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

NCT01437540 | Completed Phase 3 Results DMC

• 1 other identifier: LAC-MD-32
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 137

Brief Summary

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)

  TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)

  Up to study Week 56 ± 3 days

Secondary Outcomes (3)

• Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study

  Up to study Week 52

• Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure

  Up to study Week 56 ± 3 days

• Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline

  Up to study Week 56 ± 3 days

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Aclidinium Bromide/Formoterol Fumarate

2

ACTIVE COMPARATOR

Inhaled formoterol fumarate 12 μg, twice per day

Drug: Formoterol Fumarate

Interventions

Aclidinium Bromide/Formoterol Fumarate DRUG

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

1

Formoterol Fumarate DRUG

Inhaled formoterol fumarate 12 μg, twice per day

2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (137)

Forest Investigative Site 1162

Birmingham, Alabama, 35209, United States

Location

Forest Investigative Site 1493

Birmingham, Alabama, 35209, United States

Location

Forest Investigative Site 1620

Birmingham, Alabama, 35235, United States

Location

Forest Investigative Site 1127

Mobile, Alabama, 36608, United States

Location

Forest Investigative Site 1613

Chandler, Arizona, 85224, United States

Location

Forest Investigative Site 1623

Peoria, Arizona, 85381, United States

Location

Forest Investigative Site 1582

Phoenix, Arizona, 85012, United States

Location

Forest Investigative Site 1379

Phoenix, Arizona, 85018, United States

Location

Forest Investigative Site 1581

Phoenix, Arizona, 85020, United States

Location

Forest Investigative Site 1571

Phoenix, Arizona, 85050, United States

Location

Forest Investigative Site 1596

Fort Smith, Arkansas, 72901, United States

Location

Forest Investigative Site 1547

Encinitas, California, 92024, United States

Location

Forest Investigative Site 1088

Lakewood, California, 90712, United States

Location

Forest Investigative Site 1624

Los Angeles, California, 90025, United States

Location

Forest Investigative Site 1927

Los Angeles, California, 90048, United States

Location

Forest Investigative Site 1388

Paramount, California, 90723, United States

Location

Forest Investigative Site 1503

San Diego, California, 92128, United States

Location

Forest Investigative Site 1374

Torrance, California, 90505, United States

Location

Forest Investigative Site 1331

Vista, California, 92083, United States

Location

Forest Investigative Site 2039

Walnut Creek, California, 94598, United States

Location

Forest Investigative Site 1597

Boulder, Colorado, 80304, United States

Location

Forest Investigative Site 1137

Colorado Springs, Colorado, 80907, United States

Location

Forest Investigative Site 0892

Denver, Colorado, 80206, United States

Location

Forest Investigative Site 2037

Fort Collins, Colorado, 80528, United States

Location

Forest Investigative Site 1327

Wheat Ridge, Colorado, 80033, United States

Location

Forest Investigative Site 2045

Wheat Ridge, Colorado, 80033, United States

Location

Forest Investigative Site 1589

Norwalk, Connecticut, 06851, United States

Location

Forest Investigative Site 1598

Stamford, Connecticut, 06902, United States

Location

Forest Investigative Site 1154

Brandon, Florida, 33511, United States

Location

Forest Investigative Site 1944

Brandon, Florida, 33511, United States

Location

Forest Investigative Site 1152

Clearwater, Florida, 33765, United States

Location

Forest Investigative Site 1617

DeBary, Florida, 32713, United States

Location

Forest Investigative Site 1959

DeBary, Florida, 32713, United States

Location

Forest Investigative Site 1516

Edgewater, Florida, 32132, United States

Location

Forest Investigative Site 1403

Hollywood, Florida, 33024, United States

Location

Forest Investigative Site 1556

Orlando, Florida, 32822, United States

Location

Forest Investigative Site 1542

Ormond Beach, Florida, 32174, United States

Location

Forest Investigative Site 0974

Pensacola, Florida, 32504, United States

Location

Forest Investigative Site 2047

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 1565

Venice, Florida, 34292, United States

Location

Forest Investigative Site 1851

Atlanta, Georgia, 30329, United States

Location

Forest Investigative Site 0980

Atlanta, Georgia, 30342, United States

Location

Forest Investigative Site 1567

Atlanta, Georgia, 30342, United States

Location

Forest Investigative Site 1607

Lawrenceville, Georgia, 30046, United States

Location

Forest Investigative Site 1409

O'Fallon, Illinois, 62269, United States

Location

Forest Investigative Site 2051

River Forest, Illinois, 60305, United States

Location

Forest Investigative Site 1604

Springfield, Illinois, 62702, United States

Location

Forest Investigative Site 1576

Evansville, Indiana, 47713, United States

Location

Forest Investigative Site 1549

Council Bluffs, Iowa, 51503, United States

Location

Forest Investigative Site 2033

Bowling Green, Kentucky, 42101, United States

Location

Forest Investigative Site 2085

Crescent Springs, Kentucky, 41017, United States

Location

Forest Investigative Site 1336

Louisville, Kentucky, 40215, United States

Location

Forest Investigative Site 2024

Lafayette, Louisiana, 70503, United States

Location

Forest Investigative Site 1430

New Orleans, Louisiana, 70115, United States

Location

Forest Investigative Site 1360

Sunset, Louisiana, 70584, United States

Location

Forest Investigative Site 1566

Auburn, Maine, 04210, United States

Location

Forest Investigative Site 1333

Baltimore, Maryland, 21236, United States

Location

Forest Investigative Site 1622

Columbia, Maryland, 21044, United States

Location

Forest Investigative Site 1590

Towson, Maryland, 21204, United States

Location

Forest Investigative Site 1570

Fall River, Massachusetts, 02720, United States

Location

Forest Investigative Site 1546

Haverhill, Massachusetts, 01830, United States

Location

Forest Investigative Site 1029

North Dartmouth, Massachusetts, 02747, United States

Location

Forest Investigative Site 1595

Worcestor, Massachusetts, 01605, United States

Location

Forest Investigative Site 1605

Traverse City, Michigan, 49684, United States

Location

Forest Investigative Site 1527

Fridley, Minnesota, 55432, United States

Location

Forest Investigative Site 1124

Minneapolis, Minnesota, 55407, United States

Location

Forest Investigative Site 1619

Plymouth, Minnesota, 55441, United States

Location

Forest Investigative Site 1587

Chesterfield, Missouri, 63017, United States

Location

Forest Investigative Site 1572

Jefferson City, Missouri, 65109, United States

Location

Forest Investigative Site 1399

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 1599

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 1831

Bozeman, Montana, 59718, United States

Location

Forest Investigative Site 1400

Missoula, Montana, 59808, United States

Location

Forest Investigative Site 1609

Bellevue, