Chronic Obstructive Pulmonary Disease Clinical Trial
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)
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.
| Status | Completed |
| Enrollment | 909 |
| Est. completion date | June 2013 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Completion of the treatment phase of the lead-in study, LAC-MD-31 - Written informed consent obtained from the patient before the initiation of any study specific procedures - No medical contraindication as judged by the PI - Compliance with LAC-MD-31 study procedures and IP dosing. Exclusion Criteria: - No specific exclusion criteria |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Forest Investigative Site 2253 | Adelaide | South Australia |
| Australia | Forest Investigative Site 1981 | Bedford Park | South Australia |
| Australia | Forest Investigative Site 2250 | Clayton | Victoria |
| Australia | Forest Investigative Site 1990 | Daw Park | South Australia |
| Australia | Forest Investigative Site 1972 | Fitzroy | Victoria |
| Australia | Forest Investigative Site 1986 | Geelong | Victoria |
| Australia | Forest Investigative Site 1991 | New Lambton | New South Wales |
| Australia | Forest Investigative Site 1985 | Parkville | Victoria |
| Australia | Forest Investigative Site 1987 | Redcliffe | Queensland |
| Australia | Forest Investigative Site 2251 | Toorak Gardens | South Australia |
| Australia | Forest Investigative Site 1973 | Woolloongabba | Queensland |
| Canada | Forest Investigative Site 1904 | Langley | British Columbia |
| Canada | Forest Investigative Site 1952 | Montreal | Quebec |
| Canada | Forest Investigative Site 1859 | Quebec | |
| Canada | Forest Investigative Site 1877 | Sarina | Ontario |
| Canada | Forest Investigative Site 1896 | Sarnia | Ontario |
| Canada | Forest Investigative Site 0943 | Saskatoon | Saskatchewan |
| Canada | Forest Investigative Site 1171 | Toronto | Ontario |
| Canada | Forest Investigative Site 2203 | Toronto | Ontario |
| Canada | Forest Investigative Site 905 | Vancouver | British Columbia |
| Canada | Forest Investigative Site 0976 | Winnipeg | Manitoba |
| New Zealand | Forest Investigative Site 1027 | Auckland | |
| New Zealand | Forest Investigative Site 1970 | Christchurch | |
| New Zealand | Forest Investigative Site 1964 | Dunedin | |
| New Zealand | Forest Investigative Site 1967 | Dunedin | |
| New Zealand | Forest Investigative Site 1968 | Hamilton | |
| New Zealand | Forest Investigative Site 1965 | Tauranga | |
| New Zealand | Forest Investigative Site 1980 | Tauranga | |
| New Zealand | Forest Investigative Site 1025 | Wellington | |
| United States | Forest Investigative Site 1949 | Albuquerque | New Mexico |
| United States | Forest Investigative Site 1833 | Altoona | Pennsylvania |
| United States | Forest Investigative Site 1822 | Anaheim | California |
| United States | Forest Investigative Site 1892 | Ann Arbor | Michigan |
| United States | Forest Investigative Site 1827 | Anniston | Alabama |
| United States | Forest Investigative Site 1440 | Arlington | Texas |
| United States | Forest Investigative Site 1920 | Athens | Alabama |
| United States | Forest Investigative Site 1900 | Atlanta | Georgia |
| United States | Forest Investigative Site 0987 | Austell | Georgia |
| United States | Forest Investigative Site 1924 | Baltimore | Maryland |
| United States | Forest Investigative Site 1814 | Bangor | Maine |
| United States | Forest Investigative Site 1821 | Bay Pines | Florida |
| United States | Forest Investigative Site 1609 | Bellevue | Nebraska |
| United States | Forest Investigative Site 1120 | Bellingham | Washington |
| United States | Forest Investigative Site 1889 | Bend | Oregon |
| United States | Forest Investigative Site 1162 | Birmingham | Alabama |
| United States | Forest Investigative Site 1493 | Birmingham | Alabama |
| United States | Forest Investigative Site 1937 | Birmingham | Alabama |
| United States | Forest Investigative Site 1879 | Boerne | Texas |
| United States | Forest Investigative Site 2033 | Bowling Green | Kentucky |
| United States | Forest Investigative Site 1831 | Bozeman | Montana |
| United States | Forest Investigative Site 1154 | Brandon | Florida |
| United States | Forest Investigative Site 1944 | Brandon | Florida |
| United States | Forest Investigative Site 1957 | Brentwood | Tennessee |
| United States | Forest Investigative Site 1483 | Buena Park | California |
| United States | Forest Investigative Site 1891 | Cadiz | Ohio |
| United States | Forest Investigative Site 1134 | Canton | Ohio |
| United States | Forest Investigative Site 1828 | Canton | Georgia |
| United States | Forest Investigative Site 1861 | Carrollton | Texas |
| United States | Forest Investigative Site 1802 | Charleston | South Carolina |
| United States | Forest Investigative Site 1905 | Charleston | South Carolina |
| United States | Forest Investigative Site 2072 | Charleston | South Carolina |
| United States | Forest Investigative Site 1392 | Charlotte | North Carolina |
| United States | Forest Investigative Site 1559 | Cherry Hill | New Jersey |
| United States | Forest Investigative Site 1806 | Cincinnati | Ohio |
| United States | Forest Investigative Site 1885 | Cincinnati | Ohio |
| United States | Forest Investigative Site 1903 | Cincinnati | Ohio |
| United States | Forest Investigative Site 2028 | Cincinnati | Ohio |
| United States | Forest Investigative Site 1152 | Clearwater | Florida |
| United States | Forest Investigative Site 1364 | Clearwater | Florida |
| United States | Forest Investigative Site 1875 | Clearwater | Florida |
| United States | Forest Investigative Site 0679 | Coeur d Alene | Idaho |
| United States | Forest Investigative Site 1361 | Columbus | Ohio |
| United States | Forest Investigative Site 1433 | Columbus | Ohio |
| United States | Forest Investigative Site 1816 | Corsicana | Texas |
| United States | Forest Investigative Site 1811 | Covington | Florida |
| United States | Forest Investigative Site 1832 | Cumberland | Rhode Island |
| United States | Forest Investigative Site 1890 | Dallas | Texas |
| United States | Forest Investigative Site 0670 | DeLand | Florida |
| United States | Forest Investigative Site 1820 | Downington | Pennsylvania |
| United States | Forest Investigative Site 1858 | Eagle | Idaho |
| United States | Forest Investigative Site 1089 | East Providence | Rhode Island |
| United States | Forest Investigative Site 1516 | Edgewater | Florida |
| United States | Forest Investigative Site 1128 | Edina | Minnesota |
| United States | Forest Investigative Site 1332 | El Paso | Texas |
| United States | Forest Investigative Site 2035 | Elizabeth City | North Carolina |
| United States | Forest Investigative Site 1423 | Erie | Pennsylvania |
| United States | Forest Investigative Site 1570 | Fall River | Massachusetts |
| United States | Forest Investigative Site 1852 | Fall River | Massachusetts |
| United States | Forest Investigative Site 1526 | Fayetteville | Tennessee |
| United States | Forest Investigative Site 0990 | Fort Lauderdale | Florida |
| United States | Forest Investigative Site 1914 | Fort Mill | South Carolina |
| United States | Forest Investigative Site 2085 | Fort Mitchell | Kentucky |
| United States | Forest Investigative Site 2012 | Fort Worth | Texas |
| United States | Forest Investigative Site 1948 | Fremont | Nebraska |
| United States | Forest Investigative Site 1156 | Fresno | California |
| United States | Forest Investigative Site 1527 | Fridley | Minnesota |
| United States | Forest Investigative Site 1913 | Gaffney | South Carolina |
| United States | Forest Investigative Site 0909 | Glendale | Arizona |
| United States | Forest Investigative Site 1380 | Golden | Colorado |
| United States | Forest Investigative Site 1151 | Great Neck | New York |
| United States | Forest Investigative Site 1824 | Gulf Shores | Alabama |
| United States | Forest Investigative Site 1923 | Hackensack | New Jersey |
| United States | Forest Investigative Site 1807 | Henderson | Nevada |
| United States | Forest Investigative Site 1513 | Hialeah | Florida |
| United States | Forest Investigative Site 1854 | Hialeah | Florida |
| United States | Forest Investigative Site 1366 | High Point | North Carolina |
| United States | Forest Investigative Site 1882 | Hollywood | Florida |
| United States | Forest Investigative Site 1951 | Houston | Texas |
| United States | Forest Investigative Site 1543 | Jacksonville | Florida |
| United States | Forest Investigative Site 2088 | Jasper | Alabama |
| United States | Forest Investigative Site 1602 | Kansas City | Missouri |
| United States | Forest Investigative Site 1416 | Kissimmee | Florida |
| United States | Forest Investigative Site 1899 | Langhorne | Pennsylvania |
| United States | Forest Investigative Site 1489 | Larchmont | New York |
| United States | Forest Investigative Site 1562 | Las Vegas | Nevada |
| United States | Forest Investigative Site 1834 | Las Vegas | Nevada |
| United States | Forest Investigative Site 0539 | Lexington | Kentucky |
| United States | Forest Investigative Site 1815 | Lincoln | Nebraska |
| United States | Forest Investigative Site 1871 | Lincoln | California |
| United States | Forest Investigative Site 1873 | Los Angeles | California |
| United States | Forest Investigative Site 1478 | Louisville | Kentucky |
| United States | Forest Investigative Site 1830 | Marietta | Georgia |
| United States | Forest Investigative Site 1091 | McKinney | Texas |
| United States | Forest Investigative Site 2043 | Medford | Oregon |
| United States | Forest Investigative Site 1167 | Melbourne | Florida |
| United States | Forest Investigative Site 1432 | Miami | Florida |
| United States | Forest Investigative Site 1124 | Minneapolis | Minnesota |
| United States | Forest Investigative Site 2041 | Minneapolis | Minnesota |
| United States | Forest Investigative Site 1400 | Missoula | Montana |
| United States | Forest Investigative Site 1555 | Morgantown | West Virginia |
| United States | Forest Investigative Site 1587 | N. Chesterfield | Missouri |
| United States | Forest Investigative Site 1808 | N. Miami | Florida |
| United States | Forest Investigative Site 1819 | Naples | Florida |
| United States | Forest Investigative Site 1430 | New Orleans | Louisiana |
| United States | Forest Investigative Site 1425 | New York | New York |
| United States | Forest Investigative Site 550 | New York | New York |
| United States | Forest Investigative Site 1945 | Newport News | Virginia |
| United States | Forest Investigative Site 1431 | No. Dartmouth | Massachusetts |
| United States | Forest Investigative Site 1404 | Norfolk | Virginia |
| United States | Forest Investigative Site 1095 | Normal | Illinois |
| United States | Forest Investigative Site 1912 | Normal | Illinois |
| United States | Forest Investigative Site 1915 | Oklahoma City | Oklahoma |
| United States | Forest Investigative Site 1950 | Oldsmar | Florida |
| United States | Forest Investigative Site 1884 | Olive Branch | Mississippi |
| United States | Forest Investigative Site 1363 | Omaha | Nebraska |
| United States | Forest Investigative Site 1804 | Omaha | Nebraska |
| United States | Forest Investigative Site 1907 | Omaha | Nebraska |
| United States | Forest Investigative Site 1908 | Omaha | Nebraska |
| United States | Forest Investigative Site 1911 | Omaha | Nebraska |
| United States | Forest Investigative Site 1812 | Opelousas | Louisiana |
| United States | Forest Investigative Site 1145 | Ormond Beach | Florida |
| United States | Forest Investigative Site 1519 | Owensboro | Kentucky |
| United States | Forest Investigative Site 1094 | Panama City | Florida |
| United States | Forest Investigative Site 1803 | Pembroke Pines | Florida |
| United States | Forest Investigative Site 0974 | Pensacola | Florida |
| United States | Forest Investigative Site 1443 | Philadelphia | Pennsylvania |
| United States | Forest Investigative Site 1379 | Phoenix | Arizona |
| United States | Forest Investigative Site 1863 | Phoenixville | Pennsylvania |
| United States | Forest Investigative Site 1146 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 1826 | Plano | Texas |
| United States | Forest Investigative Site 1619 | Plymouth | Minnesota |
| United States | Forest Investigative Site 1137 | Pueblo | Colorado |
| United States | Forest Investigative Site 1153 | Raleigh | North Carolina |
| United States | Forest Investigative Site 2051 | River Forest | Illinois |
| United States | Forest Investigative Site 2064 | Riverside | California |
