Chronic Obstructive Pulmonary Disease Clinical Trial
— LACOfficial title:
A Long-Term, Randomized, Study of the Safety and Tolerability of a Fixed-Dose Combination of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)
| Verified date | April 2013 |
| Source | Forest Laboratories |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).
| Status | Completed |
| Enrollment | 590 |
| Est. completion date | April 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
Inclusion Criteria: - Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years - A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction. Exclusion Criteria: - Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1 - Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1. - Patients with any clinically significant respiratory conditions other than COPD - Clinical history that suggests that the patient has asthma as opposed to COPD - Chronic use of oxygen therapy = 15 hours/day - Patients with clinically significant cardiovascular conditions - Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis - Patients with a history of hypersensitivity reaction to inhaled anticholinergics, - Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above - Current diagnosis of cancer other than basal or squamous cell skin cancer |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Forest Investigative Site 1480 | Abingdon | Virginia |
| United States | Forest Investigative Site 1579 | Alexandria | Virginia |
| United States | Forest Investigative Site 1440 | Arlington | Texas |
| United States | Forest Investigative Site 1612 | Ashland | Oregon |
| United States | Forest Investigative Site 0980 | Atlanta | Georgia |
| United States | Forest Investigative Site 1567 | Atlanta | Georgia |
| United States | Forest Investigative Site 1851 | Atlanta | Georgia |
| United States | Forest Investigative Site 1566 | Auburn | Maine |
| United States | Forest Investigative Site 1954 | Austin | Texas |
| United States | Forest Investigative Site 1333 | Baltimore | Maryland |
| United States | Forest Investigative Site 1574 | Beaver | Pennsylvania |
| United States | Forest Investigative Site 1577 | Beaver | Pennsylvania |
| United States | Forest Investigative Site 1609 | Bellevue | Nebraska |
| United States | Forest Investigative Site 1126 | Bethlehem | Pennsylvania |
| United States | Forest Investigative Site 1162 | Birmingham | Alabama |
| United States | Forest Investigative Site 1493 | Birmingham | Alabama |
| United States | Forest Investigative Site 1620 | Birmingham | Alabama |
| United States | Forest Investigative Site 1597 | Boulder | Colorado |
| 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 1558 | Brick | New Jersey |
| United States | Forest Investigative Site 0972 | Brooklyn | New York |
| United States | Forest Investigative Site 1134 | Canton | Ohio |
| United States | Forest Investigative Site 1613 | Chandler | Arizona |
| United States | Forest Investigative Site 2072 | Charleston | South Carolina |
| United States | Forest Investigative Site 1559 | Cherry Hill | New Jersey |
| United States | Forest Investigative Site 1587 | Chesterfield | Missouri |
| United States | Forest Investigative Site 1594 | Cincinnati | Ohio |
| United States | Forest Investigative Site 2028 | Cincinnati | Ohio |
| United States | Forest Investigative Site 1152 | Clearwater | Florida |
| United States | Forest Investigative Site 1137 | Colorado Springs | Colorado |
| United States | Forest Investigative Site 1622 | Columbia | Maryland |
| United States | Forest Investigative Site 1575 | Corvallis | Oregon |
| United States | Forest Investigative Site 1549 | Council Bluffs | Iowa |
| United States | Forest Investigative Site 2085 | Crescent Springs | Kentucky |
| United States | Forest Investigative Site 1155 | Dallas | Texas |
| United States | Forest Investigative Site 1328 | Dallas | Texas |
| United States | Forest Investigative Site 1617 | Debary | Florida |
| United States | Forest Investigative Site 1959 | Debary | Florida |
| United States | Forest Investigative Site 0892 | Denver | Colorado |
| United States | Forest Investigative Site 1568 | Easley | South Carolina |
| United States | Forest Investigative Site 1516 | Edgewater | Florida |
| United States | Forest Investigative Site 1332 | El Paso | Texas |
| United States | Forest Investigative Site 1547 | Encinitas | California |
| United States | Forest Investigative Site 1423 | Erie | Pennsylvania |
| United States | Forest Investigative Site 1081 | Eugene | Oregon |
| United States | Forest Investigative Site 1576 | Evansville | Indiana |
| United States | Forest Investigative Site 1570 | Fall River | Massachusetts |
| United States | Forest Investigative Site 2037 | Fort Collins | Colorado |
| United States | Forest Investigative Site 1596 | Fort Smith | Arkansas |
| United States | Forest Investigative Site 2012 | Fort Worth | Texas |
| United States | Forest Investigative Site 1527 | Fridley | Minnesota |
| United States | Forest Investigative Site 1506 | Greenville | South Carolina |
| United States | Forest Investigative Site 1601 | Greer | South Carolina |
| United States | Forest Investigative Site 1546 | Haverhill | Massachusetts |
| United States | Forest Investigative Site 1504 | Hershey | Pennsylvania |
| United States | Forest Investigative Site 1403 | Hollywood | Florida |
| United States | Forest Investigative Site 1572 | Jefferson City | Missouri |
| United States | Forest Investigative Site 1144 | Johnston | Rhode Island |
| United States | Forest Investigative Site 1902 | Killeen | Texas |
| United States | Forest Investigative Site 2024 | Lafayette | Louisiana |
| United States | Forest Investigative Site 1088 | Lakewood | California |
| United States | Forest Investigative Site 1562 | Las Vegas | Nevada |
| United States | Forest Investigative Site 1607 | Lawrenceville | Georgia |
| United States | Forest Investigative Site 1616 | Lincoln | Nebraska |
