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Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients. (ASCENT COPD)

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Aclidinium Bromide

Placebo

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aclidinium Bromide

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

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).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01966107

First Posted

October 16, 2013

Last Updated

November 8, 2018

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01966107

Brief Title

Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.

Acronym

ASCENT COPD

Official Title

Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase IV Study to Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and COPD Exacerbations in Patients With Moderate to Very Severe COPD (ASCENT COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

October 16, 2013 (Actual)

Primary Completion Date

September 21, 2017 (Actual)

Study Completion Date

September 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

3635 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aclidinium Bromide

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Aclidinium Bromide

Intervention Description

400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)

Primary Outcome Measure Information:

Title

Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment

Description

Time Frame

12 months

Title

Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis

Description

Time Frame

At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)

Secondary Outcome Measure Information:

Title

Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis

Description

Time Frame

12 months

Title

Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis

Description

Time Frame

At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth R. Chapman, MD MSc FRCPC FACP FCCP

Organizational Affiliation

GSK-CIHR Research Chair in Respiratory Health Care Delivery,

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert Wise, MD

Organizational Affiliation

Johns Hopkins Bayview Medical Center, Asthma and Allergy Center

Official's Role

Principal Investigator

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Birmingham

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Alabama

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Birmingham

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Birmingham

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Doral

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Doral

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Gainesville

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33012

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Hialeah

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Hialeah

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Hollywood

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Hollywood

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Kissimmee

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State/Province

Florida

ZIP/Postal Code

33140

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33142

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33147

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33183

Country

United States

Facility Name

Research Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Research Site

City

Naples

State/Province

Florida

ZIP/Postal Code

34119

Country

United States

Facility Name

Research Site

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34653

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34471

Country

United States

Facility Name

Research Site

City

Ocala

State/Province

Florida

ZIP/Postal Code

34474

Country

United States

Facility Name

Research Site

City

Orange Park

State/Province

Florida

ZIP/Postal Code

32073

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32792

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32811

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Research Site

City

Ormond Beach

State/Province

Florida

ZIP/Postal Code

32174

Country

United States

Facility Name

Research Site

City

Oviedo

State/Province

Florida

ZIP/Postal Code

32765

Country

United States

Facility Name

Research Site

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Facility Name

Research Site

City

Panama City

State/Province

Florida

ZIP/Postal Code

32405

Country

United States

Facility Name

Research Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Research Site

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33029

Country

United States

Facility Name

Research Site

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

Country

United States

Facility Name

Research Site

City

Pinellas Park

State/Province

Florida

ZIP/Postal Code

33782

Country

United States

Facility Name

Research Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33322

Country

United States

Facility Name

Research Site

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33952

Country

United States

Facility Name

Research Site

City

Port Orange

State/Province

Florida

ZIP/Postal Code

32127

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33704

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33708

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33711

Country

United States

Facility Name

Research Site

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33713

Country

United States

Facility Name

Research Site

City

Santa Rosa Beach

State/Province

Florida

ZIP/Postal Code

32459

Country

United States

Facility Name

Research Site

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Research Site

City

Sebring

State/Province

Florida

ZIP/Postal Code

33870

Country

United States

Facility Name

Research Site

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Research Site

City

Vero Beach

State/Province

Florida

ZIP/Postal Code

32960

Country

United States

Facility Name

Research Site

City

Winter Park

State/Province

Florida

ZIP/Postal Code

32789

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30308

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30310

Country

United States

Facility Name

Research Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Research Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Research Site

City

Duluth

State/Province

Georgia

ZIP/Postal Code

30096

Country

United States

Facility Name

Research Site

City

Johns Creek

State/Province

Georgia

ZIP/Postal Code

30097

Country

United States

Facility Name

Research Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Research Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30066

Country

United States

Facility Name

Research Site

City

Norcross

State/Province

Georgia

ZIP/Postal Code

30092

Country

United States

Facility Name

Research Site

City

Oakwood

State/Province

Georgia

ZIP/Postal Code

30566

Country

United States

Facility Name

Research Site

City

Rincon

State/Province

Georgia

ZIP/Postal Code

31326

Country

United States

Facility Name

Research Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Research Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31419

Country

United States

Facility Name

Research Site

City

Snellville

State/Province

Georgia

ZIP/Postal Code

30039

Country

United States

Facility Name

Research Site

City

Snellville

State/Province

Georgia

ZIP/Postal Code

30078

Country

United States

Facility Name

Research Site

City

Stockbridge

State/Province

Georgia

ZIP/Postal Code

30281

Country

United States

Facility Name

Research Site

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

Research Site

City

Eagle

State/Province

Idaho

ZIP/Postal Code

83616

Country

United States

Facility Name

Research Site

City

Hayden Lake

State/Province

Idaho

ZIP/Postal Code

83835

Country

United States

Facility Name

Research Site

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Research Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Research Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

Research Site

City

Champaign

State/Province

Illinois

ZIP/Postal Code

61820

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Research Site

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Research Site

City

Gillespie

State/Province

Illinois

ZIP/Postal Code

62033

Country

United States

Facility Name

Research Site

City

Melrose Park

State/Province

Illinois

ZIP/Postal Code

60160

Country

United States

Facility Name

Research Site

City

Morton

State/Province

Illinois

ZIP/Postal Code

61550

Country

United States

Facility Name

Research Site

City

Normal

State/Province

Illinois

ZIP/Postal Code

61761

Country

United States

Facility Name

Research Site

City

North Chicago

State/Province

Illinois

ZIP/Postal Code

60064

Country

United States

Facility Name

Research Site

City

O'Fallon

State/Province

Illinois

ZIP/Postal Code

62269

Country

United States

Facility Name

Research Site

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61602

Country

United States

Facility Name

Research Site

City

Avon

State/Province

Indiana

ZIP/Postal Code

46123

Country

United States

Facility Name

Research Site

City

Elwood

State/Province

Indiana

ZIP/Postal Code

46036

Country

United States

Facility Name

Research Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Research Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47715

Country

United States

Facility Name

Research Site

City

Michigan City

State/Province

Indiana

ZIP/Postal Code

46360

Country

United States

Facility Name

Research Site

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47303

Country

United States

Facility Name

Research Site

City

Muncie

State/Province

Indiana

ZIP/Postal Code

47304

Country

United States

Facility Name

Research Site

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Research Site

City

Ames

State/Province

Iowa

ZIP/Postal Code

50010-3014

Country

United States

Facility Name

Research Site

City

Council Bluffs

State/Province

Iowa

ZIP/Postal Code

51503

Country

United States

Facility Name

Research Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Research Site

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

Facility Name

Research Site

City

Pratt

State/Province

Kansas

ZIP/Postal Code

67124

Country

United States

Facility Name

Research Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

Research Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Research Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40218

Country

United States

Facility Name

Research Site

City

Madisonville

State/Province

Kentucky

ZIP/Postal Code

42431

Country

United States

Facility Name

Research Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42303

Country

United States

Facility Name

Research Site

City

Covington

State/Province

Louisiana

ZIP/Postal Code

70433

Country

United States

Facility Name

Research Site

City

Crowley

State/Province

Louisiana

ZIP/Postal Code

70526

Country

United States

Facility Name

Research Site

City

Eunice

State/Province

Louisiana

ZIP/Postal Code

70535

Country

United States

Facility Name

Research Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Research Site

City

Marshall

State/Province

Louisiana

ZIP/Postal Code

75670

Country

United States

Facility Name

Research Site

City

Metairie

State/Province

Louisiana

ZIP/Postal Code

70006

Country

United States

Facility Name

Research Site

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70115

Country

United States

Facility Name

Research Site

City

Opelousas

State/Province

Louisiana

ZIP/Postal Code

70570

Country

United States

Facility Name

Research Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Research Site

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71106

Country

United States

Facility Name

Research Site

City

Slidell

State/Province

Louisiana

ZIP/Postal Code

70458

Country

United States

Facility Name

Research Site

City

Zachary

State/Province

Louisiana

ZIP/Postal Code

70791

Country

United States

Facility Name

Research Site

City

Bangor

State/Province

Maine

ZIP/Postal Code

04401

Country

United States

Facility Name

Research Site

City

Biddeford

State/Province

Maine

ZIP/Postal Code

04005

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

Research Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

Facility Name

Research Site

City

Elkridge

State/Province

Maryland

ZIP/Postal Code

21075

Country

United States

Facility Name

Research Site

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Research Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Research Site

City

Methuen

State/Province

Massachusetts

ZIP/Postal Code

01844

Country

United States

Facility Name

Research Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

Research Site

City

Pittsfield

State/Province

Massachusetts

ZIP/Postal Code

01201

Country

United States

Facility Name

Research Site

City

Bingham Farms

State/Province

Michigan

ZIP/Postal Code

48025

Country

United States

Facility Name

Research Site

City

Buckley

State/Province

Michigan

ZIP/Postal Code

49620

Country

United States

Facility Name

Research Site

City

Caro

State/Province

Michigan

ZIP/Postal Code

48723

Country

United States

Facility Name

Research Site

City

Chesterfield

State/Province

Michigan

ZIP/Postal Code

48047

Country

United States

Facility Name

Research Site

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48336

Country

United States

Facility Name

Research Site

City

Flint

State/Province

Michigan

ZIP/Postal Code

48504

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Michigan

ZIP/Postal Code

48307

Country

United States

Facility Name

Research Site

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Facility Name

Research Site

City

Stevensville

State/Province

Michigan

ZIP/Postal Code

49127

Country

United States

Facility Name

Research Site

City

Troy

State/Province

Michigan

ZIP/Postal Code

48085

Country

United States

Facility Name

Research Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

Research Site

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64128

Country

United States

Facility Name

Research Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64133

Country

United States

Facility Name

Research Site

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63128

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63143

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Missouri

ZIP/Postal Code

65807

Country

United States

Facility Name

Research Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Research Site

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68005

Country

United States

Facility Name

Research Site

City

Fremont

State/Province

Nebraska

ZIP/Postal Code

68025

Country

United States

Facility Name

Research Site

City

Grand Island

State/Province

Nebraska

ZIP/Postal Code

68803

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68510

Country

United States

Facility Name

Research Site

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68124

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68130

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68134

Country

United States

Facility Name

Research Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68144

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89117

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89123

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Research Site

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

Research Site

City

Sparks

State/Province

Nevada

ZIP/Postal Code

89434

Country

United States

Facility Name

Research Site

City

Belvidere

State/Province

New Jersey

ZIP/Postal Code

07823

Country

United States

Facility Name

Research Site

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Research Site

City

East Brunswick

State/Province

New Jersey

ZIP/Postal Code

08816

Country

United States

Facility Name

Research Site

City

Elizabeth

State/Province

New Jersey

ZIP/Postal Code

07201

Country

United States

Facility Name

Research Site

City

Haddon Heights

State/Province

New Jersey

ZIP/Postal Code

08035

Country

United States

Facility Name

Research Site

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Research Site

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Research Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Research Site

