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)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; COPD; Moderate to Very Severe COPD
• Intervention / Treatment: Drug: Aclidinium Bromide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 3635
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1G 3Y8
    • Research Site
  • Quebec, Canada, G3K 2P8
    • Research Site
  • Alberta
    • Edmonton, Alberta, Canada, T5A 4L8
      • Research Site
    • Edmonton, Alberta, Canada, T5J 3S9
      • Research Site
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C 5T1
      • Research Site
    • Kelowna, British Columbia, Canada, V1Y 4N7
      • Research Site
    • Langley, British Columbia, Canada, V3A 4H9
      • Research Site
    • Penticton, British Columbia, Canada, V2A 5C8
      • Research Site
    • West Vancouver, British Columbia, Canada, V7T 1E3
      • Research Site
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Research Site
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1A 3R5
      • Research Site
  • Nova Scotia
    • Bridgewater, Nova Scotia, Canada, B4V 3N2
      • Research Site
    • Halifax, Nova Scotia, Canada, B3K2M5
      • Research Site
  • Ontario
    • Ajax, Ontario, Canada, L1Z 0M1
      • Research Site
    • Burlington, Ontario, Canada, L7N 3V2
      • Research Site
    • Cornwall, Ontario, Canada, K6H 4M4
      • Research Site
    • Dorchester, Ontario, Canada, N0L 1G3
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    • Hamilton, Ontario, Canada, L8K 3P3
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    • London, Ontario, Canada, N6A 5G6
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    • London, Ontario, Canada, N5Z 1R1
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    • Newmarket, Ontario, Canada, L3Y 5G8
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    • Sudbury, Ontario, Canada, P3A 1W8
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    • Sudbury, Ontario, Canada, P3E 6C3
      • Research Site
    • Thorold, Ontario, Canada, L2V 5A7
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    • Toronto, Ontario, Canada, M5T 3A9
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    • Toronto, Ontario, Canada, M9V 4B4
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    • Toronto, Ontario, Canada, M4S 1Y2
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    • Toronto, Ontario, Canada, M3M 0B2
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    • Waterloo, Ontario, Canada, N2J 1C4
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    • Windsor, Ontario, Canada, N8X 5A6
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    • Windsor, Ontario, Canada, N8X-5A6
      • Research Site
  • Quebec
    • Longueuil, Quebec, Canada, J4N 1C2
      • Research Site
    • Montreal, Quebec, Canada, H1M 1B1
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    • St Charles Borromee, Quebec, Canada, J6E 2B4
      • Research Site
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7H 5M3
      • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
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    • Birmingham, Alabama, United States, 35294
      • Research Site
    • Birmingham, Alabama, United States, 35216
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    • Birmingham, Alabama, United States, 35211
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    • Birmingham, Alabama, United States, 35233
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    • Florence, Alabama, United States, 35630
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    • Foley, Alabama, United States, 36535
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    • Huntsville, Alabama, United States, 35801
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    • Jasper, Alabama, United States, 35501
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    • Mobile, Alabama, United States, 36604
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    • Tuscaloosa, Alabama, United States, 35404
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  • Arizona
    • Chandler, Arizona, United States, 85224
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    • Glendale, Arizona, United States, 85306
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    • Mesa, Arizona, United States, 85205
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    • Peoria, Arizona, United States, 85381
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    • Phoenix, Arizona, United States, 85018
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    • Phoenix, Arizona, United States, 85020
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    • Phoenix, Arizona, United States, 85012
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    • Phoenix, Arizona, United States, 85023
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    • Tucson, Arizona, United States, 85724
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    • Tucson, Arizona, United States, 85712
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    • Tucson, Arizona, United States, 85741
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    • Tucson, Arizona, United States, 85745
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    • Tucson, Arizona, United States, 85710
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  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
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    • Little Rock, Arkansas, United States, 72209
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    • Little Rock, Arkansas, United States, 72205
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  • California
    • Bakersfield, California, United States, 93301
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    • Encinitas, California, United States, 92024
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    • Escondido, California, United States, 92025
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    • Fresno, California, United States, 93720
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    • Gold River, California, United States, 95670
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    • Huntington Beach, California, United States, 92647
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    • La Mirada, California, United States, 90638
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    • Laguna Hills, California, United States, 92653
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    • Lincoln, California, United States, 95648
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    • Loma Linda, California, United States, 92357
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    • Los Angeles, California, United States, 90017
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    • Los Angeles, California, United States, 90048
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    • Los Angeles, California, United States, 90073
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    • North Hollywood, California, United States, 91606