| United States | Forest Investigative Site 1624 | Los Angeles | California |
| United States | Forest Investigative Site 1927 | Los Angeles | California |
| United States | Forest Investigative Site 1336 | Louisville | Kentucky |
| United States | Forest Investigative Site 1600 | Magna | Utah |
| United States | Forest Investigative Site 1541 | Marion | Ohio |
| United States | Forest Investigative Site 1124 | Minneapolis | Minnesota |
| United States | Forest Investigative Site 1400 | Missoula | Montana |
| United States | Forest Investigative Site 1127 | Mobile | Alabama |
| United States | Forest Investigative Site 1430 | New Orleans | Louisiana |
| United States | Forest Investigative Site 1163 | New York | New York |
| United States | Forest Investigative Site 1425 | New York | New York |
| United States | Forest Investigative Site 1554 | Newburgh | New York |
| United States | Forest Investigative Site 1029 | North Dartmouth | Massachusetts |
| United States | Forest Investigative Site 1589 | Norwalk | Connecticut |
| United States | Forest Investigative Site 1409 | O'Fallon | Illinois |
| United States | Forest Investigative Site 1394 | Ocean | New Jersey |
| United States | Forest Investigative Site 1615 | Omaha | Nebraska |
| United States | Forest Investigative Site 1556 | Orlando | Florida |
| United States | Forest Investigative Site 1542 | Ormond Beach | Florida |
| United States | Forest Investigative Site 1388 | Paramount | California |
| United States | Forest Investigative Site 0974 | Pensacola | Florida |
| United States | Forest Investigative Site 1623 | Peoria | Arizona |
| United States | Forest Investigative Site 1379 | Phoenix | Arizona |
| United States | Forest Investigative Site 1571 | Phoenix | Arizona |
| United States | Forest Investigative Site 1581 | Phoenix | Arizona |
| United States | Forest Investigative Site 1582 | Phoenix | Arizona |
| United States | Forest Investigative Site 1146 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 1548 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 1560 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 1569 | Pittsburgh | Pennsylvania |
| United States | Forest Investigative Site 1619 | Plymouth | Minnesota |
| United States | Forest Investigative Site 1552 | Portland | Oregon |
| United States | Forest Investigative Site 1580 | Portland | Oregon |
| United States | Forest Investigative Site 1557 | Raleigh | North Carolina |
| United States | Forest Investigative Site 1365 | Rapid City | South Dakota |
| United States | Forest Investigative Site 2051 | River Forest | Illinois |
| United States | Forest Investigative Site 1610 | Rochester | New Hampshire |
| United States | Forest Investigative Site 1498 | San Antonio | Texas |
| United States | Forest Investigative Site 1614 | San Antonio | Texas |
| United States | Forest Investigative Site 1906 | San Antonio | Texas |
| United States | Forest Investigative Site 2004 | San Antonio | Texas |
| United States | Forest Investigative Site 1503 | San Diego | California |
| United States | Forest Investigative Site 1588 | Shelby | North Carolina |
| United States | Forest Investigative Site 0900 | Spartanburg | South Carolina |
| United States | Forest Investigative Site 1142 | Spokane | Washington |
| United States | Forest Investigative Site 1573 | Spokane | Washington |
| United States | Forest Investigative Site 1604 | Springfield | Illinois |
| United States | Forest Investigative Site 1399 | St. Louis | Missouri |
| United States | Forest Investigative Site 1599 | St. Louis | Missouri |
| United States | Forest Investigative Site 1598 | Stamford | Connecticut |
| United States | Forest Investigative Site 2084 | Summit | New Jersey |
| United States | Forest Investigative Site 1360 | Sunset | Louisiana |
| United States | Forest Investigative Site 1563 | Syracuse | New York |
| United States | Forest Investigative Site 2047 | 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 1590 | Towson | Maryland |
| United States | Forest Investigative Site 1605 | Traverse City | Michigan |
| United States | Forest Investigative Site 1450 | Union | South Carolina |
| United States | Forest Investigative Site 1564 | Uniontown | Pennsylvania |
| United States | Forest Investigative Site 1565 | Venice | Florida |
| United States | Forest Investigative Site 1331 | Vista | California |
| United States | Forest Investigative Site 2039 | Walnut Creek | California |
| United States | Forest Investigative Site 1327 | Wheat Ridge | Colorado |
| United States | Forest Investigative Site 2045 | Wheat Ridge | Colorado |
| United States | Forest Investigative Site 1553 | Wilmington | North Carolina |
| United States | Forest Investigative Site 1550 | Winston-Salem | North Carolina |
| United States | Forest Investigative Site 1595 | Worcestor | Massachusetts |
| United States | Forest Investigative Site 1393 | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Forest Laboratories | Almirall, S.A. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse event (AE) recording | Number of patients to experience a Treatment Emergent Adverse Event (TEAE) | From Baseline (Week 0) to Week 52 | Yes |
| Primary | Vital Signs | Number of patients to experience a potentially clinically significant (PCS) change in pulse rate, systolic and diastolic blood pressure, body temperature or body weight. | From Baseline (Week 0) to Week 52 | Yes |
| Primary | Electrocardiograms (ECGs) | Number of patients to experience potentially clinically significant changes in ECG from Baseline. | From Baseline (Week 0) to Week 52 | Yes |
| Primary | Clinical Laboratory Measures | Number of patients to experience a potentially clinically significant (PCS) change in clinical laboratory values for Hematology, Chemistry, Urinalysis or Theophylline. | From Baseline (Week 0) to Week 52 | Yes |
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