Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
ASCENT COPD
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)
2 other identifiers
interventional
3,635
2 countries
468
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2013
Longer than P75 for phase_4
468 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2013
CompletedStudy Start
First participant enrolled
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 21, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2017
CompletedResults Posted
Study results publicly available
December 6, 2018
CompletedDecember 6, 2018
November 1, 2018
3.9 years
October 16, 2013
September 19, 2018
November 8, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis
12 months
Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis
At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
Study Arms (2)
Aclidinium Bromide
EXPERIMENTALTwo-week washout/run-in period \[for patients on a long-acting muscarinic antagonist (LAMA)\] followed by a maximum of 36-month double-blind treatment period.
Placebo
PLACEBO COMPARATORTwo-week washout/run-in period \[for patients on a long-acting muscarinic antagonist (LAMA)\] followed by a maximum of 36-month double-blind treatment period.
Interventions
400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Eligibility Criteria
You may qualify if:
- \. Male or female outpatients ≥ 40 years of age
- \. Current or former cigarette smokers with a smoking history of at least 10 pack-years
- \. A diagnosis of stable, moderate to very severe COPD (GOLD, 2015) with a post-bronchodilator FEV \< 80% FEV1/forced vital capacity (FVC) ratio \< 70%
- \. Must have at least one of the following 4 criteria:
- Documented cerebrovascular disease (stroke or transient ischemic attack, carotid stenosis)
- Documented coronary artery disease (angina, MI, angioplasty/stent/bypass)
- Documented peripheral vascular disease or history of claudication
- At least 2 of the following atherothrombotic risk factors as determined by the PI:
- Male ≥ 65 years or female ≥ 70 years
- Diabetes
- Dyslipidemia
- Hypertension
- Waist circumference inches males ≥ 40 in or in females ≥ 38 inches
- 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)
- \. Maintained stable respiratory medications for 2 weeks prior to randomization (Appendix II)
- +3 more criteria
You may not qualify if:
- \. 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
- \. Unstable or life threatening cardiovascular disease or COPD as determined by the PI
- \. Patients with comorbid lung disease such as asthma, cystic fibrosis, bronchiectasis, interstitial lung disease, or pulmonary thromboembolic disease
- \. Planned lung transplant or lung volume reduction surgery
- \. Currently treated with a combination of LAMA and LABA/ICS therapy.
- \. 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
- \. Respiratory infection or COPD exacerbation at Screening and/or within 4 weeks prior to screening
- \. Uncontrolled infection resulting from human immunodeficiency virus (HIV) and/or active hepatitis
- \. Reported history of drug or alcohol abuse within the past 12 months
- \. History of hypersensitivity reaction to inhaled anticholinergics, sympathomimetic amines, or inhaled medication or any component thereof (including report of paradoxical bronchospasm)
- \. 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)
- \. Patients unable to use a multidose DPI or a pressurized metered-dose inhaler
- \. Treatment with any other investigational drug within 30 days (or 6 half-lives, whichever is longer) before Visit 1A
- \. Women who are pregnant or breastfeeding
- \. Use of any prohibited medication listed in Appendix II
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (468)
Research Site
Birmingham, Alabama, 35209, United States
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Birmingham, Alabama, 35211, United States
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Birmingham, Alabama, 35216, United States
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Birmingham, Alabama, 35233, United States
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Birmingham, Alabama, 35294, United States
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Florence, Alabama, 35630, United States
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Foley, Alabama, 36535, United States
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Huntsville, Alabama, 35801, United States
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Jasper, Alabama, 35501, United States
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Mobile, Alabama, 36604, United States
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Tuscaloosa, Alabama, 35404, United States
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Chandler, Arizona, 85224, United States
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Glendale, Arizona, 85306, United States
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Mesa, Arizona, 85205, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85012, United States
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Phoenix, Arizona, 85018, United States
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Phoenix, Arizona, 85020, United States
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Phoenix, Arizona, 85023, United States
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Tucson, Arizona, 85710, United States
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Tucson, Arizona, 85712, United States
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Tucson, Arizona, 85724, United States
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Tucson, Arizona, 85741, United States
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Tucson, Arizona, 85745, United States
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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72209, United States
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Bakersfield, California, 93301, United States
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Encinitas, California, 92024, United States
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Escondido, California, 92025, United States
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Fresno, California, 93720, United States
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Gold River, California, 95670, United States
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Huntington Beach, California, 92647, United States
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La Mirada, California, 90638, United States
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Laguna Hills, California, 92653, United States
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Lincoln, California, 95648, United States
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Loma Linda, California, 92357, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90048, United States
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Los Angeles, California, 90073, United States
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North Hollywood, California, 91606, United States
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Northridge, California, 91324, United States
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Palm Desert, California, 92260, United States
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Palm Springs, California, 92262, United States
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Paramount, California, 90723, United States
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Pismo Beach, California, 93449, United States
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Port Hueneme, California, 93041, United States
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Poway, California, 92064, United States
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Rialto, California, 92376, United States
