |
| Argentina | Forest Investigative Site 405 | La Plata | Buenos Aires |
| Argentina | Forest Investigative Site 417 | La Plata | |
| Argentina | Forest Investigative Site 406 | Lanús Este | Provincia de Buenos Aires |
| Argentina | Forest Investigative Site 413 | Mar del Plata | Buenos Aires |
| Argentina | Forest Investigative Site 404 | Mendoza | |
| Argentina | Forest Investigative Site 420 | Mendoza | |
| Argentina | Forest Investigative Site 407 | Parana | Entre Rios |
| Argentina | Forest Investigative Site 409 | Rosario | Santa Fe |
| Argentina | Forest Investigative Site 412 | Rosario | Santa Fe |
| Argentina | Forest Investigative Site 401 | San Miguel de Tucuman | |
| Argentina | Forest Investigative Site 408 | Santa Fe | |
| Canada | Forest Investigative Site 302 | Burlington | Ontario |
| Canada | Forest Investigative Site 235 | Calgary | Alberta |
| Canada | Forest Investigative Site 185 | Montreal | Quebec |
| Canada | Forest Investigative Site 162 | North Vancouver | British Columbia |
| Canada | Forest Investigative Site 127 | Saskatoon | Saskatchewan |
| Chile | Forest Investigative Site 421 | Talcahuano | |
| Colombia | Forest Investigative Site 442 | Bogota | |
| Colombia | Forest Investigative Site 443 | Bogota | |
| Italy | Forest Investigative Site 461 | Chieti | |
| Italy | Forest Investigative Site 464 | Roma | |
| Malaysia | Forest Investigative Site 505 | Batu Caves | |
| Malaysia | Forest Investigative Site 501 | Kuala Lumpur | |
| Malaysia | Forest Investigative Site 504 | Kuala Lumpur | |
| Malaysia | Forest Investigative Site 502 | Kuantan | |
| Mexico | Forest Investigative Site 524 | Guadalajara | |
| Mexico | Forest Investigative Site 526 | Merida | Yucatan |
| Mexico | Forest Investigative Site 521 | Monterrey | |
| Mexico | Forest Investigative Site 522 | Monterrey | Nuevo León |
| Peru | Forest Investigative Site 543 | Bellavista | |
| Peru | Forest Investigative Site 544 | Lima | |
| Peru | Forest Investigative Site 545 | Lima | |
| Peru | Forest Investigative Site 546 | Lima | |
| Peru | Forest Investigative Site 549 | Lima | |
| Peru | Forest Investigative Site 550 | Lima | |
| Peru | Forest Investigative Site 551 | Lima | |
| Peru | Forest Investigative Site 541 | Pueblo Libre | |
| Philippines | Forest Investigative Site 569 | Cavite | |
| Philippines | Forest Investigative Site 567 | Iloilo City | |
| Philippines | Forest Investigative Site 568 | Iloilo City | |
| Philippines | Forest Investigative Site 565 | Manila | |
| Philippines | Forest Investigative Site 563 | Pasig City | |
| Philippines | Forest Investigative Site 561 | Quezon City | |
| Philippines | Forest Investigative Site 562 | Quezon City | |
| Philippines | Forest Investigative Site 564 | Quezon City | |
| Philippines | Forest Investigative Site 566 | Quezon City | |
| Romania | Forest Investigative Site 585 | Brasov | |
| Romania | Forest Investigative Site 582 | Bucharest | |
| Romania | Forest Investigative Site 584 | Bucharest | |
| Romania | Forest Investigative Site 586 | Bucharest | |
| Romania | Forest Investigative Site 587 | Bucharest | |
| Romania | Forest Investigative Site 588 | Bucharest | |
| Romania | Forest Investigative Site 581 | Iasi | |
| Romania | Forest Investigative Site 583 | Iasi | |
| Russian Federation | Forest Investigative Site 608 | Barnaul | |
| Russian Federation | Forest Investigative Site 602 | Kazan | |
| Russian Federation | Forest Investigative Site 618 | Kemerovo | |
| Russian Federation | Forest Investigative Site 609 | Krasnodar | |
| Russian Federation | Forest Investigative Site 614 | Krasnoyarsk | |
| Russian Federation | Forest Investigative Site 617 | Moscow | |
| Russian Federation | Forest Investigative Site 605 | Novosibirsk | |
| Russian Federation | Forest Investigative Site 600 | St Petersburg | |
