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Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

NCT ID: NCT01437540

Last Updated: 2017-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

590 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-19

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol in patients with moderate to severe, stable chronic obstructive pulmonary disease (COPD).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg fixed dose combination (FDC), high dose twice per day

Group Type EXPERIMENTAL

Aclidinium Bromide/Formoterol Fumarate

Intervention Type DRUG

Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day

2

Inhaled formoterol fumarate 12 μg, twice per day

Group Type ACTIVE_COMPARATOR

Formoterol Fumarate

Intervention Type DRUG

Inhaled formoterol fumarate 12 μg, twice per day

Interventions

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Aclidinium Bromide/Formoterol Fumarate

Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day

Intervention Type DRUG

Formoterol Fumarate

Inhaled formoterol fumarate 12 μg, twice per day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current or former cigarette smokers with a cigarette smoking history of at least 10 pack-years
* A diagnosis of stable moderate to severe COPD and stable airway obstruction as defined by the Global Initiative for Chronic Obstructive Lung Disease guidelines and stable airway obstruction.

Exclusion Criteria

* Patients who have been hospitalized for an acute COPD exacerbation within three months prior to Visit 1
* Any respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the six weeks before Visit 1.
* Patients with any clinically significant respiratory conditions other than COPD
* Clinical history that suggests that the patient has asthma as opposed to COPD
* Chronic use of oxygen therapy ≥ 15 hours/day
* Patients with clinically significant cardiovascular conditions
* Patients with uncontrolled infection that may place the patient at risk resulting from human immunodeficiency virus (HIV), active hepatitis and/or patients with diagnosed active tuberculosis
* Patients with a history of hypersensitivity reaction to inhaled anticholinergics,
* Patients with Stage II hypertension, defined as systolic pressure of 160 and above, and/or diastolic pressure of 100 and above
* Current diagnosis of cancer other than basal or squamous cell skin cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Esther Garcia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Forest Investigative Site 1162

Birmingham, Alabama, United States

Site Status

Forest Investigative Site 1493

Birmingham, Alabama, United States

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Forest Investigative Site 1620

Birmingham, Alabama, United States

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Forest Investigative Site 1127

Mobile, Alabama, United States

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Forest Investigative Site 1613

Chandler, Arizona, United States

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Forest Investigative Site 1623

Peoria, Arizona, United States

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Forest Investigative Site 1582

Phoenix, Arizona, United States

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Forest Investigative Site 1379

Phoenix, Arizona, United States

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Forest Investigative Site 1581

Phoenix, Arizona, United States

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Forest Investigative Site 1571

Phoenix, Arizona, United States

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Forest Investigative Site 1596

Fort Smith, Arkansas, United States

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Forest Investigative Site 1547

Encinitas, California, United States

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Forest Investigative Site 1088

Lakewood, California, United States

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Forest Investigative Site 1624

Los Angeles, California, United States

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Forest Investigative Site 1927

Los Angeles, California, United States

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Forest Investigative Site 1388

Paramount, California, United States

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Forest Investigative Site 1503

San Diego, California, United States

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Forest Investigative Site 1374

Torrance, California, United States

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Forest Investigative Site 1331

Vista, California, United States

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Forest Investigative Site 2039

Walnut Creek, California, United States

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Forest Investigative Site 1597

Boulder, Colorado, United States

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Forest Investigative Site 1137

Colorado Springs, Colorado, United States

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Forest Investigative Site 0892

Denver, Colorado, United States

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Forest Investigative Site 2037

Fort Collins, Colorado, United States

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Forest Investigative Site 1327

Wheat Ridge, Colorado, United States

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Forest Investigative Site 2045

Wheat Ridge, Colorado, United States

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Forest Investigative Site 1589

Norwalk, Connecticut, United States

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Forest Investigative Site 1598

Stamford, Connecticut, United States

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Forest Investigative Site 1154

Brandon, Florida, United States

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Forest Investigative Site 1944

Brandon, Florida, United States

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Forest Investigative Site 1152

Clearwater, Florida, United States

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Forest Investigative Site 1617

DeBary, Florida, United States

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Forest Investigative Site 1959

DeBary, Florida, United States

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Forest Investigative Site 1516

Edgewater, Florida, United States

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Forest Investigative Site 1403

Hollywood, Florida, United States

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Forest Investigative Site 1556

Orlando, Florida, United States

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Forest Investigative Site 1542

Ormond Beach, Florida, United States

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Forest Investigative Site 0974

Pensacola, Florida, United States

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Forest Investigative Site 2047

Tampa, Florida, United States

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Forest Investigative Site 1565

Venice, Florida, United States

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Forest Investigative Site 1851

Atlanta, Georgia, United States

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Forest Investigative Site 0980

Atlanta, Georgia, United States

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Forest Investigative Site 1567

Atlanta, Georgia, United States

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Forest Investigative Site 1607

Lawrenceville, Georgia, United States

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Forest Investigative Site 1409

O'Fallon, Illinois, United States

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Forest Investigative Site 2051

River Forest, Illinois, United States

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Forest Investigative Site 1604

Springfield, Illinois, United States

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Forest Investigative Site 1576

Evansville, Indiana, United States

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Forest Investigative Site 1549

Council Bluffs, Iowa, United States

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Forest Investigative Site 2033

Bowling Green, Kentucky, United States

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Forest Investigative Site 2085

Crescent Springs, Kentucky, United States

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Forest Investigative Site 1336

Louisville, Kentucky, United States

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Forest Investigative Site 2024

Lafayette, Louisiana, United States

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Forest Investigative Site 1430

New Orleans, Louisiana, United States

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Forest Investigative Site 1360

Sunset, Louisiana, United States

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Forest Investigative Site 1566

Auburn, Maine, United States

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Forest Investigative Site 1333

Baltimore, Maryland, United States

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Forest Investigative Site 1622

Columbia, Maryland, United States

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Forest Investigative Site 1590

Towson, Maryland, United States

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Forest Investigative Site 1570

Fall River, Massachusetts, United States

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Forest Investigative Site 1546

Haverhill, Massachusetts, United States

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Forest Investigative Site 1029

North Dartmouth, Massachusetts, United States

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Forest Investigative Site 1595

Worcestor, Massachusetts, United States

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Forest Investigative Site 1605

Traverse City, Michigan, United States

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Forest Investigative Site 1527

Fridley, Minnesota, United States

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Forest Investigative Site 1124

Minneapolis, Minnesota, United States

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Forest Investigative Site 1619

Plymouth, Minnesota, United States

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Forest Investigative Site 1587

Chesterfield, Missouri, United States

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Forest Investigative Site 1572

Jefferson City, Missouri, United States

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Forest Investigative Site 1399

St Louis, Missouri, United States

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Forest Investigative Site 1599

St Louis, Missouri, United States

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Forest Investigative Site 1831

Bozeman, Montana, United States

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Forest Investigative Site 1400

Missoula, Montana, United States

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Forest Investigative Site 1609

Bellevue, Nebraska, United States

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Forest Investigative Site 1616

Lincoln, Nebraska, United States

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Forest Investigative Site 1615

Omaha, Nebraska, United States

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Forest Investigative Site 1562

Las Vegas, Nevada, United States

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Forest Investigative Site 1610

Rochester, New Hampshire, United States

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Forest Investigative Site 1558

Brick, New Jersey, United States

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Forest Investigative Site 1559

Cherry Hill, New Jersey, United States

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Forest Investigative Site 1394

Ocean City, New Jersey, United States

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Forest Investigative Site 2084

Summit, New Jersey, United States

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Forest Investigative Site 0972

Brooklyn, New York, United States

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Forest Investigative Site 1163

New York, New York, United States

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Forest Investigative Site 1425

New York, New York, United States

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Forest Investigative Site 1554

Newburgh, New York, United States

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Forest Investigative Site 1563

Syracuse, New York, United States

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Forest Investigative Site 1557

Raleigh, North Carolina, United States

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Forest Investigative Site 1588

Shelby, North Carolina, United States

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Forest Investigative Site 1553

Wilmington, North Carolina, United States

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Forest Investigative Site 1550

Winston-Salem, North Carolina, United States

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Forest Investigative Site 1134

Canton, Ohio, United States

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Forest Investigative Site 1594

Cincinnati, Ohio, United States

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Forest Investigative Site 2028

Cincinnati, Ohio, United States

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Forest Investigative Site 1541

Marion, Ohio, United States

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Forest Investigative Site 1530

Toledo, Ohio, United States

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Forest Investigative Site 1393

Zanesville, Ohio, United States

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Forest Investigative Site 1612

Ashland, Oregon, United States

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Forest Investigative Site 1575

Corvallis, Oregon, United States

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Forest Investigative Site 1081

Eugene, Oregon, United States

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Forest Investigative Site 1580

Portland, Oregon, United States

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Forest Investigative Site 1552

Portland, Oregon, United States

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Forest Investigative Site 1574

Beaver, Pennsylvania, United States

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Forest Investigative Site 1577

Beaver, Pennsylvania, United States

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Forest Investigative Site 1126

Bethlehem, Pennsylvania, United States

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Forest Investigative Site 1423

Erie, Pennsylvania, United States

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Forest Investigative Site 1504

Hershey, Pennsylvania, United States

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Forest Investigative Site 1569

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 1548

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 1146

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 1560

Pittsburgh, Pennsylvania, United States

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Forest Investigative Site 1449

Tipton, Pennsylvania, United States

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Forest Investigative Site 1564

Uniontown, Pennsylvania, United States

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Forest Investigative Site 1144

Johnston, Rhode Island, United States

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Forest Investigative Site 2072

Charleston, South Carolina, United States

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Forest Investigative Site 1568

Easley, South Carolina, United States

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Forest Investigative Site 1506

Greenville, South Carolina, United States

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Forest Investigative Site 1601

Greer, South Carolina, United States

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Forest Investigative Site 0900

Spartanburg, South Carolina, United States

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Forest Investigative Site 1450

Union, South Carolina, United States

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Forest Investigative Site 1365

Rapid City, South Dakota, United States

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Forest Investigative Site 1440

Arlington, Texas, United States

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Forest Investigative Site 1954

Austin, Texas, United States

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Forest Investigative Site 1155

Dallas, Texas, United States

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Forest Investigative Site 1328

Dallas, Texas, United States

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Forest Investigative Site 1332

El Paso, Texas, United States

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Forest Investigative Site 2012

Fort Worth, Texas, United States

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Forest Investigative Site 1902

Killeen, Texas, United States

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Forest Investigative Site 1498

San Antonio, Texas, United States

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Forest Investigative Site 1614

San Antonio, Texas, United States

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Forest Investigative Site 1906

San Antonio, Texas, United States

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Forest Investigative Site 2004

San Antonio, Texas, United States

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Forest Investigative Site 1600

Magna, Utah, United States

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Forest Investigative Site 1480

Abingdon, Virginia, United States

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Forest Investigative Site 1579

Alexandria, Virginia, United States

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Forest Investigative Site 1142

Spokane, Washington, United States

Site Status

Forest Investigative Site 1573

Spokane, Washington, United States

Site Status

Countries

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United States

References

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Donohue JF, Soong W, Wu X, Shrestha P, Lei A. Long-term safety of aclidinium bromide/formoterol fumarate fixed-dose combination: Results of a randomized 1-year trial in patients with COPD. Respir Med. 2016 Jul;116:41-8. doi: 10.1016/j.rmed.2016.05.007. Epub 2016 May 7.

Reference Type DERIVED
PMID: 27296819 (View on PubMed)

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4061&filename=lac-md-32-synopsis.pdf

lac-md-32-synopsis

Other Identifiers

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LAC-MD-32

Identifier Type: -

Identifier Source: org_study_id

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