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Riverside, California, 92262, United States
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Sacramento, California, 95817, United States
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Sacramento, California, 95821, United States
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Sacramento, California, 95823, United States
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San Diego, California, 92117, United States
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San Diego, California, 92120, United States
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San Francisco, California, 94103, United States
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San Jose, California, 95116, United States
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Santa Ana, California, 92705, United States
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Santa Monica, California, 90404, United States
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Sherman Oaks, California, 91403, United States
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Vista, California, 92083, United States
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Westminster, California, 92683, United States
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Wildomar, California, 92595, United States
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Boulder, Colorado, 80304, United States
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Centennial, Colorado, 80112, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80920, United States
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Golden, Colorado, 80401, United States
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Wheat Ridge, Colorado, 80033, United States
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Bristol, Connecticut, 06010, United States
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Stamford, Connecticut, 06902, United States
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Waterbury, Connecticut, 06708, United States
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Wilmington, Delaware, 19803, United States
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Bay Pines, Florida, 33744, United States
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Boynton Beach, Florida, 33435, United States
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Brandon, Florida, 33511, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Daytona Beach, Florida, 32117, United States
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DeBary, Florida, 32713, United States
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DeLand, Florida, 32720, United States
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Doral, Florida, 33122, United States
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Doral, Florida, 33166, United States
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Doral, Florida, 33172, United States
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Eustis, Florida, 32726, United States
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Gainesville, Florida, 32653, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33013, United States
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Hialeah, Florida, 33016, United States
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Hollywood, Florida, 33021, United States
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Hollywood, Florida, 33024, United States
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Homestead, Florida, 33030, United States
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Jacksonville, Florida, 32209, United States
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Jupiter, Florida, 33485, United States
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Kissimmee, Florida, 32837, United States
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Kissimmee, Florida, 34741, United States
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Leesburg, Florida, 34748, United States
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Loxahatchee Groves, Florida, 33470, United States
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Maitland, Florida, 32751, United States
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Melbourne, Florida, 32901, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33133, United States
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Miami, Florida, 33134, United States
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Miami, Florida, 33135, United States
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Miami, Florida, 33142, United States
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Miami, Florida, 33144, United States
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Miami, Florida, 33147, United States
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Miami, Florida, 33165, United States
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Miami, Florida, 33173, United States
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Miami, Florida, 33176, United States
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Miami, Florida, 33183, United States
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Miami, Florida, 33186, United States
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Miami Beach, Florida, 33140, United States
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Naples, Florida, 34119, United States
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New Port Richey, Florida, 34653, United States
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Ocala, Florida, 34471, United States
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Ocala, Florida, 34474, United States
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Orange Park, Florida, 32073, United States
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Orlando, Florida, 32792, United States
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Orlando, Florida, 32803, United States
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Orlando, Florida, 32811, United States
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Orlando, Florida, 32825, United States
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Ormond Beach, Florida, 32174, United States
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Oviedo, Florida, 32765, United States
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Palmetto Bay, Florida, 33157, United States
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Panama City, Florida, 32405, United States
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Pembroke Pines, Florida, 33024, United States
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Pembroke Pines, Florida, 33029, United States
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Pensacola, Florida, 32503, United States
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Pinellas Park, Florida, 33782, United States
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Plantation, Florida, 33322, United States
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Port Charlotte, Florida, 33952, United States
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Port Orange, Florida, 32127, United States
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Santa Rosa Beach, Florida, 32459, United States
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Sarasota, Florida, 34239, United States
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Sebring, Florida, 33870, United States
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St. Petersburg, Florida, 33704, United States
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St. Petersburg, Florida, 33708, United States
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St. Petersburg, Florida, 33711, United States