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11229

Country

United States

Facility Name

Research Site

City

Buffalo

State/Province

New York

ZIP/Postal Code

14215

Country

United States

Facility Name

Research Site

City

Hopewell Jct

State/Province

New York

ZIP/Postal Code

12533

Country

United States

Facility Name

Research Site

City

Jamaica

State/Province

New York

ZIP/Postal Code

11435

Country

United States

Facility Name

Research Site

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10009

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Research Site

City

Wappingers Falls

State/Province

New York

ZIP/Postal Code

12590

Country

United States

Facility Name

Research Site

City

Westfield

State/Province

New York

ZIP/Postal Code

14787

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

Research Site

City

Burlington

State/Province

North Carolina

ZIP/Postal Code

27215

Country

United States

Facility Name

Research Site

City

Calabash

State/Province

North Carolina

ZIP/Postal Code

28467

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28262

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Facility Name

Research Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Research Site

City

Greensboro

State/Province

North Carolina

ZIP/Postal Code

27405

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

Research Site

City

Hendersonville

State/Province

North Carolina

ZIP/Postal Code

28739

Country

United States

Facility Name

Research Site

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27262

Country

United States

Facility Name

Research Site

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Facility Name

Research Site

City

Lenoir

State/Province

North Carolina

ZIP/Postal Code

28645

Country

United States

Facility Name

Research Site

City

Monroe

State/Province

North Carolina

ZIP/Postal Code

28110

Country

United States

Facility Name

Research Site

City

Monroe

State/Province

North Carolina

ZIP/Postal Code

28112

Country

United States

Facility Name

Research Site

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Facility Name

Research Site

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Facility Name

Research Site

City

Pinehurst

State/Province

North Carolina

ZIP/Postal Code

28374

Country

United States

Facility Name

Research Site

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Research Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Research Site

City

Statesville

State/Province

North Carolina

ZIP/Postal Code

28625

Country

United States

Facility Name

Research Site

City

Tabor City

State/Province

North Carolina

ZIP/Postal Code

28463

Country

United States

Facility Name

Research Site

City

Whiteville

State/Province

North Carolina

ZIP/Postal Code

28472

Country

United States

Facility Name

Research Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27104

Country

United States

Facility Name

Research Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

Research Site

City

Akron

State/Province

Ohio

ZIP/Postal Code

44311

Country

United States

Facility Name

Research Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43207

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45419

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45439

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45459

Country

United States

Facility Name

Research Site

City

Delaware

State/Province

Ohio

ZIP/Postal Code

43015

Country

United States

Facility Name

Research Site

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

Country

United States

Facility Name

Research Site

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45429

Country

United States

Facility Name

Research Site

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Facility Name

Research Site

City

Sylvania

State/Province

Ohio

ZIP/Postal Code

43560

Country

United States

Facility Name

Research Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

Country

United States

Facility Name

Research Site

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Facility Name

Research Site

City

Norman

State/Province

Oklahoma

ZIP/Postal Code

73069

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73120

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74104

Country

United States

Facility Name

Research Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74136

Country

United States

Facility Name

Research Site

City

Yukon

State/Province

Oklahoma

ZIP/Postal Code

73099

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97202

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97210

Country

United States

Facility Name

Research Site

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

Research Site

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

Research Site

City

Belle Vernon

State/Province

Pennsylvania

ZIP/Postal Code

15012

Country

United States

Facility Name

Research Site

City

Bensalem

State/Province

Pennsylvania

ZIP/Postal Code

19020

Country

United States

Facility Name

Research Site

City

Carnegie

State/Province

Pennsylvania

ZIP/Postal Code

15106

Country

United States

Facility Name

Research Site

City

Clairton

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

Facility Name

Research Site

City

Downingtown

State/Province

Pennsylvania

ZIP/Postal Code

19335

Country

United States

Facility Name

Research Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

Research Site

City

Feasterville-Trevose

State/Province

Pennsylvania

ZIP/Postal Code

19053

Country

United States

Facility Name

Research Site

City

Jefferson Hills

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

Facility Name

Research Site

City

Levittown

State/Province

Pennsylvania

ZIP/Postal Code

19056

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19152

Country

United States

Facility Name

Research Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15243

Country

United States

Facility Name

Research Site

City

Scottdale

State/Province

Pennsylvania

ZIP/Postal Code

15683

Country

United States

Facility Name

Research Site

City

Smithfield

State/Province

Pennsylvania

ZIP/Postal Code

15478

Country

United States

Facility Name

Research Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

Research Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Research Site

City

Yardley

State/Province

Pennsylvania

ZIP/Postal Code

19067

Country

United States

Facility Name

Research Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Research Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29412

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Research Site

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

Facility Name

Research Site

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29340

Country

United States

Facility Name

Research Site

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29341

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Research Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Research Site

