Chronic Obstructive Pulmonary Disease Clinical Trial
— ASCENT COPDOfficial title:
Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)
Verified date | November 2018 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
Status | Completed |
Enrollment | 3635 |
Est. completion date | September 21, 2017 |
Est. primary completion date | September 21, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 130 Years |
Eligibility |
Inclusion Criteria: - 1. Male or female outpatients = 40 years of age - 2. Current or former cigarette smokers with a smoking history of at least 10 pack-years - 3. A diagnosis of stable, moderate to very severe COPD (GOLD, 2015) with a post-bronchodilator FEV < 80% FEV1/forced vital capacity (FVC) ratio < 70% - 4. Must have at least one of the following 4 criteria: 1. Documented cerebrovascular disease (stroke or transient ischemic attack, carotid stenosis) 2. Documented coronary artery disease (angina, MI, angioplasty/stent/bypass) 3. Documented peripheral vascular disease or history of claudication 4. At least 2 of the following atherothrombotic risk factors as determined by the PI: 1. Male = 65 years or female = 70 years 2. Diabetes 3. Dyslipidemia 4. Hypertension 5. Waist circumference inches males = 40 in or in females = 38 inches 6. Evidence of renal dysfunction (eGFR < 60) and microalbuminuria (eGFR is based on modification of diet in renal disease [MDRD] equation, microalbuminuria is defined as = 30-300 mcg/mg creatinine on a spot urine or =30 mg creatinine on a 24hr urine test) - 5. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II) - 6. Able to perform pulmonary function test (PFT) maneuvers and follow study procedures - 7. Women of childbearing potential must have a negative serum ß-human chorionic gonadotropin (HCG) pregnancy test at Visit 1A and be practicing medically acceptable method of contraception. Otherwise, female patients should be at least 1 year postmenopausal, surgically sterile (defined as having a hysterectomy or tubal ligation). - 8. Should understand study procedures and be willing to participate in the study as indicated by signing the ICF Exclusion Criteria: - 1. Significant diseases other than COPD or cardiovascular disease (e.g., metastatic cancer) which, in the opinion of the PI, may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study - 2. Unstable or life threatening cardiovascular disease or COPD as determined by the PI - 3. Patients with comorbid lung disease such as asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease - 4. Planned lung transplant or lung volume reduction surgery - 5. Currently treated with a combination of LAMA and LABA/ICS therapy. - 6. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within 5 years prior to screening. Patients with treated basal cell and squamous cell (skin) carcinoma are allowed - 7. Respiratory infection or COPD exacerbation at Screening and/or within 4 weeks prior to screening - 8. Uncontrolled infection resulting from human immunodeficiency virus (HIV) and/or active hepatitis - 9. Reported history of drug or alcohol abuse within the past 12 months - 10. History of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm) - 11. History of acute urinary retention, treatment refractory benign prostatic hyperplasia (BPH), bladder neck obstruction, or narrow-angle glaucoma (Note: Patients with controlled, stable BPH are not excluded) - 12. Patients unable to use a multidose DPI or a pressurized metered-dose inhaler - 13. Treatment with any other investigational drug within 30 days (or 6 half-lives, whichever is longer) before Visit 1A - 14. Women who are pregnant or breastfeeding - 15. Use of any prohibited medication listed in Appendix II - 16. Employee or immediate relative of an employee of AstraZeneca, any of its affiliates or partners, or the study center |
Country | Name | City | State |
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Canada | Research Site | Ajax | Ontario |
Canada | Research Site | Bridgewater | Nova Scotia |
Canada | Research Site | Burlington | Ontario |
Canada | Research Site | Cornwall | Ontario |
Canada | Research Site | Dorchester | Ontario |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Edmonton | Alberta |
Canada | Research Site | Halifax | Nova Scotia |
Canada | Research Site | Hamilton | Ontario |
Canada | Research Site | Kamloops | British Columbia |
Canada | Research Site | Kelowna | British Columbia |
Canada | Research Site | Langley | British Columbia |
Canada | Research Site | London | Ontario |
Canada | Research Site | London | Ontario |
Canada | Research Site | Longueuil | Quebec |
Canada | Research Site | Montreal | Quebec |
Canada | Research Site | Newmarket | Ontario |
Canada | Research Site | Penticton | British Columbia |