| Russian Federation | Forest Investigative Site 601 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 604 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 610 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 611 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 612 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 619 | St. Petersburg | |
| Russian Federation | Forest Investigative Site 606 | St.Petersburg | |
| Russian Federation | Forest Investigative Site 607 | Tomsk | |
| Russian Federation | Forest Investigative Site 620 | Yaroslavl | |
| Serbia | Forest Investigative Site 622 | Belgrade | |
| Serbia | Forest Investigative Site 623 | Belgrade | |
| Serbia | Forest Investigative Site 624 | Belgrade | |
| Serbia | Forest Investigative Site 625 | Beograd | |
| Serbia | Forest Investigative Site 629 | Knez Selo | Nišava District |
| Serbia | Forest Investigative Site 628 | Kragujevac | |
| Serbia | Forest Investigative Site 627 | Sremska Kamenica | |
| Spain | Forest Investigative Site 641 | Cadiz | |
| Spain | Forest Investigative Site 647 | Loja | |
| Spain | Forest Investigative Site 644 | Salt | |
| Taiwan | Forest Investigative Site 723 | Kaohsiung Hsien | |
| Taiwan | Forest Investigative Site 724 | Puzih City | |
| Taiwan | Forest Investigative Site 722 | Taipei | |
| Taiwan | Forest Investigative Site 725 | Taipei | |
| Thailand | Forest Investigative Site 663 | Bangkok | |
| Thailand | Forest Investigative Site 664 | Bangkok | |
| Thailand | Forest Investigative Site 662 | Hat Yai | Songkhla |
| Thailand | Forest Investigative Site 661 | Muang | |
| Ukraine | Forest Investigative Site 699 | Cherkasy | |
| Ukraine | Forest Investigative Site 691 | Dnipropetrovsk | |
| Ukraine | Forest Investigative Site 689 | Donetsk | |
| Ukraine | Forest Investigative Site 692 | Donetsk | |
| Ukraine | Forest Investigative Site 690 | Ivano-Frankivsk | |
| Ukraine | Forest Investigative Site 682 | Kharkiv | |
| Ukraine | Forest Investigative Site 693 | Kharkiv | |
| Ukraine | Forest Investigative Site 697 | Kharkiv | |
| Ukraine | Forest Investigative Site 709 | Kremenchuk | |
| Ukraine | Forest Investigative Site 683 | Kyiv | |
| Ukraine | Forest Investigative Site 684 | Kyiv | |
| Ukraine | Forest Investigative Site 685 | Kyiv | |
| Ukraine | Forest Investigative Site 687 | Kyiv | |
| Ukraine | Forest Investigative Site 698 | Kyiv | |
| Ukraine | Forest Investigative Site 681 | Lviv | |
| Ukraine | Forest Investigative Site 708 | Mykolayiv | |
| Ukraine | Forest Investigative Site 706 | Poltava | |
| Ukraine | Forest Investigative Site 695 | Sumy | |
| Ukraine | Forest Investigative Site 707 | Vinnitsa | |
| Ukraine | Forest Investigative Site 688 | Zaporizhzhia | |
| Ukraine | Forest Investigative Site 694 | Zaporizhzhya | |
| Ukraine | Forest Investigative Site 696 | Zaporizhzhya | |
| Ukraine | Forest Investigative Site 705 | Zaporizhzhya | |
| United States | Forest Investigative Site 125 | Abingdon | Virginia |
| United States | Forest Investigative Site 086 | Altoona | Pennsylvania |
| United States | Forest Investigative Site 157 | Ann Arbor | Michigan |
| United States | Forest Investigative Site 081 | Anniston | Alabama |
| United States | Forest Investigative Site 024 | Arlington | Texas |
| United States | Forest Investigative Site 313 | Asheville | North Carolina |
| United States | Forest Investigative Site 065 | Athens | Alabama |
| United States | Forest Investigative Site 248 | Baltimore | Maryland |
| United States | Forest Investigative Site 340 | Beaver | Pennsylvania |
| United States | Forest Investigative Site 197 | Bellevue | Nebraska |
| United States | Forest Investigative Site 074 | Bellflower | California |
| United States | Forest Investigative Site 177 | Boerne | Texas |
| United States | Forest Investigative Site 201 | Bolingbrook | Illinois |
| United States | Forest Investigative Site 051 | Bowling Green | Kentucky |
| United States | Forest Investigative Site 196 | Brandon | Florida |
| United States | Forest Investigative Site 224 | Brandon | Florida |
| United States | Forest Investigative Site 358 | Brandon | Florida |
| United States | Forest Investigative Site 223 | Bristol | Tennessee |
| United States | Forest Investigative Site 226 | Brooklyn | New York |
| United States | Forest Investigative Site 193 | Burlington | North Carolina |
| United States | Forest Investigative Site 333 | Butte | Montana |
| United States | Forest Investigative Site 103 | Canton | Georgia |
| United States | Forest Investigative Site 164 | Canton | Ohio |
| United States | Forest Investigative Site 305 | Charleston | South Carolina |
| United States | Forest Investigative Site 335 | Charleston | West Virginia |
| United States | Forest Investigative Site 142 | Charlotte | North Carolina |
| United States | Forest Investigative Site 259 | Charlotte | North Carolina |
| United States | Forest Investigative Site 067 | Cherry Hill | New Jersey |
| United States | Forest Investigative Site 033 | Chesterfield | Missouri |
| United States | Forest Investigative Site 166 | Chiefland | Florida |
| United States | Forest Investigative Site 061 | Cincinatti | Ohio |
| United States | Forest Investigative Site 040 | Cincinnati | Ohio |
| United States | Forest Investigative Site 149 | Cincinnati | Ohio |
| United States | Forest Investigative Site 280 | Cincinnati | Ohio |
| United States | Forest Investigative Site 111 | Clearwater | Florida |
| United States | Forest Investigative Site 123 | Clearwater | Florida |
| United States | Forest Investigative Site 327 | Clifton | New Jersey |
| United States | Forest Investigative Site 008 | Coeur d' Alene | Idaho |
| United States | Forest Investigative Site 181 | Colchester | Vermont |
| United States | Forest Investigative Site 020 | Columbia | Maryland |
| United States | Forest Investigative Site 009 | Columbus | Ohio |
| United States | Forest Investigative Site 291 | Coral Gables | Florida |
| United States | Forest Investigative Site 090 | Corsicana | Texas |
| United States | Forest Investigative Site 135 | Council Bluffs | Iowa |
| United States | Forest Investigative Site 075 | Crescent Springs | Kentucky |
| United States | Forest Investigative Site 172 | Dallas | Texas |
| United States | Forest Investigative Site 292 | Dawsonville | Georgia |
| United States | Forest Investigative Site 353 | Dayton | Ohio |
| United States | Forest Investigative Site 239 | DeFuniak Springs | Florida |
| United States | Forest Investigative Site 341 | Detroit | Michigan |
| United States | Forest Investigative Site 206 | Downers Grove | Illinois |
| United States | Forest Investigative Site 120 | Downingtown | Pennsylvania |
| United States | Forest Investigative Site 042 | Duluth | Georgia |
| United States | Forest Investigative Site 119 | Eagle | Idaho |
| United States | Forest Investigative Site 093 | Easley | South Carolina |
| United States | Forest Investigative Site 303 | Edina | Minnesota |
| United States | Forest Investigative Site 019 | Elizabeth City | North Carolina |
| United States | Forest Investigative Site 136 | Elk Grove Village | Illinois |
| United States | Forest Investigative Site 263 | Elwood | Indiana |
| United States | Forest Investigative Site 062 | Erie | Pennsylvania |
| United States | Forest Investigative Site 106 | Fall River | Massachusetts |
| United States | Forest Investigative Site 050 | Fayetteville | Tennessee |
| United States | Forest Investigative Site 131 | Florence | Alabama |
| United States | Forest Investigative Site 001 | Fort Lauderdale | Florida |
| United States | Forest Investigative Site 257 | Fort Mill | South Carolina |
