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Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Aclidinium bromide
Aclidinium bromide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
  • Current or former cigarette smokers

Exclusion Criteria:

  • Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
  • Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
  • Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
  • History or presence of asthma verified from medical records
  • Chronic use of oxygen therapy greater than or equal to 15 hours per day
  • Patient with uncontrolled infection due to HIV and/or active hepatitis
  • Patients with a history of hypersensitivity reaction to inhaled anticholinergics
  • Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Aclidinium bromide dose, inhaled, for 12 weeks of treatment

Inhaled placebo for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

Secondary Outcome Measures

Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)

Full Information

First Posted
April 30, 2009
Last Updated
November 16, 2016
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00891462
Brief Title
Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)
Official Title
Efficacy and Safety of Aclidinium Bromide at Two Dose Levels (200 μg Twice Daily, 400 μg Twice Daily) vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Chronic Obstructive Pulmonary Disease, Chronic Bronchitis, Emphysema, Airflow Obstruction, Chronic, Chronic Airflow Obstruction, Chronic Obstructive Airway Disease, Chronic Obstructive Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
561 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
Arm Title
2
Arm Type
Experimental
Arm Description
Aclidinium bromide dose, inhaled, for 12 weeks of treatment
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Inhaled placebo for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Aclidinium bromide
Intervention Description
Aclidinium bromide 400 μg, oral inhalation twice per day for 12 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1)
Description
Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)
Time Frame
Change from Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1)
Description
Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF)
Time Frame
Change from Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2009; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted Current or former cigarette smokers Exclusion Criteria: Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1 Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness History or presence of asthma verified from medical records Chronic use of oxygen therapy greater than or equal to 15 hours per day Patient with uncontrolled infection due to HIV and/or active hepatitis Patients with a history of hypersensitivity reaction to inhaled anticholinergics Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Garcia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
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United States
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Forest Investigative Site
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Forest Investigative Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
18020
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United States
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Forest Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
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United States
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Forest Investigative Site
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Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
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United States
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Forest Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
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United States
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Forest Investigative Site
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Anaheim
State/Province
California
ZIP/Postal Code
92801
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United States
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Forest Investigative Site
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Encinitas
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California
ZIP/Postal Code
92024
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United States
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Forest Investigative Site
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Fresno
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California
ZIP/Postal Code
93726
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United States
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Forest Investigative Site
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Fullerton
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California
ZIP/Postal Code
92835
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United States
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Forest Investigative Site
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Lakewood
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California
ZIP/Postal Code
90712
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United States
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Forest Investigative Site
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Orange
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California
ZIP/Postal Code
92868
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United States
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Forest Investigative Site
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Palo Alto
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California
ZIP/Postal Code
94304
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United States
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Forest Investigative Site
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Rancho Mirage
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California
ZIP/Postal Code
92270
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United States
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Forest Investigative Site
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Sacramento
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California
ZIP/Postal Code
95831
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United States
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Forest Investigative Site
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San Diego
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California
ZIP/Postal Code
92103-8415
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United States
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Forest Investigative Site
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San Diego
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California
ZIP/Postal Code
92120
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United States
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Forest Investigative Site
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Colorado Springs
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Colorado
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80907
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United States
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Denver
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Colorado
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80206
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United States
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Wheat Ridge
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Colorado
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80033
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United States
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Waterbury
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Connecticut
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06708
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United States
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Brandon
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Florida
ZIP/Postal Code
33511
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United States
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Clearwater
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Florida
ZIP/Postal Code
33765
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United States
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DeLand
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Florida
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32720
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United States
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Forest Investigative Site
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Fort Lauderdale
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Florida
ZIP/Postal Code
33316
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United States
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Melbourne
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Florida
ZIP/Postal Code
32901
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United States
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Melbourne
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Florida
ZIP/Postal Code
32935
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United States
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Forest Investigative Site
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Ormond Beach
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Florida
ZIP/Postal Code
32174
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United States
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Panama City
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Florida
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32405
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United States
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Pensacola
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Florida
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32504
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United States
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Tamarac
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Florida
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33321
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United States
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Tampa
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Florida
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33603
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United States
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Tampa
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Florida
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33613
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Austell
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Georgia
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30106
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United States
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Blue Ridge
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Georgia
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30513
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United States
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Duluth
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Georgia
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30096
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United States
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Marietta
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Georgia
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30060
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United States
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River Forest
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Illinois
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60305
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United States
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Skokie
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Illinois
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60076
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United States
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South Bend
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Indiana
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46617
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United States
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Crescent Springs
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Kentucky
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41017
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United States
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Lexington
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Kentucky
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40504
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United States
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Lafayette
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Louisiana
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70503
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United States
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Bangor
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Maine
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04401
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United States
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Baltimore
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Maryland
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21201
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United States
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Baltimore
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Maryland
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21224
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United States
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Hagerstown
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Maryland
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21740
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North Dartmouth
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Massachusetts
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02747
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Livonia
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48152
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Edina
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55435
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United States
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Minneapolis
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Minnesota
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55402
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Minneapolis
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55407
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Florissant
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63033
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United States
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Saint Charles
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Missouri
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63301
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United States
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Billings
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Montana
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59102
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United States
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Butte
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Montana
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59701
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United States
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Papillion
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Nebraska
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68046
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United States
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Berlin
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New Jersey
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08009
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United States
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Summit
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New Jersey
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07901
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United States
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Forest Investigative Site
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Brooklyn
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New York
ZIP/Postal Code
11234
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United States
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Buffalo
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New York
ZIP/Postal Code
14215
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United States
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Forest Investigative Site
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Great Neck
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New York
ZIP/Postal Code
11023
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United States
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Forest Investigative Site
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Ithaca
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New York
ZIP/Postal Code
14580
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United States
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Forest Investigative Site
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New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
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United States
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Forest Investigative Site
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New York
State/Province
New York
ZIP/Postal Code
10004
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United States
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Forest Investigative Site
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New York
State/Province
New York
ZIP/Postal Code
10016
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United States
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Forest Investigative Site
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Asheville
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North Carolina
ZIP/Postal Code
28801
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United States
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Charlotte
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North Carolina
ZIP/Postal Code
28207
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United States
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Forest Investigative Site
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Raleigh
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North Carolina
ZIP/Postal Code
27607
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United States
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Forest Investigative Site
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Canton
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Ohio
ZIP/Postal Code
44718
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United States
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Forest Investigative Site
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
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United States
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Forest Investigative Site
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
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United States
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Forest Investigative Site
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
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United States
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Forest Investigative Site
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Columbus
State/Province
Ohio
ZIP/Postal Code
43215
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United States
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Forest Investigative Site
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Toledo
State/Province
Ohio
ZIP/Postal Code
43606
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United States
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Forest Investigative Site
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Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
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United States
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Forest Investigative Site
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Medford
State/Province
Oregon
ZIP/Postal Code
97504
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United States
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Forest Investigative Site
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Portland
State/Province
Oregon
ZIP/Postal Code
97213
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United States
Facility Name
Forest Investigative Site
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Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18020
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United States
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Forest Investigative Site
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Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
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United States
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Forest Investigative Site
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Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
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United States
Facility Name
Forest Investigative Site
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Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
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United States
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Forest Investigative Site
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Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
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United States
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Forest Investigative Site
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East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
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United States
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Forest Investigative Site
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
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United States
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Forest Investigative Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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United States
Facility Name
Forest Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
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United States
Facility Name
Forest Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
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United States
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Forest Investigative Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
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United States
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Forest Investigative Site
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Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2650
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United States
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Forest Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
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Forest Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
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United States
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Forest Investigative Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
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United States
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Forest Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
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United States
Facility Name
Forest Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
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United States
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Forest Investigative Site
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Tyler
State/Province
Texas
ZIP/Postal Code
75708
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United States
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Forest Investigative Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
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United States
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Forest Investigative Site
City
Midvale
State/Province
Utah
ZIP/Postal Code
84047
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United States
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Forest Investigative Site
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Richmond
State/Province
Virginia
ZIP/Postal Code
23225
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United States
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Forest Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
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United States
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Forest Investigative Site
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Bellingham
State/Province
Washington
ZIP/Postal Code
98225
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United States
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Forest Investigative Site
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Spokane
State/Province
Washington
ZIP/Postal Code
99204
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United States
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Forest Investigative Site
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Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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United States
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Forest Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
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United States
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Forest Investigative Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Forest Investigative Site
City
Edmonton
ZIP/Postal Code
T5J 3S9
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Canada
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Forest Investigative Site
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Hamilton
ZIP/Postal Code
L8N 4A6
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Canada
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Forest Investigative Site
City
Kelowna
ZIP/Postal Code
V1Y 8E7
Country
Canada
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Forest Investigative Site
City
Niagara Falls
ZIP/Postal Code
L2G 1J4
Country
Canada
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Forest Investigative Site
City
Sainte-Foy
ZIP/Postal Code
G1V 4G5
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Canada
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Forest Investigative Site
City
Toronto
ZIP/Postal Code
M5g 1N8
Country
Canada
Facility Name
Forest Investigative Site
City
Toronto
ZIP/Postal Code
M6H 3M2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28074135
Citation
McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016.
Results Reference
derived
PubMed Identifier
22320148
Citation
Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Aclidinium Bromide for Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-33)

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