| United States | Forest Investigative Site 1118 | Rochester | Minnesota |
| United States | Forest Investigative Site 2098 | Rochester | New York |
| United States | Forest Investigative Site 1427 | Sacramento | California |
| United States | Forest Investigative Site 1866 | Sacramento | California |
| United States | Forest Investigative Site 1823 | Salisbury | North Carolina |
| United States | Forest Investigative Site 1936 | Salt Lake City | Utah |
| United States | Forest Investigative Site 1895 | San Antonio | Texas |
| United States | Forest Investigative Site 1125 | San Diego | California |
| United States | Forest Investigative Site 2009 | San Diego | California |
| United States | Forest Investigative Site 1817 | Sarasota | Florida |
| United States | Forest Investigative Site 1918 | Scottsboro | Alabama |
| United States | Forest Investigative Site 1330 | South Burlington | Vermont |
| United States | Forest Investigative Site 1121 | Spartanburg | South Carolina |
| United States | Forest Investigative Site 1573 | Spokane | Washington |
| United States | Forest Investigative Site 1878 | Spokane | Washington |
| United States | Forest Investigative Site 1977 | Spokane | Washington |
| United States | Forest Investigative Site 1856 | Springfield | Missouri |
| United States | Forest Investigative Site 1867 | Springfield | Missouri |
| United States | Forest Investigative Site 2079 | St. Charles | Missouri |
| United States | Forest Investigative Site 1399 | St. Louis | Missouri |
| United States | Forest Investigative Site 1599 | St. Louis | Missouri |
| United States | Forest Investigative Site 1874 | St. Petersburg | Florida |
| United States | Forest Investigative Site 1342 | Stevensville | Michigan |
| United States | Forest Investigative Site 2090 | Sylvania | Ohio |
| United States | Forest Investigative Site 0988 | Tacoma | Washington |
| United States | Forest Investigative Site 1870 | Tacoma | Washington |
| United States | Forest Investigative Site 2082 | Tamarac | Florida |
| United States | Forest Investigative Site 2047 | Tampa | Florida |
| United States | Forest Investigative Site 2053 | Tampa | Florida |
| United States | Forest Investigative Site 1449 | Tipton | Pennsylvania |
| United States | Forest Investigative Site 1530 | Toledo | Ohio |
| United States | Forest Investigative Site 1374 | Torrance | California |
| United States | Forest Investigative Site 1487 | Troy | Michigan |
| United States | Forest Investigative Site 1813 | Tustin | California |
| United States | Forest Investigative Site 1862 | Uniontown | Pennsylvania |
| United States | Forest Investigative Site 1883 | Vista | California |
| United States | Forest Investigative Site 1976 | Waterbury | Connecticut |
| United States | Forest Investigative Site 1327 | Wheat Ridge | Colorado |
| United States | Forest Investigative Site 1872 | Wheaton | Maryland |
| United States | Forest Investigative Site 1185 | Winter Park | Florida |
| United States | Forest Investigative Site 1860 | Winter Park | Florida |
| United States | Forest Investigative Site 2089 | Woodstock | Georgia |
| United States | Forest Investigative Site 1393 | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Australia, Canada, New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and tolerability | Adverse Events, Clinical Laboratory Parameters, Vital Sign Measurement, and electrocardiogram parameters | 28 weeks | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
| Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
| Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
| Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
| Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
| Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
| Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
| Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
| Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
| Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
| Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
| Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
| Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
| Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|