| United States | Forest Investigative Site 208 | Fort Smith | Arkansas |
| United States | Forest Investigative Site 165 | Fort Walton Beach | Florida |
| United States | Forest Investigative Site 267 | Fremont | Nebraska |
| United States | Forest Investigative Site 337 | Fremont | Nebraska |
| United States | Forest Investigative Site 060 | Fresno | California |
| United States | Forest Investigative Site 329 | Fresno | California |
| United States | Forest Investigative Site 056 | Fridley | Minnesota |
| United States | Forest Investigative Site 245 | Fullerton | California |
| United States | Forest Investigative Site 233 | Gaffney | South Carolina |
| United States | Forest Investigative Site 102 | Gainesville | Florida |
| United States | Forest Investigative Site 140 | Gainesville | Georgia |
| United States | Forest Investigative Site 310 | Garden Grove | California |
| United States | Forest Investigative Site 199 | Great Neck | New York |
| United States | Forest Investigative Site 110 | Greenville | South Carolina |
| United States | Forest Investigative Site 144 | Hackensack | New Jersey |
| United States | Forest Investigative Site 351 | Hazard | Kentucky |
| United States | Forest Investigative Site 079 | Henderson | Nevada |
| United States | Forest Investigative Site 270 | Henderson | Nevada |
| United States | Forest Investigative Site 003 | Hollywood | Florida |
| United States | Forest Investigative Site 195 | Houston | Texas |
| United States | Forest Investigative Site 237 | Houston | Texas |
| United States | Forest Investigative Site 271 | Houston | Texas |
| United States | Forest Investigative Site 312 | Houston | Texas |
| United States | Forest Investigative Site 370 | Houston | Texas |
| United States | Forest Investigative Site 332 | Huntsville | Texas |
| United States | Forest Investigative Site 256 | Iowa City | Iowa |
| United States | Forest Investigative Site 023 | Jacksonville | Florida |
| United States | Forest Investigative Site 228 | Johnston | Rhode Island |
| United States | Forest Investigative Site 328 | Kalamazoo | Michigan |
| United States | Forest Investigative Site 077 | Kissimmee | Florida |
| United States | Forest Investigative Site 330 | Kissimmee | Florida |
| United States | Forest Investigative Site 273 | Lafayette | Louisiana |
| United States | Forest Investigative Site 342 | Lafayette | Indiana |
| United States | Forest Investigative Site 297 | Lakewood | California |
| United States | Forest Investigative Site 030 | Lawrenceville | Georgia |
| United States | Forest Investigative Site 128 | Lewiston | Maine |
| United States | Forest Investigative Site 068 | Lexington | Kentucky |
| United States | Forest Investigative Site 108 | Lincoln | Nebraska |
| United States | Forest Investigative Site 283 | Lincoln | Rhode Island |
| United States | Forest Investigative Site 315 | Lincoln | Nebraska |
| United States | Forest Investigative Site 101 | Little Rock | Arkansas |
| United States | Forest Investigative Site 063 | Livonia | Michigan |
| United States | Forest Investigative Site 116 | Long Beach | California |
| United States | Forest Investigative Site 232 | Longview | Texas |
| United States | Forest Investigative Site 085 | Los Angeles | California |
| United States | Forest Investigative Site 241 | Los Angeles | California |
| United States | Forest Investigative Site 088 | Louisville | Kentucky |
| United States | Forest Investigative Site 059 | Marion | Ohio |
| United States | Forest Investigative Site 154 | Marion | Ohio |
| United States | Forest Investigative Site 285 | Medford | Oregon |
| United States | Forest Investigative Site 272 | Mesa | Arizona |
| United States | Forest Investigative Site 027 | Miami | Florida |
| United States | Forest Investigative Site 115 | Miami | Florida |
| United States | Forest Investigative Site 229 | Miami | Florida |
| United States | Forest Investigative Site 339 | Miami | Florida |
| United States | Forest Investigative Site 293 | Michigan City | Indiana |
| United States | Forest Investigative Site 029 | Missoula | Montana |
| United States | Forest Investigative Site 073 | Mobile | Alabama |
| United States | Forest Investigative Site 319 | Morgantown | West Virginia |
| United States | Forest Investigative Site 264 | Muncie | Indiana |
| United States | Forest Investigative Site 092 | Naples | Florida |
| United States | Forest Investigative Site 071 | New York | New York |
| United States | Forest Investigative Site 124 | Newark | Delaware |
| United States | Forest Investigative Site 277 | Norristown | Pennsylvania |
| United States | Forest Investigative Site 044 | North Dartmouth | Massachusetts |
| United States | Forest Investigative Site 299 | Northridge | California |
| United States | Forest Investigative Site 139 | Oak Lawn | Illinois |
| United States | Forest Investigative Site 167 | Oklahoma City | Oklahoma |
| United States | Forest Investigative Site 281 | Oklahoma City | Oklahoma |
| United States | Forest Investigative Site 214 | Olathe | Kansas |
| United States | Forest Investigative Site 345 | Omaha | Nebraska |
| United States | Forest Investigative Site 070 | Opelousas | Louisiana |
| United States | Forest Investigative Site 004 | Orlando | Florida |
| United States | Forest Investigative Site 187 | Ormond Beach | Florida |
| United States | Forest Investigative Site 053 | Owensboro | Kentucky |
| United States | Forest Investigative Site 213 | Palo Alto | California |
| United States | Forest Investigative Site 300 | Pelzer | South Carolina |
| United States | Forest Investigative Site 069 | Pensacola | Florida |
| United States | Forest Investigative Site 091 | Peoria | Arizona |
| United States | Forest Investigative Site 227 | Peoria | Illinois |
| United States | Forest Investigative Site 205 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 230 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 034 | Phoenix | Arizona |
| United States | Forest Investigative Site 188 | Phoenix | Arizona |
| United States | Forest Investigative Site 211 | Phoenix | Arizona |
| United States | Forest Investigative Site 247 | Phoenix | Arizona |
| United States | Forest Investigative Site 268 | Pismo Beach | California |
| United States | Forest Investigative Site 336 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 344 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 364 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 350 | Pittsfield | Massachusetts |
| United States | Forest Investigative Site 161 | Ponte Vedra | Florida |
| United States | Forest Investigative Site 087 | Port Orange | Florida |
| United States | Forest Investigative Site 218 | Portland | Oregon |
| United States | Forest Investigative Site 289 | Portland | Oregon |
| United States | Forest Investigative Site 365 | Providence | Rhode Island |
| United States | Forest Investigative Site 058 | Rapid City | South Dakota |
| United States | Forest Investigative Site 045 | Richmond | Virginia |
| United States | Forest Investigative Site 202 | Richmond | Virginia |
| United States | Forest Investigative Site 231 | Richmond | Virginia |
| United States | Forest Investigative Site 025 | Riverside | California |
| United States | Forest Investigative Site 013 | Rochester | New York |
| United States | Forest Investigative Site 082 | Rochester | Minnesota |
| United States | Forest Investigative Site 204 | Rock Hill | South Carolina |
| United States | Forest Investigative Site 143 | Roseville | California |
| United States | Forest Investigative Site 104 | Sacramento | California |
| United States | Forest Investigative Site 322 | Saint Joseph | Michigan |
| United States | Forest Investigative Site 357 | Saint Petersburg | Florida |
| United States | Forest Investigative Site 038 | San Diego | California |
| United States | Forest Investigative Site 352 | San Diego | California |
| United States | Forest Investigative Site 326 | San Jose | California |
| United States | Forest Investigative Site 078 | Shelby | North Carolina |
| United States | Forest Investigative Site 318 | Shelby | North Carolina |
| United States | Forest Investigative Site 253 | Shelbyville | Tennessee |
| United States | Forest Investigative Site 021 | Spartanburg | South Carolina |
| United States | Forest Investigative Site 174 | Spokane | Washington |
| United States | Forest Investigative Site 184 | Spokane | Washington |
| United States | Forest Investigative Site 117 | Springfield | Missouri |
| United States | Forest Investigative Site 334 | Springfield | Illinois |
| United States | Forest Investigative Site 098 | St. Charles | Missouri |
| United States | Forest Investigative Site 109 | St. Cloud | Florida |
| United States | Forest Investigative Site 186 | St. Louis | Missouri |
| United States | Forest Investigative Site 288 | St. Louis | Missouri |
| United States | Forest Investigative Site 121 | St. Petersburg | Florida |
| United States | Forest Investigative Site 331 | Stamford | Connecticut |
| United States | Forest Investigative Site 317 | Summit | New Jersey |
| United States | Forest Investigative Site 097 | Sunset | Louisiana |
| United States | Forest Investigative Site 066 | Syracuse | New York |
| United States | Forest Investigative Site 217 | Tacoma | Washington |
| United States | Forest Investigative Site 002 | Tamarac | Florida |
| United States | Forest Investigative Site 052 | Tampa | Florida |
| United States | Forest Investigative Site 287 | Tampa | Florida |
| United States | Forest Investigative Site 010 | Tipton | Pennsylvania |
| United States | Forest Investigative Site 346 | Toledo | Ohio |
| United States | Forest Investigative Site 316 | Topeka | Kansas |
| United States | Forest Investigative Site 209 | Torrance | California |
| United States | Forest Investigative Site 072 | Towson | Maryland |
| United States | Forest Investigative Site 236 | Tulsa | Oklahoma |
| United States | Forest Investigative Site 049 | Tyler | Texas |
| United States | Forest Investigative Site 012 | Union | South Carolina |
| United States | Forest Investigative Site 064 | Uniontown | Pennsylvania |
| United States | Forest Investigative Site 017 | Waterbury | Connecticut |
| United States | Forest Investigative Site 146 | West Allis | Wisconsin |
| United States | Forest Investigative Site 158 | West Seneca | New York |
| United States | Forest Investigative Site 301 | Wichita | Kansas |
| United States | Forest Investigative Site 176 | Wilmington | North Carolina |
| United States | Forest Investigative Site 314 | Winston Salem | North Carolina |
| United States | Forest Investigative Site 282 | Winston-Salem | North Carolina |
| United States | Forest Investigative Site 011 | Winter Park | Florida |
| United States | Forest Investigative Site 348 | Winter Park | Florida |
| United States | Forest Investigative Site 321 | Woodstock | Georgia |
| United States | Forest Investigative Site 105 | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories |
United States, Argentina, Canada, Chile, Colombia, Italy, Malaysia, Mexico, Peru, Philippines, Romania, Russian Federation, Serbia, Spain, Taiwan, Thailand, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of moderate or severe COPD exacerbations per subject per year | 52 Weeks | No | |
| Secondary | Prebronchodilator Forced Expiratory Volume in 1 second (FEV1) in Liters | Change from randomization, Week 0 (Visit 2) to Week 52 | No |
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