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St. Petersburg, Florida, 33713, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33613, United States
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Vero Beach, Florida, 32960, United States
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Winter Park, Florida, 32789, United States
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Atlanta, Georgia, 30308, United States
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Atlanta, Georgia, 30310, United States
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Atlanta, Georgia, 30342, United States
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Blue Ridge, Georgia, 30513, United States
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Columbus, Georgia, 31904, United States
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Duluth, Georgia, 30096, United States
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Johns Creek, Georgia, 30097, United States
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Lawrenceville, Georgia, 30046, United States
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Marietta, Georgia, 30066, United States
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Norcross, Georgia, 30092, United States
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Oakwood, Georgia, 30566, United States
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Rincon, Georgia, 31326, United States
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Savannah, Georgia, 31406, United States
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Savannah, Georgia, 31419, United States
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Snellville, Georgia, 30039, United States
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Snellville, Georgia, 30078, United States
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Stockbridge, Georgia, 30281, United States
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Woodstock, Georgia, 30189, United States
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Eagle, Idaho, 83616, United States
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Hayden Lake, Idaho, 83835, United States
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Idaho Falls, Idaho, 83404, United States
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Meridian, Idaho, 83642, United States
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Meridian, Idaho, 83646, United States
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Champaign, Illinois, 61820, United States
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Chicago, Illinois, 60611, United States
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Evanston, Illinois, 60201, United States
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Gillespie, Illinois, 62033, United States
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Melrose Park, Illinois, 60160, United States
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Morton, Illinois, 61550, United States
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Normal, Illinois, 61761, United States
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North Chicago, Illinois, 60064, United States
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O'Fallon, Illinois, 62269, United States
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Peoria, Illinois, 61602, United States
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Avon, Indiana, 46123, United States
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Elwood, Indiana, 46036, United States
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Evansville, Indiana, 47714, United States
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Evansville, Indiana, 47715, United States
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Michigan City, Indiana, 46360, United States
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Muncie, Indiana, 47303, United States
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Muncie, Indiana, 47304, United States
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Valparaiso, Indiana, 46383, United States
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Ames, Iowa, 50010-3014, United States
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Council Bluffs, Iowa, 51503, United States
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Iowa City, Iowa, 52242, United States
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Lenexa, Kansas, 66219, United States
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Pratt, Kansas, 67124, United States
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Topeka, Kansas, 66606, United States
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Bowling Green, Kentucky, 42101, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40218, United States
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Madisonville, Kentucky, 42431, United States
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Owensboro, Kentucky, 42303, United States
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Covington, Louisiana, 70433, United States
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Crowley, Louisiana, 70526, United States
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Eunice, Louisiana, 70535, United States
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Lake Charles, Louisiana, 70601, United States
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Marshall, Louisiana, 75670, United States
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Metairie, Louisiana, 70006, United States
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New Orleans, Louisiana, 70115, United States
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Opelousas, Louisiana, 70570, United States
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Shreveport, Louisiana, 71105, United States
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Shreveport, Louisiana, 71106, United States
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Slidell, Louisiana, 70458, United States
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Zachary, Louisiana, 70791, United States
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Bangor, Maine, 04401, United States
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Biddeford, Maine, 04005, United States
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Baltimore, Maryland, 21224, United States
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Baltimore, Maryland, 21236, United States
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Baltimore, Maryland, 21237, United States
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Elkridge, Maryland, 21075, United States
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Towson, Maryland, 21204, United States
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Fall River, Massachusetts, 02720, United States
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Methuen, Massachusetts, 01844, United States
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North Dartmouth, Massachusetts, 02747, United States
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Pittsfield, Massachusetts, 01201, United States
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Bingham Farms, Michigan, 48025, United States
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Buckley, Michigan, 49620, United States
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Caro, Michigan, 48723, United States
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Chesterfield, Michigan, 48047, United States
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Farmington Hills, Michigan, 48336, United States
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Flint, Michigan, 48504, United States
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Rochester, Michigan, 48307, United States