Canada | Research Site | Quebec | |
Canada | Research Site | Quebec | |
Canada | Research Site | Saskatoon | Saskatchewan |
Canada | Research Site | St Charles Borromee | Quebec |
Canada | Research Site | St. John's | Newfoundland and Labrador |
Canada | Research Site | Sudbury | Ontario |
Canada | Research Site | Sudbury | Ontario |
Canada | Research Site | Thorold | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Toronto | Ontario |
Canada | Research Site | Waterloo | Ontario |
Canada | Research Site | West Vancouver | British Columbia |
Canada | Research Site | Windsor | Ontario |
Canada | Research Site | Windsor | Ontario |
Canada | Research Site | Winnipeg | Manitoba |
United States | Research Site | Abingdon | Virginia |
United States | Research Site | Akron | Ohio |
United States | Research Site | Altoona | Pennsylvania |
United States | Research Site | Amarillo | Texas |
United States | Research Site | Ames | Iowa |
United States | Research Site | Anderson | South Carolina |
United States | Research Site | Arlington | Texas |
United States | Research Site | Asheville | North Carolina |
United States | Research Site | Athens | Tennessee |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Atlanta | Georgia |
United States | Research Site | Austin | Texas |
United States | Research Site | Avon | Indiana |
United States | Research Site | Bakersfield | California |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Baltimore | Maryland |
United States | Research Site | Bangor | Maine |
United States | Research Site | Bay Pines | Florida |
United States | Research Site | Beaumont | Texas |
United States | Research Site | Beaver | Pennsylvania |
United States | Research Site | Belle Vernon | Pennsylvania |
United States | Research Site | Bellevue | Nebraska |
United States | Research Site | Bellevue | Washington |
United States | Research Site | Bellingham | Washington |
United States | Research Site | Belvidere | New Jersey |
United States | Research Site | Bensalem | Pennsylvania |
United States | Research Site | Biddeford | Maine |
United States | Research Site | Bingham Farms | Michigan |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Birmingham | Alabama |
United States | Research Site | Blue Ridge | Georgia |
United States | Research Site | Boerne | Texas |
United States | Research Site | Boulder | Colorado |
United States | Research Site | Bowling Green | Kentucky |
United States | Research Site | Boynton Beach | Florida |
United States | Research Site | Brandon | Florida |
United States | Research Site | Bridgeton | Missouri |
United States | Research Site | Bridgewater | New Jersey |
United States | Research Site | Bristol | Connecticut |
United States | Research Site | Bronx | New York |
United States | Research Site | Brooklyn | New York |
United States | Research Site | Buckley | Michigan |
United States | Research Site | Buffalo | New York |
United States | Research Site | Burlington | North Carolina |
United States | Research Site | Calabash | North Carolina |
United States | Research Site | Canton | Ohio |
United States | Research Site | Carnegie | Pennsylvania |
United States | Research Site | Caro | Michigan |
United States | Research Site | Carrollton | Texas |
United States | Research Site | Centennial | Colorado |
United States | Research Site | Champaign | Illinois |
United States | Research Site | Chandler | Arizona |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Charleston | South Carolina |
United States | Research Site | Charleston | West Virginia |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Charlotte | North Carolina |
United States | Research Site | Chattanooga | Tennessee |
United States | Research Site | Chesterfield | Michigan |
United States | Research Site | Chesterfield | Missouri |
United States | Research Site | Chicago | Illinois |
United States | Research Site | Cincinnati | Ohio |
United States | Research Site | Clairton | Pennsylvania |
United States | Research Site | Clearwater | Florida |
United States | Research Site | Clearwater | Florida |
United States | Research Site | Colorado Springs | Colorado |
United States | Research Site | Colorado Springs | Colorado |
United States | Research Site | Columbia | Missouri |
United States | Research Site | Columbia | South Carolina |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Columbus | Georgia |
United States | Research Site | Corsicana | Texas |
United States | Research Site | Council Bluffs | Iowa |
United States | Research Site | Covington | Louisiana |
United States | Research Site | Crowley | Louisiana |
United States | Research Site | Cypress | Texas |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dallas | Texas |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Dayton | Ohio |
United States | Research Site | Daytona Beach | Florida |
United States | Research Site | DeBary | Florida |
United States | Research Site | DeLand | Florida |
United States | Research Site | Delaware | Ohio |
United States | Research Site | Dickinson | Texas |
United States | Research Site | Doral | Florida |
United States | Research Site | Doral | Florida |
United States | Research Site | Doral | Florida |
United States | Research Site | Downingtown | Pennsylvania |
United States | Research Site | Dublin | Ohio |
United States | Research Site | Duluth | Georgia |
United States | Research Site | Duncanville | Texas |
United States | Research Site | Eagle | Idaho |
United States | Research Site | Easley | South Carolina |
United States | Research Site | East Brunswick | New Jersey |
United States | Research Site | East Providence | Rhode Island |
United States | Research Site | Elizabeth | New Jersey |
United States | Research Site | Elkridge | Maryland |
United States | Research Site | Elwood | Indiana |
United States | Research Site | Encinitas | California |
United States | Research Site | Erie | Pennsylvania |
United States | Research Site | Escondido | California |
United States | Research Site | Eunice | Louisiana |
United States | Research Site | Eustis | Florida |
United States | Research Site | Evanston | Illinois |
United States | Research Site | Evansville | Indiana |
United States | Research Site | Evansville | Indiana |
United States | Research Site | Everett | Washington |
United States | Research Site | Fall River | Massachusetts |
United States | Research Site | Fargo | North Dakota |
United States | Research Site | Farmington Hills | Michigan |
United States | Research Site | Fayetteville | Tennessee |
United States | Research Site | Feasterville-Trevose | Pennsylvania |
United States | Research Site | Flint | Michigan |
United States | Research Site | Florence | Alabama |
United States | Research Site | Foley | Alabama |
United States | Research Site | Fort Worth | Texas |
United States | Research Site | Fort Worth | Texas |
United States | Research Site | Franklin | Tennessee |
United States | Research Site | Fremont | Nebraska |
United States | Research Site | Fresno | California |
United States | Research Site | Gaffney | South Carolina |
United States | Research Site | Gaffney | South Carolina |
United States | Research Site | Gainesville | Florida |
United States | Research Site | Gastonia | North Carolina |
United States | Research Site | Georgetown | Texas |
United States | Research Site | Gillespie | Illinois |
United States | Research Site | Glendale | Arizona |
United States | Research Site | Gold River | California |
United States | Research Site | Golden | Colorado |
United States | Research Site | Grand Island | Nebraska |
United States | Research Site | Greensboro | North Carolina |
United States | Research Site | Greenville | North Carolina |
United States | Research Site | Greenville | South Carolina |
United States | Research Site | Greenville | South Carolina |
United States | Research Site | Greer | South Carolina |
United States | Research Site | Haddon Heights | New Jersey |
United States | Research Site | Hayden Lake | Idaho |
United States | Research Site | Hendersonville | North Carolina |
United States | Research Site | Hendersonville | Tennessee |
United States | Research Site | Hialeah | Florida |
United States | Research Site | Hialeah | Florida |
United States | Research Site | Hialeah | Florida |
United States | Research Site | High Point | North Carolina |
United States | Research Site | Hodges | South Carolina |
United States | Research Site | Hollywood | Florida |
United States | Research Site | Hollywood | Florida |
United States | Research Site | Homestead | Florida |
United States | Research Site | Hopewell Jct | New York |
United States | Research Site | Hot Springs | Arkansas |
United States | Research Site | Houston | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Houston | Texas |
United States | Research Site | Huntersville | North Carolina |
United States | Research Site | Huntington Beach | California |
United States | Research Site | Huntsville | Alabama |
United States | Research Site | Idaho Falls | Idaho |
United States | Research Site | Indian Land | South Carolina |
United States | Research Site | Iowa City | Iowa |
United States | Research Site | Irving | Texas |
United States | Research Site | Jacksonville | Florida |
United States | Research Site | Jamaica | New York |
United States | Research Site | Jasper | Alabama |
United States | Research Site | Jefferson Hills | Pennsylvania |
United States | Research Site | Johns Creek | Georgia |