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    • Northridge, California, United States, 91324
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    • Palm Desert, California, United States, 92260
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    • Palm Springs, California, United States, 92262
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    • Paramount, California, United States, 90723
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    • Pismo Beach, California, United States, 93449
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    • Port Hueneme, California, United States, 93041
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    • Poway, California, United States, 92064
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    • Rialto, California, United States, 92376
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    • Riverside, California, United States, 92262
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    • Sacramento, California, United States, 95821
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    • Sacramento, California, United States, 95817
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    • Sacramento, California, United States, 95823
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    • San Diego, California, United States, 92120
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    • San Diego, California, United States, 92117
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    • San Francisco, California, United States, 94103
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    • San Jose, California, United States, 95116
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    • Santa Ana, California, United States, 92705
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    • Santa Monica, California, United States, 90404
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    • Sherman Oaks, California, United States, 91403
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    • Vista, California, United States, 92083
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    • Westminster, California, United States, 92683
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    • Wildomar, California, United States, 92595
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  • Colorado
    • Boulder, Colorado, United States, 80304
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    • Centennial, Colorado, United States, 80112
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    • Colorado Springs, Colorado, United States, 80907
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    • Colorado Springs, Colorado, United States, 80920
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    • Golden, Colorado, United States, 80401
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    • Wheat Ridge, Colorado, United States, 80033
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  • Connecticut
    • Bristol, Connecticut, United States, 06010
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    • Stamford, Connecticut, United States, 06902
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    • Waterbury, Connecticut, United States, 06708
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  • Delaware
    • Wilmington, Delaware, United States, 19803
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  • Florida
    • Bay Pines, Florida, United States, 33744
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    • Boynton Beach, Florida, United States, 33435
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    • Brandon, Florida, United States, 33511
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    • Clearwater, Florida, United States, 33765
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    • Clearwater, Florida, United States, 33756
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    • Daytona Beach, Florida, United States, 32117
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    • DeBary, Florida, United States, 32713
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    • DeLand, Florida, United States, 32720
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    • Doral, Florida, United States, 33172
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    • Doral, Florida, United States, 33166
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    • Doral, Florida, United States, 33122
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    • Eustis, Florida, United States, 32726
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    • Gainesville, Florida, United States, 32653
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    • Hialeah, Florida, United States, 33012
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    • Hialeah, Florida, United States, 33013
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    • Hialeah, Florida, United States, 33016
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    • Hollywood, Florida, United States, 33021
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    • Hollywood, Florida, United States, 33024
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    • Homestead, Florida, United States, 33030
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    • Jacksonville, Florida, United States, 32209
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    • Jupiter, Florida, United States, 33485
      • Research Site
    • Kissimmee, Florida, United States, 34741
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    • Kissimmee, Florida, United States, 32837
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    • Leesburg, Florida, United States, 34748
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    • Loxahatchee Groves, Florida, United States, 33470
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    • Maitland, Florida, United States, 32751
      • Research Site
    • Melbourne, Florida, United States, 32901
      • Research Site
    • Miami, Florida, United States, 33126
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    • Miami, Florida, United States, 33173
      • Research Site
    • Miami, Florida, United States, 33186
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    • Miami, Florida, United States, 33165
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    • Miami, Florida, United States, 33176
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    • Miami, Florida, United States, 33134
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    • Miami, Florida, United States, 33133
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    • Miami, Florida, United States, 33144
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    • Miami, Florida, United States, 33142
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    • Miami, Florida, United States, 33135
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    • Miami, Florida, United States, 33147
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    • Miami, Florida, United States, 33183
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    • Miami Beach, Florida, United States, 33140
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    • Naples, Florida, United States, 34119
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    • New Port Richey, Florida, United States, 34653
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    • Ocala, Florida, United States, 34471
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    • Ocala, Florida, United States, 34474
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    • Orange Park, Florida, United States, 32073
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    • Orlando, Florida, United States, 32803
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    • Orlando, Florida, United States, 32825
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    • Orlando, Florida, United States, 32811
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    • Orlando, Florida, United States, 32792
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    • Ormond Beach, Florida, United States, 32174
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    • Oviedo, Florida, United States, 32765
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    • Palmetto Bay, Florida, United States, 33157
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    • Panama City, Florida, United States, 32405
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    • Pembroke Pines, Florida, United States, 33024
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    • Pembroke Pines, Florida, United States, 33029
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    • Pensacola, Florida, United States, 32503
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    • Pinellas Park, Florida, United States, 33782
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    • Plantation, Florida, United States, 33322
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    • Port Charlotte, Florida, United States, 33952
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    • Port Orange, Florida, United States, 32127
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    • Saint Petersburg, Florida, United States, 33704
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    • Saint Petersburg, Florida, United States, 33713
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    • Saint Petersburg, Florida, United States, 33708
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    • Saint Petersburg, Florida, United States, 33711
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    • Santa Rosa Beach, Florida, United States, 32459
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    • Sarasota, Florida, United States, 34239
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    • Sebring, Florida, United States, 33870
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    • Tamarac, Florida, United States, 33321
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    • Tampa, Florida, United States, 33613
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    • Vero Beach, Florida, United States, 32960
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    • Winter Park, Florida, United States, 32789
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  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Research Site
    • Atlanta, Georgia, United States, 30308
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    • Atlanta, Georgia, United States, 30310
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    • Blue Ridge, Georgia, United States, 30513
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    • Columbus, Georgia, United States, 31904
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    • Duluth, Georgia, United States, 30096
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    • Johns Creek, Georgia, United States, 30097
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    • Lawrenceville, Georgia, United States, 30046
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    • Marietta, Georgia, United States, 30066
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    • Norcross, Georgia, United States, 30092
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    • Oakwood, Georgia, United States, 30566
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    • Rincon, Georgia, United States, 31326
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    • Savannah, Georgia, United States, 31406
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    • Savannah, Georgia, United States, 31419
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    • Snellville, Georgia, United States, 30078
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    • Snellville, Georgia, United States, 30039
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    • Stockbridge, Georgia, United States, 30281
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    • Woodstock, Georgia, United States, 30189
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  • Idaho
    • Eagle, Idaho, United States, 83616
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    • Hayden Lake, Idaho, United States, 83835
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    • Idaho Falls, Idaho, United States, 83404
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    • Meridian, Idaho, United States, 83642
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    • Meridian, Idaho, United States, 83646
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  • Illinois
    • Champaign, Illinois, United States, 61820
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    • Chicago, Illinois, United States, 60611
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    • Evanston, Illinois, United States, 60201
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    • Gillespie, Illinois, United States, 62033
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    • Melrose Park, Illinois, United States, 60160
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    • Morton, Illinois, United States, 61550
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    • Normal, Illinois, United States, 61761
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    • North Chicago, Illinois, United States, 60064
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    • O'Fallon, Illinois, United States, 62269
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    • Peoria, Illinois, United States, 61602
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  • Indiana
    • Avon, Indiana, United States, 46123
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    • Elwood, Indiana, United States, 46036
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    • Evansville, Indiana, United States, 47714
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    • Evansville, Indiana, United States, 47715
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    • Michigan City, Indiana, United States, 46360