City

Greer

State/Province

South Carolina

ZIP/Postal Code

29651

Country

United States

Facility Name

Research Site

City

Hodges

State/Province

South Carolina

ZIP/Postal Code

29653

Country

United States

Facility Name

Research Site

City

Indian Land

State/Province

South Carolina

ZIP/Postal Code

29707

Country

United States

Facility Name

Research Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Research Site

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29588

Country

United States

Facility Name

Research Site

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Research Site

City

Pelzer

State/Province

South Carolina

ZIP/Postal Code

29669

Country

United States

Facility Name

Research Site

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Research Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29302

Country

United States

Facility Name

Research Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Research Site

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29485

Country

United States

Facility Name

Research Site

City

Union

State/Province

South Carolina

ZIP/Postal Code

29379

Country

United States

Facility Name

Research Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Research Site

City

Athens

State/Province

Tennessee

ZIP/Postal Code

37303

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

Research Site

City

Fayetteville

State/Province

Tennessee

ZIP/Postal Code

37334

Country

United States

Facility Name

Research Site

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37067

Country

United States

Facility Name

Research Site

City

Hendersonville

State/Province

Tennessee

ZIP/Postal Code

37075

Country

United States

Facility Name

Research Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37919

Country

United States

Facility Name

Research Site

City

Smyrna

State/Province

Tennessee

ZIP/Postal Code

37167

Country

United States

Facility Name

Research Site

City

Spring Hill

State/Province

Tennessee

ZIP/Postal Code

37174

Country

United States

Facility Name

Research Site

City

Tullahoma

State/Province

Tennessee

ZIP/Postal Code

37388

Country

United States

Facility Name

Research Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

Country

United States

Facility Name

Research Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76014

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78759

Country

United States

Facility Name

Research Site

City

Beaumont

State/Province

Texas

ZIP/Postal Code

77702

Country

United States

Facility Name

Research Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Research Site

City

Carrollton

State/Province

Texas

ZIP/Postal Code

75006

Country

United States

Facility Name

Research Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

Research Site

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75220

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75225

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75235

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

Research Site

City

Dickinson

State/Province

Texas

ZIP/Postal Code

77539

Country

United States

Facility Name

Research Site

City

Duncanville

State/Province

Texas

ZIP/Postal Code

75116

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76104

Country

United States

Facility Name

Research Site

City

Fort Worth

State/Province

Texas

ZIP/Postal Code

76107

Country

United States

Facility Name

Research Site

City

Georgetown

State/Province

Texas

ZIP/Postal Code

78626

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77011

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77043

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Research Site

City

Irving

State/Province

Texas

ZIP/Postal Code

75039

Country

United States

Facility Name

Research Site

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Facility Name

Research Site

City

Richardson

State/Province

Texas

ZIP/Postal Code

75080

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78218

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78258

Country

United States

Facility Name

Research Site

City

Spring

State/Province

Texas

ZIP/Postal Code

77379

Country

United States

Facility Name

Research Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77478

Country

United States

Facility Name

Research Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

Research Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Research Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75708

Country

United States

Facility Name

Research Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76710

Country

United States

Facility Name

Research Site

City

Webster

State/Province

Texas

ZIP/Postal Code

77598

Country

United States

Facility Name

Research Site

City

Midvale

State/Province

Utah

ZIP/Postal Code

84047

Country

United States

Facility Name

Research Site

City

Murray

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Research Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