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Southfield, Michigan, 48034, United States
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Stevensville, Michigan, 49127, United States
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Troy, Michigan, 48085, United States
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Minneapolis, Minnesota, 55402, United States
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Rochester, Minnesota, 55905, United States
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Bridgeton, Missouri, 63044, United States
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Chesterfield, Missouri, 63017, United States
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Columbia, Missouri, 65212, United States
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Kansas City, Missouri, 64128, United States
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Kansas City, Missouri, 64133, United States
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Saint Charles, Missouri, 63301, United States
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Springfield, Missouri, 65807, United States
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St Louis, Missouri, 63128, United States
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St Louis, Missouri, 63141, United States
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St Louis, Missouri, 63143, United States
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Missoula, Montana, 59808, United States
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Bellevue, Nebraska, 68005, United States
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Fremont, Nebraska, 68025, United States
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Grand Island, Nebraska, 68803, United States
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Lincoln, Nebraska, 68510, United States
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Lincoln, Nebraska, 68516, United States
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Omaha, Nebraska, 68114, United States
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Omaha, Nebraska, 68124, United States
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Omaha, Nebraska, 68130, United States
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Omaha, Nebraska, 68134, United States
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Omaha, Nebraska, 68144, United States
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Las Vegas, Nevada, 89117, United States
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Las Vegas, Nevada, 89119, United States
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Las Vegas, Nevada, 89123, United States
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Las Vegas, Nevada, 89128, United States
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Reno, Nevada, 89502, United States
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Sparks, Nevada, 89434, United States
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Belvidere, New Jersey, 07823, United States
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Bridgewater, New Jersey, 08807, United States
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East Brunswick, New Jersey, 08816, United States
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Elizabeth, New Jersey, 07201, United States
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Haddon Heights, New Jersey, 08035, United States
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Summit, New Jersey, 07901, United States
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Toms River, New Jersey, 08755, United States
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Brooklyn, New York, 11229, United States
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Buffalo, New York, 14215, United States
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Hopewell Jct, New York, 12533, United States
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Jamaica, New York, 11435, United States
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New Hyde Park, New York, 11040, United States
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New York, New York, 10009, United States
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New York, New York, 10016, United States
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Syracuse, New York, 13210, United States
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The Bronx, New York, 10461, United States
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Wappingers Falls, New York, 12590, United States
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Westfield, New York, 14787, United States
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Asheville, North Carolina, 28801, United States
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Burlington, North Carolina, 27215, United States
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Calabash, North Carolina, 28467, United States
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Charlotte, North Carolina, 28210, United States
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Charlotte, North Carolina, 28262, United States
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Charlotte, North Carolina, 28277, United States
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Gastonia, North Carolina, 28054, United States
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Greensboro, North Carolina, 27405, United States
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Greenville, North Carolina, 27834, United States
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Hendersonville, North Carolina, 28739, United States
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High Point, North Carolina, 27262, United States
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Huntersville, North Carolina, 28078, United States
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Lenoir, North Carolina, 28645, United States
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Monroe, North Carolina, 28110, United States
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Monroe, North Carolina, 28112, United States
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Mooresville, North Carolina, 28117, United States
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New Bern, North Carolina, 28562, United States
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Pinehurst, North Carolina, 28374, United States
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Salisbury, North Carolina, 28144, United States
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Shelby, North Carolina, 28150, United States
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Statesville, North Carolina, 28625, United States
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Tabor City, North Carolina, 28463, United States
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Whiteville, North Carolina, 28472, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Winston-Salem, North Carolina, 27104, United States
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Fargo, North Dakota, 58103, United States
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Akron, Ohio, 44311, United States
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Canton, Ohio, 44718, United States
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Cincinnati, Ohio, 45231, United States
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Columbus, Ohio, 43207, United States
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Columbus, Ohio, 43215, United States
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Dayton, Ohio, 45419, United States
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Dayton, Ohio, 45439, United States
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Dayton, Ohio, 45459, United States
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Delaware, Ohio, 43015, United States
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Dublin, Ohio, 43016, United States
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Kettering, Ohio, 45429, United States
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Maumee, Ohio, 43537, United States
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Sylvania, Ohio, 43560, United States
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Toledo, Ohio, 43608, United States
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Toledo, Ohio, 43617, United States
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Norman, Oklahoma, 73069, United States
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Oklahoma City, Oklahoma, 73103, United States
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Oklahoma City, Oklahoma, 73112, United States
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Oklahoma City, Oklahoma, 73120, United States
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Tulsa, Oklahoma, 74104, United States
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Tulsa, Oklahoma, 74136, United States
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Yukon, Oklahoma, 73099, United States
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Portland, Oregon, 97202, United States
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Portland, Oregon, 97210, United States
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Altoona, Pennsylvania, 16602, United States
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Beaver, Pennsylvania, 15009, United States
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Belle Vernon, Pennsylvania, 15012, United States
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Bensalem, Pennsylvania, 19020, United States
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Carnegie, Pennsylvania, 15106, United States
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Clairton, Pennsylvania, 15025, United States
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Downingtown, Pennsylvania, 19335, United States
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Erie, Pennsylvania, 16508, United States
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Feasterville-Trevose, Pennsylvania, 19053, United States
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Jefferson Hills, Pennsylvania, 15025, United States
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Levittown, Pennsylvania, 19056, United States
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Philadelphia, Pennsylvania, 19152, United States
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Pittsburgh, Pennsylvania, 15243, United States
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Scottdale, Pennsylvania, 15683, United States
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Smithfield, Pennsylvania, 15478, United States
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Uniontown, Pennsylvania, 15401, United States
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Wyomissing, Pennsylvania, 19610, United States
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Yardley, Pennsylvania, 19067, United States
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East Providence, Rhode Island, 02914, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29406, United States
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Charleston, South Carolina, 29407, United States
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Charleston, South Carolina, 29412, United States
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Columbia, South Carolina, 29204, United States
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Easley, South Carolina, 29640, United States
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Gaffney, South Carolina, 29340, United States
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Gaffney, South Carolina, 29341, United States
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Greenville, South Carolina, 29605, United States
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Greenville, South Carolina, 29615, United States
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Greer, South Carolina, 29651, United States
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Hodges, South Carolina, 29653, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Myrtle Beach, South Carolina, 29588, United States
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Old Point Station, South Carolina, 29707, United States
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Orangeburg, South Carolina, 29118, United States
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Pelzer, South Carolina, 29669, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29302, United States
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Spartanburg, South Carolina, 29303, United States
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Summerville, South Carolina, 29485, United States
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Union, South Carolina, 29379, United States
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Rapid City, South Dakota, 57702, United States
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Athens, Tennessee, 37303, United States
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Chattanooga, Tennessee, 37404, United States
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Fayetteville, Tennessee, 37334, United States
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South Burlington, Vermont, 05403, United States
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Abingdon, Virginia, 24210, United States
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Bellevue, Washington, 98007, United States
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Edmonton, Alberta, T5A 4L8, Canada
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Related Publications (4)
Chapman KR, Wise RA, Scirica BM, Bhatt DL, Daoud SZ, Lythgoe D, Gil EG. Long-acting antimuscarinic therapy in patients with chronic obstructive pulmonary disease receiving beta-blockers. Respir Res. 2021 Oct 22;22(1):272. doi: 10.1186/s12931-021-01861-2.
PMID: 34686204DERIVEDWise RA, Scirica BM, Bhatt DL, Daoud SZ, Chuecos F, Garcia Gil E, Chapman KR. Efficacy of Aclidinium Bromide According to Baseline Therapy: Post-Hoc Analysis of ASCENT-COPD Randomized Trial. Adv Ther. 2021 Oct;38(10):5381-5397. doi: 10.1007/s12325-021-01878-5. Epub 2021 Sep 15.
PMID: 34528220DERIVEDWise RA, Chapman KR, Scirica BM, Daoud SZ, Lythgoe D, Garcia-Gil E. The Impact of Exacerbation History on the Safety and Efficacy of Aclidinium in Patients with Chronic Obstructive Pulmonary Disease and Increased Cardiovascular Risk: ASCENT-COPD Trial. Int J Chron Obstruct Pulmon Dis. 2021 Mar 18;16:689-699. doi: 10.2147/COPD.S285068. eCollection 2021.
PMID: 33776428DERIVEDWise RA, Chapman KR, Scirica BM, Bhatt DL, Daoud SZ, Zetterstrand S, Reisner C, Gil EG. Effect of Aclidinium Bromide on Major Cardiovascular Events and Exacerbations in High-Risk Patients With Chronic Obstructive Pulmonary Disease: The ASCENT-COPD Randomized Clinical Trial. JAMA. 2019 May 7;321(17):1693-1701. doi: 10.1001/jama.2019.4973.
PMID: 31063575DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- AstraZeneca Clinical
- Organization
- Study Information Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth R. Chapman, MD MSc FRCPC FACP FCCP
GSK-CIHR Research Chair in Respiratory Health Care Delivery,
- PRINCIPAL INVESTIGATOR
Robert Wise, MD
Johns Hopkins Bayview Medical Center, Asthma and Allergy Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 21, 2013
Study Start
October 16, 2013
Primary Completion
September 21, 2017
Study Completion
September 21, 2017
Last Updated
December 6, 2018
Results First Posted
December 6, 2018
Record last verified: 2018-11