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    • Muncie, Indiana, United States, 47303
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    • Muncie, Indiana, United States, 47304
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    • Valparaiso, Indiana, United States, 46383
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  • Iowa
    • Ames, Iowa, United States, 50010-3014
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    • Council Bluffs, Iowa, United States, 51503
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    • Iowa City, Iowa, United States, 52242
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  • Kansas
    • Lenexa, Kansas, United States, 66219
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    • Pratt, Kansas, United States, 67124
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    • Topeka, Kansas, United States, 66606
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  • Kentucky
    • Bowling Green, Kentucky, United States, 42101
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    • Lexington, Kentucky, United States, 40503
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    • Louisville, Kentucky, United States, 40202
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    • Louisville, Kentucky, United States, 40218
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    • Madisonville, Kentucky, United States, 42431
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    • Owensboro, Kentucky, United States, 42303
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  • Louisiana
    • Covington, Louisiana, United States, 70433
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    • Crowley, Louisiana, United States, 70526
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    • Eunice, Louisiana, United States, 70535
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    • Lake Charles, Louisiana, United States, 70601
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    • Marshall, Louisiana, United States, 75670
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    • Metairie, Louisiana, United States, 70006
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    • New Orleans, Louisiana, United States, 70115
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    • Opelousas, Louisiana, United States, 70570
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    • Shreveport, Louisiana, United States, 71106
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    • Shreveport, Louisiana, United States, 71105
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    • Slidell, Louisiana, United States, 70458
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    • Zachary, Louisiana, United States, 70791
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  • Maine
    • Bangor, Maine, United States, 04401
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    • Biddeford, Maine, United States, 04005
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  • Maryland
    • Baltimore, Maryland, United States, 21237
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    • Baltimore, Maryland, United States, 21224
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    • Baltimore, Maryland, United States, 21236
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    • Elkridge, Maryland, United States, 21075
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    • Towson, Maryland, United States, 21204
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  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
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    • Methuen, Massachusetts, United States, 01844
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    • North Dartmouth, Massachusetts, United States, 02747
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    • Pittsfield, Massachusetts, United States, 01201
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  • Michigan
    • Bingham Farms, Michigan, United States, 48025
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    • Buckley, Michigan, United States, 49620
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    • Caro, Michigan, United States, 48723
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    • Farmington Hills, Michigan, United States, 48336
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    • Flint, Michigan, United States, 48504
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    • Rochester, Michigan, United States, 48307
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    • Southfield, Michigan, United States, 48034
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    • Stevensville, Michigan, United States, 49127
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    • Troy, Michigan, United States, 48085
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  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
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    • Rochester, Minnesota, United States, 55905
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  • Missouri
    • Bridgeton, Missouri, United States, 63044
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    • Chesterfield, Missouri, United States, 63017
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    • Saint Louis, Missouri, United States, 63128
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    • Springfield, Missouri, United States, 65807
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  • Montana
    • Missoula, Montana, United States, 59808
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  • Nebraska
    • Bellevue, Nebraska, United States, 68005
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    • Fremont, Nebraska, United States, 68025
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    • Grand Island, Nebraska, United States, 68803
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    • Lincoln, Nebraska, United States, 68516
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    • Omaha, Nebraska, United States, 68130
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    • Omaha, Nebraska, United States, 68114
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  • Nevada
    • Las Vegas, Nevada, United States, 89119
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    • Las Vegas, Nevada, United States, 89128
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    • Las Vegas, Nevada, United States, 89123
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    • Las Vegas, Nevada, United States, 89117
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    • Reno, Nevada, United States, 89502
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    • Sparks, Nevada, United States, 89434
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  • New Jersey
    • Belvidere, New Jersey, United States, 07823
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    • Bridgewater, New Jersey, United States, 08807
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    • East Brunswick, New Jersey, United States, 08816
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    • Elizabeth, New Jersey, United States, 07201
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    • Haddon Heights, New Jersey, United States, 08035
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    • Toms River, New Jersey, United States, 08755
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  • New York
    • Bronx, New York, United States, 10461
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    • Brooklyn, New York, United States, 11229
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    • Buffalo, New York, United States, 14215
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    • Hopewell Jct, New York, United States, 12533
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    • New Hyde Park, New York, United States, 11040
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    • New York, New York, United States, 10016
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    • New York, New York, United States, 10009
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    • Syracuse, New York, United States, 13210
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    • Wappingers Falls, New York, United States, 12590
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  • North Carolina
    • Asheville, North Carolina, United States, 28801
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    • Burlington, North Carolina, United States, 27215
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    • Calabash, North Carolina, United States, 28467
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    • Charlotte, North Carolina, United States, 28277
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    • Charlotte, North Carolina, United States, 28210
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    • Charlotte, North Carolina, United States, 28262
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    • Gastonia, North Carolina, United States, 28054
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    • Lenoir, North Carolina, United States, 28645
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    • Monroe, North Carolina, United States, 28112
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    • Monroe, North Carolina, United States, 28110
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    • Mooresville, North Carolina, United States, 28117
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    • New Bern, North Carolina, United States, 28562
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    • Pinehurst, North Carolina, United States, 28374
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    • Shelby, North Carolina, United States, 28150
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    • Tabor City, North Carolina, United States, 28463
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    • Winston-Salem, North Carolina, United States, 27103
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    • Winston-Salem, North Carolina, United States, 27104
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  • North Dakota
    • Fargo, North Dakota, United States, 58103
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  • Ohio
    • Akron, Ohio, United States, 44311
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    • Canton, Ohio, United States, 44718
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    • Cincinnati, Ohio, United States, 45231
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    • Columbus, Ohio, United States, 43215
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    • Columbus, Ohio, United States, 43207
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    • Dayton, Ohio, United States, 45459
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    • Dayton, Ohio, United States, 45419
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    • Dayton, Ohio, United States, 45439
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    • Delaware, Ohio, United States, 43015
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    • Dublin, Ohio, United States, 43016
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    • Kettering, Ohio, United States, 45429
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    • Maumee, Ohio, United States, 43537
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    • Sylvania, Ohio, United States, 43560
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    • Toledo, Ohio, United States, 43608
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    • Toledo, Ohio, United States, 43617
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  • Oklahoma
    • Norman, Oklahoma, United States, 73069
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    • Oklahoma City, Oklahoma, United States, 73112
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    • Oklahoma City, Oklahoma, United States, 73120
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    • Oklahoma City, Oklahoma, United States, 73103
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    • Tulsa, Oklahoma, United States, 74136
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    • Tulsa, Oklahoma, United States, 74104
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    • Yukon, Oklahoma, United States, 73099
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  • Oregon
    • Portland, Oregon, United States, 97202
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    • Portland, Oregon, United States, 97210
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  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
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    • Beaver, Pennsylvania, United States, 15009
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    • Belle Vernon, Pennsylvania, United States, 15012
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    • Bensalem, Pennsylvania, United States, 19020
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    • Carnegie, Pennsylvania, United States, 15106
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    • Clairton, Pennsylvania, United States, 15025
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    • Downingtown, Pennsylvania, United States, 19335
      • Research Site
    • Erie, Pennsylvania, United States, 16508
      • Research Site
    • Feasterville-Trevose, Pennsylvania, United States, 19053
      • Research Site
    • Jefferson Hills, Pennsylvania, United States, 15025
      • Research Site
    • Levittown, Pennsylvania, United States, 19056
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19152
      • Research Site
    • Pittsburgh, Pennsylvania, United States, 15243
      • Research Site
    • Scottdale, Pennsylvania, United States, 15683
      • Research Site
    • Smithfield, Pennsylvania, United States, 15478
      • Research Site
    • Uniontown, Pennsylvania, United States, 15401
      • Research Site
    • Wyomissing, Pennsylvania, United States, 19610
      • Research Site
    • Yardley, Pennsylvania, United States, 19067
      • Research Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site
    • Charleston, South Carolina, United States, 29406
      • Research Site
    • Charleston, South Carolina, United States, 29407
      • Research Site
    • Charleston, South Carolina, United States, 29412
      • Research Site
    • Columbia, South Carolina, United States, 29204
      • Research Site
    • Easley, South Carolina, United States, 29640
      • Research Site
    • Gaffney, South Carolina, United States, 29340
      • Research Site
    • Gaffney, South Carolina, United States, 29341
      • Research Site
    • Greenville, South Carolina, United States, 29615
      • Research Site
    • Greenville, South Carolina, United States, 29605
      • Research Site
    • Greer, South Carolina, United States, 29651
      • Research Site
    • Hodges, South Carolina, United States, 29653
      • Research Site
    • Indian Land, South Carolina, United States, 29707
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
    • Myrtle Beach, South Carolina, United States, 29588
      • Research Site
    • Orangeburg, South Carolina, United States, 29118
      • Research Site
    • Pelzer, South Carolina, United States, 29669
      • Research Site
    • Rock Hill, South Carolina, United States, 29732
      • Research Site
    • Spartanburg, South Carolina, United States, 29303
      • Research Site
    • Spartanburg, South Carolina, United States, 29302
      • Research Site
    • Summerville, South Carolina, United States, 29485
      • Research Site
    • Union, South Carolina, United States, 29379
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Research Site
  • Tennessee
    • Athens, Tennessee, United States, 37303
      • Research Site
    • Chattanooga, Tennessee, United States, 37404
      • Research Site
    • Fayetteville, Tennessee, United States, 37334
      • Research Site
    • Franklin, Tennessee, United States, 37067
      • Research Site
    • Hendersonville, Tennessee, United States, 37075
      • Research Site
    • Knoxville, Tennessee, United States, 37919
      • Research Site
    • Smyrna, Tennessee, United States, 37167
      • Research Site
    • Spring Hill, Tennessee, United States, 37174
      • Research Site
    • Tullahoma, Tennessee, United States, 37388
      • Research Site
  • Texas
    • Amarillo, Texas, United States, 79106
      • Research Site
    • Arlington, Texas, United States, 76014
      • Research Site
    • Austin, Texas, United States, 78759
      • Research Site
    • Beaumont, Texas, United States, 77702
      • Research Site
    • Boerne, Texas, United States, 78006
      • Research Site
    • Carrollton, Texas, United States, 75006
      • Research Site
    • Corsicana, Texas, United States, 75110
      • Research Site
    • Cypress, Texas, United States, 77429
      • Research Site
    • Dallas, Texas, United States, 75225
      • Research Site
    • Dallas, Texas, United States, 75246
      • Research Site
    • Dallas, Texas, United States, 75235
      • Research Site
    • Dallas, Texas, United States, 75220
      • Research Site
    • Dickinson, Texas, United States, 77539
      • Research Site
    • Duncanville, Texas, United States, 75116
      • Research Site
    • Fort Worth, Texas, United States, 76104
      • Research Site
    • Fort Worth, Texas, United States, 76107
      • Research Site
    • Georgetown, Texas, United States, 78626
      • Research Site
    • Houston, Texas, United States, 77058
      • Research Site
    • Houston, Texas, United States, 77043
      • Research Site
    • Houston, Texas, United States, 77011
      • Research Site
    • Irving, Texas, United States, 75039
      • Research Site
    • North Richland Hills, Texas, United States, 76180
      • Research Site
    • Richardson, Texas, United States, 75080
      • Research Site
    • San Antonio, Texas, United States, 78258
      • Research Site
    • San Antonio, Texas, United States, 78218
      • Research Site
    • Spring, Texas, United States, 77379
      • Research Site
    • Sugar Land, Texas, United States, 77478
      • Research Site
    • Sugar Land, Texas, United States, 77479
      • Research Site
    • Tomball, Texas, United States, 77375
      • Research Site
    • Tyler, Texas, United States, 75708
      • Research Site
    • Waco, Texas, United States, 76710
      • Research Site
    • Webster, Texas, United States, 77598
      • Research Site
  • Utah
    • Midvale, Utah, United States, 84047
      • Research Site
    • Murray, Utah, United States, 84107
      • Research Site
    • Ogden, Utah, United States, 84405
      • Research Site
    • Riverton, Utah, United States, 84065
      • Research Site
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • Research Site
  • Virginia
    • Abingdon, Virginia, United States, 24210
      • Research Site
    • Manassas, Virginia, United States, 20110
      • Research Site
    • Richmond, Virginia, United States, 23225
      • Research Site
    • Richmond, Virginia, United States, 23220
      • Research Site
    • Richmond, Virginia, United States, 23219
      • Research Site
    • Richmond, Virginia, United States, 23229
      • Research Site
    • Richmond, Virginia, United States, 23114
      • Research Site
  • Washington
    • Bellevue, Washington, United States, 98007
      • Research Site
    • Bellingham, Washington, United States, 98225
      • Research Site
    • Everett, Washington, United States, 98208
      • Research Site
    • Port Orchard, Washington, United States, 98366
      • Research Site
    • Spokane, Washington, United States, 99204
      • Research Site
    • Spokane Valley, Washington, United States, 99216
      • Research Site
    • Tacoma, Washington, United States, 98405
      • Research Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • Research Site
    • Lewisburg, West Virginia, United States, 24901
      • Research Site
    • Morgantown, West Virginia, United States, 26505
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 β-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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aclidinium Bromide; Two-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.	Drug: Aclidinium Bromide; 400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Placebo Comparator: Placebo; Two-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.	Drug: Placebo; Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• Wise 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.
• Wise 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.
• Wise 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.

Helpful Links

• Protocol
• Statistical Analysis Plan (SAP)

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2013
• Primary Completion (Actual): September 21, 2017
• Study Completion (Actual): September 21, 2017

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Actual): December 6, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anticonvulsants; Bromides
• Other Study ID Numbers: D6560C00002; LAS-MD-45 (Other Identifier: Forest Research)