Research Site

City

Riverton

State/Province

Utah

ZIP/Postal Code

84065

Country

United States

Facility Name

Research Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Research Site

City

Abingdon

State/Province

Virginia

ZIP/Postal Code

24210

Country

United States

Facility Name

Research Site

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23114

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23220

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

Research Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23229

Country

United States

Facility Name

Research Site

City

Bellevue

State/Province

Washington

ZIP/Postal Code

98007

Country

United States

Facility Name

Research Site

City

Bellingham

State/Province

Washington

ZIP/Postal Code

98225

Country

United States

Facility Name

Research Site

City

Everett

State/Province

Washington

ZIP/Postal Code

98208

Country

United States

Facility Name

Research Site

City

Port Orchard

State/Province

Washington

ZIP/Postal Code

98366

Country

United States

Facility Name

Research Site

City

Spokane Valley

State/Province

Washington

ZIP/Postal Code

99216

Country

United States

Facility Name

Research Site

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

Research Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25304

Country

United States

Facility Name

Research Site

City

Lewisburg

State/Province

West Virginia

ZIP/Postal Code

24901

Country

United States

Facility Name

Research Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26505

Country

United States

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5A 4L8

Country

Canada

Facility Name

Research Site

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5J 3S9

Country

Canada

Facility Name

Research Site

City

Kamloops

State/Province

British Columbia

ZIP/Postal Code

V2C 5T1

Country

Canada

Facility Name

Research Site

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y 4N7

Country

Canada

Facility Name

Research Site

City

Langley

State/Province

British Columbia

ZIP/Postal Code

V3A 4H9

Country

Canada

Facility Name

Research Site

City

Penticton

State/Province

British Columbia

ZIP/Postal Code

V2A 5C8

Country

Canada

Facility Name

Research Site

City

West Vancouver

State/Province

British Columbia

ZIP/Postal Code

V7T 1E3

Country

Canada

Facility Name

Research Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R2V 4W3

Country

Canada

Facility Name

Research Site

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1A 3R5

Country

Canada

Facility Name

Research Site

City

Bridgewater

State/Province

Nova Scotia

ZIP/Postal Code

B4V 3N2

Country

Canada

Facility Name

Research Site

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3K2M5

Country

Canada

Facility Name

Research Site

City

Ajax

State/Province

Ontario

ZIP/Postal Code

L1Z 0M1

Country

Canada

Facility Name

Research Site

City

Burlington

State/Province

Ontario

ZIP/Postal Code

L7N 3V2

Country

Canada

Facility Name

Research Site

City

Cornwall

State/Province

Ontario

ZIP/Postal Code

K6H 4M4

Country

Canada

Facility Name

Research Site

City

Dorchester

State/Province

Ontario

ZIP/Postal Code

N0L 1G3

Country

Canada

Facility Name

Research Site

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8K 3P3

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N5Z 1R1

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5G6

Country

Canada

Facility Name

Research Site

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 5G8

Country

Canada

Facility Name

Research Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3A 1W8

Country

Canada

Facility Name

Research Site

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 6C3

Country

Canada

Facility Name

Research Site

City

Thorold

State/Province

Ontario

ZIP/Postal Code

L2V 5A7

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3M 0B2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4S 1Y2

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3A9

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9V 4B4

Country

Canada

Facility Name

Research Site

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

Research Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X 5A6

Country

Canada

Facility Name

Research Site

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8X-5A6

Country

Canada

Facility Name

Research Site

City

Longueuil

State/Province

Quebec

ZIP/Postal Code

J4N 1C2

Country

Canada

Facility Name

Research Site

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1M 1B1

Country

Canada

Facility Name

Research Site

City

St Charles Borromee

State/Province

Quebec

ZIP/Postal Code

J6E 2B4

Country

Canada

Facility Name

Research Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7H 5M3

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1G 3Y8

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G3K 2P8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

34686204

Citation

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.

Results Reference

derived

PubMed Identifier

34528220

Citation

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.

Results Reference

derived

PubMed Identifier

33776428

Citation

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.

Results Reference

derived

PubMed Identifier

31063575

Citation

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.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4001&filename=AZ-D6560C00002-PXL226451-CSP-amendment5-redacted-Final-31Aug2018_PDFA.pdf

Description

Protocol

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4001&filename=AZ-D6560C00002-PXL226451-SAP-redacted-Final-31Aug2018_PDFA.pdf

Description

Statistical Analysis Plan (SAP)

Learn more about this trial

Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.

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Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients. (ASCENT COPD)

COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial