ClinicalTrials.gov record
Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01572792
Public ClinicalTrials.gov record NCT01572792. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Long-term, Randomized, Double-blind, Extension Study of the Efficacy, Safety, and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28- Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.
Study identification
- NCT ID
- NCT01572792
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 921 participants
Conditions and interventions
Conditions
Interventions
- Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) Drug
- Aclidinium bromide Drug
- Formoterol Fumarate Drug
- Placebo Drug
Drug
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
- Apr 2012 (Type not available)
- Primary completion
- Jun 2013 (Actual)
- Completion
- Jun 2013 (Actual)
- Last update posted
- Apr 21, 2017
2012 – 2013
United States locations
- U.S. sites
- 179
- U.S. states
- 38
- U.S. cities
- 149
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 1827 | Anniston | Alabama | 36207 | — |
| Forest Investigative Site 1920 | Athens | Alabama | 35611 | — |
| Forest Investigative Site 1162 | Birmingham | Alabama | 35209 | — |
| Forest Investigative Site 1493 | Birmingham | Alabama | 35209 | — |
| Forest Investigative Site 1937 | Birmingham | Alabama | 35216 | — |
| Forest Investigative Site 1824 | Gulf Shores | Alabama | 36542 | — |
| Forest Investigative Site 2088 | Jasper | Alabama | 35501 | — |
| Forest Investigative Site 1918 | Scottsboro | Alabama | 35768 | — |
| Forest Investigative Site 0909 | Glendale | Arizona | 85306 | — |
| Forest Investigative Site 1379 | Phoenix | Arizona | 85018 | — |
| Forest Investigative Site 1822 | Anaheim | California | 92801 | — |
| Forest Investigative Site 1483 | Buena Park | California | 90620 | — |
| Forest Investigative Site 1156 | Fresno | California | 93726 | — |
| Forest Investigative Site 1871 | Lincoln | California | 95648 | — |
| Forest Investigative Site 1873 | Los Angeles | California | 90073 | — |
| Forest Investigative Site 2064 | Riverside | California | 92506 | — |
| Forest Investigative Site 1427 | Sacramento | California | 95817 | — |
| Forest Investigative Site 1866 | Sacramento | California | 95842 | — |
| Forest Investigative Site 1125 | San Diego | California | 92103 | — |
| Forest Investigative Site 2009 | San Diego | California | 92120 | — |
| Forest Investigative Site 1374 | Torrance | California | 90505 | — |
| Forest Investigative Site 1813 | Tustin | California | 92780 | — |
| Forest Investigative Site 1883 | Vista | California | 92083 | — |
| Forest Investigative Site 1380 | Golden | Colorado | 80401 | — |
| Forest Investigative Site 1137 | Pueblo | Colorado | 81001 | — |
| Forest Investigative Site 1327 | Wheat Ridge | Colorado | 80033 | — |
| Forest Investigative Site 1976 | Waterbury | Connecticut | 06708 | — |
| Forest Investigative Site 1821 | Bay Pines | Florida | 33744 | — |
| Forest Investigative Site 1154 | Brandon | Florida | 33511 | — |
| Forest Investigative Site 1944 | Brandon | Florida | 33511 | — |
| Forest Investigative Site 1364 | Clearwater | Florida | 33756 | — |
| Forest Investigative Site 1152 | Clearwater | Florida | 33765 | — |
| Forest Investigative Site 1875 | Clearwater | Florida | 33765 | — |
| Forest Investigative Site 1811 | Covington | Florida | 70433 | — |
| Forest Investigative Site 0670 | DeLand | Florida | 32720 | — |
| Forest Investigative Site 1516 | Edgewater | Florida | 32132 | — |
| Forest Investigative Site 0990 | Fort Lauderdale | Florida | 33316 | — |
| Forest Investigative Site 1513 | Hialeah | Florida | 33012 | — |
| Forest Investigative Site 1854 | Hialeah | Florida | 33012 | — |
| Forest Investigative Site 1882 | Hollywood | Florida | 33024 | — |
| Forest Investigative Site 1543 | Jacksonville | Florida | 32216 | — |
| Forest Investigative Site 1416 | Kissimmee | Florida | 34741 | — |
| Forest Investigative Site 1167 | Melbourne | Florida | 32935 | — |
| Forest Investigative Site 1432 | Miami | Florida | 33143 | — |
| Forest Investigative Site 1819 | Naples | Florida | 34119 | — |
| Forest Investigative Site 1808 | North Miami | Florida | 33179 | — |
| Forest Investigative Site 1950 | Oldsmar | Florida | 34677 | — |
| Forest Investigative Site 1145 | Ormond Beach | Florida | 32174 | — |
| Forest Investigative Site 1094 | Panama City | Florida | 32405 | — |
| Forest Investigative Site 1803 | Pembroke Pines | Florida | 32028 | — |
| Forest Investigative Site 0974 | Pensacola | Florida | 32504 | — |
| Forest Investigative Site 1817 | Sarasota | Florida | 34233 | — |
| Forest Investigative Site 1874 | St. Petersburg | Florida | 33704 | — |
| Forest Investigative Site 2082 | Tamarac | Florida | 33321 | — |
| Forest Investigative Site 2053 | Tampa | Florida | 33603 | — |
| Forest Investigative Site 2047 | Tampa | Florida | 33613 | — |
| Forest Investigative Site 1185 | Winter Park | Florida | 32789 | — |
| Forest Investigative Site 1860 | Winter Park | Florida | 32792 | — |
| Forest Investigative Site 1900 | Atlanta | Georgia | 30312 | — |
| Forest Investigative Site 0987 | Austell | Georgia | 30106 | — |
| Forest Investigative Site 1828 | Canton | Georgia | 30114 | — |
| Forest Investigative Site 1830 | Marietta | Georgia | 30066 | — |
| Forest Investigative Site 2089 | Woodstock | Georgia | 30189 | — |
| Forest Investigative Site 0679 | Coeur d'Alene | Idaho | 83814 | — |
| Forest Investigative Site 1858 | Eagle | Idaho | 83616 | — |
| Forest Investigative Site 1095 | Normal | Illinois | 61761 | — |
| Forest Investigative Site 1912 | Normal | Illinois | 61761 | — |
| Forest Investigative Site 2051 | River Forest | Illinois | 60305 | — |
| Forest Investigative Site 2033 | Bowling Green | Kentucky | 42101 | — |
| Forest Investigative Site 2085 | Fort Mitchell | Kentucky | 41017 | — |
| Forest Investigative Site 0539 | Lexington | Kentucky | 40504 | — |
| Forest Investigative Site 1478 | Louisville | Kentucky | 40217 | — |
| Forest Investigative Site 1519 | Owensboro | Kentucky | 42303 | — |
| Forest Investigative Site 1430 | New Orleans | Louisiana | 70115 | — |
| Forest Investigative Site 1812 | Opelousas | Louisiana | 70570 | — |
| Forest Investigative Site 1814 | Bangor | Maine | 04401 | — |
| Forest Investigative Site 1924 | Baltimore | Maryland | 21237 | — |
| Forest Investigative Site 1872 | Wheaton | Maryland | 20902 | — |
| Forest Investigative Site 1570 | Fall River | Massachusetts | 02720 | — |
| Forest Investigative Site 1852 | Fall River | Massachusetts | 02720 | — |
| Forest Investigative Site 1431 | No. Dartmouth | Massachusetts | 02747 | — |
| Forest Investigative Site 1892 | Ann Arbor | Michigan | 48106 | — |
| Forest Investigative Site 1342 | Stevensville | Michigan | 49127 | — |
| Forest Investigative Site 1487 | Troy | Michigan | 48085 | — |
| Forest Investigative Site 1128 | Edina | Minnesota | 55435 | — |
| Forest Investigative Site 1527 | Fridley | Minnesota | 55432 | — |
| Forest Investigative Site 2041 | Minneapolis | Minnesota | 55402 | — |
| Forest Investigative Site 1124 | Minneapolis | Minnesota | 55407 | — |
| Forest Investigative Site 1619 | Plymouth | Minnesota | 55441 | — |
| Forest Investigative Site 1118 | Rochester | Minnesota | 55905 | — |
| Forest Investigative Site 1884 | Olive Branch | Mississippi | 38654 | — |
| Forest Investigative Site 1602 | Kansas City | Missouri | 64128 | — |
| Forest Investigative Site 1587 | N. Chesterfield | Missouri | 63017 | — |
| Forest Investigative Site 2079 | Saint Charles | Missouri | 63301 | — |
| Forest Investigative Site 1856 | Springfield | Missouri | 65807 | — |
| Forest Investigative Site 1867 | Springfield | Missouri | 65807 | — |
| Forest Investigative Site 1399 | St Louis | Missouri | 63141 | — |
| Forest Investigative Site 1599 | St Louis | Missouri | 63141 | — |
| Forest Investigative Site 1831 | Bozeman | Montana | 59718 | — |
| Forest Investigative Site 1400 | Missoula | Montana | 59808 | — |
| Forest Investigative Site 1609 | Bellevue | Nebraska | 68123 | — |
| Forest Investigative Site 1948 | Fremont | Nebraska | 68025 | — |
| Forest Investigative Site 1815 | Lincoln | Nebraska | 68510 | — |
| Forest Investigative Site 1363 | Omaha | Nebraska | 68114 | — |
| Forest Investigative Site 1907 | Omaha | Nebraska | 68130 | — |
| Forest Investigative Site 1911 | Omaha | Nebraska | 68131 | — |
| Forest Investigative Site 1908 | Omaha | Nebraska | 68134 | — |
| Forest Investigative Site 1804 | Omaha | Nebraska | 68144 | — |
| Forest Investigative Site 1807 | Henderson | Nevada | 89052 | — |
| Forest Investigative Site 1834 | Las Vegas | Nevada | 89128 | — |
| Forest Investigative Site 1562 | Las Vegas | Nevada | 89183 | — |
| Forest Investigative Site 1559 | Cherry Hill | New Jersey | 08003 | — |
| Forest Investigative Site 1923 | Hackensack | New Jersey | 07601 | — |
| Forest Investigative Site 1949 | Albuquerque | New Mexico | 87106 | — |
| Forest Investigative Site 1151 | Great Neck | New York | 11021 | — |
| Forest Investigative Site 1489 | Larchmont | New York | 10538 | — |
| Forest Investigative Site 550 | New York | New York | 10003 | — |
| Forest Investigative Site 1425 | New York | New York | 10028 | — |
| Forest Investigative Site 2098 | Rochester | New York | 14618 | — |
| Forest Investigative Site 1392 | Charlotte | North Carolina | 28277 | — |
| Forest Investigative Site 2035 | Elizabeth City | North Carolina | 27909 | — |
| Forest Investigative Site 1366 | High Point | North Carolina | 27262 | — |
| Forest Investigative Site 1153 | Raleigh | North Carolina | 27607 | — |
| Forest Investigative Site 1823 | Salisbury | North Carolina | 28144 | — |
| Forest Investigative Site 1891 | Cadiz | Ohio | 43907 | — |
| Forest Investigative Site 1134 | Canton | Ohio | 44718 | — |
| Forest Investigative Site 1885 | Cincinnati | Ohio | 45219 | — |
| Forest Investigative Site 1806 | Cincinnati | Ohio | 45231 | — |
| Forest Investigative Site 2028 | Cincinnati | Ohio | 45242 | — |
| Forest Investigative Site 1903 | Cincinnati | Ohio | 45255 | — |
| Forest Investigative Site 1361 | Columbus | Ohio | 43207 | — |
| Forest Investigative Site 1433 | Columbus | Ohio | 43213 | — |
| Forest Investigative Site 2090 | Sylvania | Ohio | 43560 | — |
| Forest Investigative Site 1530 | Toledo | Ohio | 43608 | — |
| Forest Investigative Site 1393 | Zanesville | Ohio | 43701 | — |
| Forest Investigative Site 1915 | Oklahoma City | Oklahoma | 73103 | — |
| Forest Investigative Site 1889 | Bend | Oregon | 97701 | — |
| Forest Investigative Site 2043 | Medford | Oregon | 97504 | — |
| Forest Investigative Site 1833 | Altoona | Pennsylvania | 16601 | — |
| Forest Investigative Site 1820 | Downington | Pennsylvania | 19335 | — |
| Forest Investigative Site 1423 | Erie | Pennsylvania | 16508 | — |
| Forest Investigative Site 1899 | Langhorne | Pennsylvania | 19047 | — |
| Forest Investigative Site 1443 | Philadelphia | Pennsylvania | 19107 | — |
| Forest Investigative Site 1863 | Phoenixville | Pennsylvania | 19460 | — |
| Forest Investigative Site 1146 | Pittsburgh | Pennsylvania | 15243 | — |
| Forest Investigative Site 1449 | Tipton | Pennsylvania | 16684 | — |
| Forest Investigative Site 1862 | Uniontown | Pennsylvania | 15473 | — |
| Forest Investigative Site 1832 | Cumberland | Rhode Island | 02864 | — |
| Forest Investigative Site 1089 | East Providence | Rhode Island | 02914 | — |
| Forest Investigative Site 2072 | Charleston | South Carolina | 29406 | — |
| Forest Investigative Site 1905 | Charleston | South Carolina | 29407 | — |
| Forest Investigative Site 1802 | Charleston | South Carolina | 29412 | — |
| Forest Investigative Site 1914 | Fort Mill | South Carolina | 29707 | — |
| Forest Investigative Site 1913 | Gaffney | South Carolina | 29340 | — |
| Forest Investigative Site 1121 | Spartanburg | South Carolina | 29303 | — |
| Forest Investigative Site 1957 | Brentwood | Tennessee | 37027 | — |
| Forest Investigative Site 1526 | Fayetteville | Tennessee | 37334 | — |
| Forest Investigative Site 1440 | Arlington | Texas | 76012 | — |
| Forest Investigative Site 1879 | Boerne | Texas | 78006 | — |
| Forest Investigative Site 1861 | Carrollton | Texas | 75007 | — |
| Forest Investigative Site 1816 | Corsicana | Texas | 75110 | — |
| Forest Investigative Site 1890 | Dallas | Texas | 75220 | — |
| Forest Investigative Site 1332 | El Paso | Texas | 79903 | — |
| Forest Investigative Site 2012 | Fort Worth | Texas | 76104 | — |
| Forest Investigative Site 1951 | Houston | Texas | 77070 | — |
| Forest Investigative Site 1091 | McKinney | Texas | 75069 | — |
| Forest Investigative Site 1826 | Plano | Texas | 75001 | — |
| Forest Investigative Site 1895 | San Antonio | Texas | 78212 | — |
| Forest Investigative Site 1936 | Salt Lake City | Utah | 84102 | — |
| Forest Investigative Site 1330 | South Burlington | Vermont | 05403 | — |
| Forest Investigative Site 1945 | Newport News | Virginia | 23606 | — |
| Forest Investigative Site 1404 | Norfolk | Virginia | 23502 | — |
| Forest Investigative Site 1120 | Bellingham | Washington | 98225 | — |
| Forest Investigative Site 1977 | Spokane | Washington | 99202 | — |
| Forest Investigative Site 1878 | Spokane | Washington | 99204 | — |
| Forest Investigative Site 1573 | Spokane | Washington | 99216 | — |
| Forest Investigative Site 0988 | Tacoma | Washington | 98405 | — |
| Forest Investigative Site 1870 | Tacoma | Washington | 98405 | — |
| Forest Investigative Site 1555 | Morgantown | West Virginia | 26505 | — |
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 29 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01572792, 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 21, 2017 · Synced Oct 22, 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 NCT01572792 live on ClinicalTrials.gov.