United States | Research Site | Jupiter | Florida |
United States | Research Site | Kansas City | Missouri |
United States | Research Site | Kansas City | Missouri |
United States | Research Site | Kettering | Ohio |
United States | Research Site | Kissimmee | Florida |
United States | Research Site | Kissimmee | Florida |
United States | Research Site | Knoxville | Tennessee |
United States | Research Site | La Mirada | California |
United States | Research Site | Laguna Hills | California |
United States | Research Site | Lake Charles | Louisiana |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Las Vegas | Nevada |
United States | Research Site | Lawrenceville | Georgia |
United States | Research Site | Leesburg | Florida |
United States | Research Site | Lenexa | Kansas |
United States | Research Site | Lenoir | North Carolina |
United States | Research Site | Levittown | Pennsylvania |
United States | Research Site | Lewisburg | West Virginia |
United States | Research Site | Lexington | Kentucky |
United States | Research Site | Lincoln | Nebraska |
United States | Research Site | Lincoln | Nebraska |
United States | Research Site | Lincoln | California |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Little Rock | Arkansas |
United States | Research Site | Loma Linda | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Los Angeles | California |
United States | Research Site | Louisville | Kentucky |
United States | Research Site | Louisville | Kentucky |
United States | Research Site | Loxahatchee Groves | Florida |
United States | Research Site | Madisonville | Kentucky |
United States | Research Site | Maitland | Florida |
United States | Research Site | Manassas | Virginia |
United States | Research Site | Marietta | Georgia |
United States | Research Site | Marshall | Louisiana |
United States | Research Site | Maumee | Ohio |
United States | Research Site | Melbourne | Florida |
United States | Research Site | Melrose Park | Illinois |
United States | Research Site | Meridian | Idaho |
United States | Research Site | Meridian | Idaho |
United States | Research Site | Mesa | Arizona |
United States | Research Site | Metairie | Louisiana |
United States | Research Site | Methuen | Massachusetts |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami | Florida |
United States | Research Site | Miami Beach | Florida |
United States | Research Site | Michigan City | Indiana |
United States | Research Site | Midvale | Utah |
United States | Research Site | Minneapolis | Minnesota |
United States | Research Site | Missoula | Montana |
United States | Research Site | Mobile | Alabama |
United States | Research Site | Monroe | North Carolina |
United States | Research Site | Monroe | North Carolina |
United States | Research Site | Mooresville | North Carolina |
United States | Research Site | Morgantown | West Virginia |
United States | Research Site | Morton | Illinois |
United States | Research Site | Mount Pleasant | South Carolina |
United States | Research Site | Muncie | Indiana |
United States | Research Site | Muncie | Indiana |
United States | Research Site | Murray | Utah |
United States | Research Site | Myrtle Beach | South Carolina |
United States | Research Site | Naples | Florida |
United States | Research Site | New Bern | North Carolina |
United States | Research Site | New Hyde Park | New York |
United States | Research Site | New Orleans | Louisiana |
United States | Research Site | New Port Richey | Florida |
United States | Research Site | New York | New York |
United States | Research Site | New York | New York |
United States | Research Site | Norcross | Georgia |
United States | Research Site | Normal | Illinois |
United States | Research Site | Norman | Oklahoma |
United States | Research Site | North Chicago | Illinois |
United States | Research Site | North Dartmouth | Massachusetts |
United States | Research Site | North Hollywood | California |
United States | Research Site | North Richland Hills | Texas |
United States | Research Site | Northridge | California |
United States | Research Site | O'Fallon | Illinois |
United States | Research Site | Oakwood | Georgia |
United States | Research Site | Ocala | Florida |
United States | Research Site | Ocala | Florida |
United States | Research Site | Ogden | Utah |
United States | Research Site | Oklahoma City | Oklahoma |
United States | Research Site | Oklahoma City | Oklahoma |
United States | Research Site | Oklahoma City | Oklahoma |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Omaha | Nebraska |
United States | Research Site | Opelousas | Louisiana |
United States | Research Site | Orange Park | Florida |
United States | Research Site | Orangeburg | South Carolina |
United States | Research Site | Orlando | Florida |
United States | Research Site | Orlando | Florida |
United States | Research Site | Orlando | Florida |
United States | Research Site | Orlando | Florida |
United States | Research Site | Ormond Beach | Florida |
United States | Research Site | Oviedo | Florida |
United States | Research Site | Owensboro | Kentucky |
United States | Research Site | Palm Desert | California |
United States | Research Site | Palm Springs | California |
United States | Research Site | Palmetto Bay | Florida |
United States | Research Site | Panama City | Florida |
United States | Research Site | Paramount | California |
United States | Research Site | Pelzer | South Carolina |
United States | Research Site | Pembroke Pines | Florida |
United States | Research Site | Pembroke Pines | Florida |
United States | Research Site | Pensacola | Florida |
United States | Research Site | Peoria | Illinois |
United States | Research Site | Peoria | Arizona |
United States | Research Site | Philadelphia | Pennsylvania |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Phoenix | Arizona |
United States | Research Site | Pinehurst | North Carolina |
United States | Research Site | Pinellas Park | Florida |
United States | Research Site | Pismo Beach | California |
United States | Research Site | Pittsburgh | Pennsylvania |
United States | Research Site | Pittsfield | Massachusetts |
United States | Research Site | Plantation | Florida |
United States | Research Site | Port Charlotte | Florida |
United States | Research Site | Port Hueneme | California |
United States | Research Site | Port Orange | Florida |
United States | Research Site | Port Orchard | Washington |
United States | Research Site | Portland | Oregon |
United States | Research Site | Portland | Oregon |
United States | Research Site | Poway | California |
United States | Research Site | Pratt | Kansas |
United States | Research Site | Rapid City | South Dakota |
United States | Research Site | Reno | Nevada |
United States | Research Site | Rialto | California |
United States | Research Site | Richardson | Texas |
United States | Research Site | Richmond | Virginia |
United States | Research Site | Richmond | Virginia |
United States | Research Site | Richmond | Virginia |
United States | Research Site | Richmond | Virginia |
United States | Research Site | Richmond | Virginia |
United States | Research Site | Rincon | Georgia |
United States | Research Site | Riverside | California |
United States | Research Site | Riverton | Utah |
United States | Research Site | Rochester | Minnesota |
United States | Research Site | Rochester | Michigan |
United States | Research Site | Rock Hill | South Carolina |
United States | Research Site | Sacramento | California |
United States | Research Site | Sacramento | California |
United States | Research Site | Sacramento | California |
United States | Research Site | Saint Charles | Missouri |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Saint Louis | Missouri |
United States | Research Site | Saint Petersburg | Florida |
United States | Research Site | Saint Petersburg | Florida |
United States | Research Site | Saint Petersburg | Florida |
United States | Research Site | Saint Petersburg | Florida |
United States | Research Site | Salisbury | North Carolina |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Antonio | Texas |
United States | Research Site | San Diego | California |
United States | Research Site | San Diego | California |
United States | Research Site | San Francisco | California |
United States | Research Site | San Jose | California |
United States | Research Site | Santa Ana | California |
United States | Research Site | Santa Monica | California |
United States | Research Site | Santa Rosa Beach | Florida |
United States | Research Site | Sarasota | Florida |
United States | Research Site | Savannah | Georgia |
United States | Research Site | Savannah | Georgia |
United States | Research Site | Scottdale | Pennsylvania |
United States | Research Site | Sebring | Florida |
United States | Research Site | Shelby | North Carolina |
United States | Research Site | Sherman Oaks | California |
United States | Research Site | Shreveport | Louisiana |
United States | Research Site | Shreveport | Louisiana |
United States | Research Site | Slidell | Louisiana |
United States | Research Site | Smithfield | Pennsylvania |
United States | Research Site | Smyrna | Tennessee |
United States | Research Site | Snellville | Georgia |
United States | Research Site | Snellville | Georgia |
United States | Research Site | South Burlington | Vermont |
United States | Research Site | Southfield | Michigan |
United States | Research Site | Sparks | Nevada |
United States | Research Site | Spartanburg | South Carolina |
United States | Research Site | Spartanburg | South Carolina |
United States | Research Site | Spokane | Washington |
United States | Research Site | Spokane Valley | Washington |
United States | Research Site | Spring | Texas |
United States | Research Site | Spring Hill | Tennessee |
United States | Research Site | Springfield | Missouri |
United States | Research Site | Stamford | Connecticut |
United States | Research Site | Statesville | North Carolina |
United States | Research Site | Stevensville | Michigan |
United States | Research Site | Stockbridge | Georgia |
United States | Research Site | Sugar Land | Texas |
United States | Research Site | Sugar Land | Texas |
United States | Research Site | Summerville | South Carolina |
United States | Research Site | Summit | New Jersey |
United States | Research Site | Sylvania | Ohio |
United States | Research Site | Syracuse | New York |
United States | Research Site | Tabor City | North Carolina |
United States | Research Site | Tacoma | Washington |
United States | Research Site | Tamarac | Florida |
United States | Research Site | Tampa | Florida |
United States | Research Site | Toledo | Ohio |
United States | Research Site | Toledo | Ohio |
United States | Research Site | Tomball | Texas |
United States | Research Site | Toms River | New Jersey |
United States | Research Site | Topeka | Kansas |
United States | Research Site | Towson | Maryland |
United States | Research Site | Troy | Michigan |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tucson | Arizona |
United States | Research Site | Tullahoma | Tennessee |
United States | Research Site | Tulsa | Oklahoma |
United States | Research Site | Tulsa | Oklahoma |
United States | Research Site | Tuscaloosa | Alabama |
United States | Research Site | Tyler | Texas |
United States | Research Site | Union | South Carolina |
United States | Research Site | Uniontown | Pennsylvania |
United States | Research Site | Valparaiso | Indiana |
United States | Research Site | Vero Beach | Florida |
United States | Research Site | Vista | California |
United States | Research Site | Waco | Texas |
United States | Research Site | Wappingers Falls | New York |
United States | Research Site | Waterbury | Connecticut |
United States | Research Site | Webster | Texas |
United States | Research Site | Westfield | New York |
United States | Research Site | Westminster | California |
United States | Research Site | Wheat Ridge | Colorado |
United States | Research Site | Whiteville | North Carolina |
United States | Research Site | Wildomar | California |
United States | Research Site | Wilmington | Delaware |
United States | Research Site | Wilmington | North Carolina |
United States | Research Site | Winston-Salem | North Carolina |
United States | Research Site | Winston-Salem | North Carolina |
United States | Research Site | Winter Park | Florida |
United States | Research Site | Woodstock | Georgia |
United States | Research Site | Wyomissing | Pennsylvania |
United States | Research Site | Yardley | Pennsylvania |
United States | Research Site | Yukon | Oklahoma |
United States | Research Site | Zachary | Louisiana |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment | The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable. | 12 months | |
Primary | Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis | To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis). | At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU) | |
Secondary | Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis | To assess whether aclidinium bromide reduces moderate or severe COPD exacerbations. The rate of hospitalization (number of events per subject per year) due to COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline ICS use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable. | 12 months | |
Secondary | Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis | To assess the CV safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated MACE or other serious CV events of interest with treatment group, baseline CV severity, and smoking status as factors. Other serious CV events included events from Cardiac tachyarrhythmias plus preferred terms (PTs) Tachycardia, Heart rate increase, and Palpitation; Cardiac failure; Bradycardia and PTs Sinus arrest and Sinus bradycardia; Conduction defects; Conditions associated with Central nervous system haemorrhages and cerebrovascular accidents; and selected PTs included in the Other ischemic heart disease. |
At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU) |
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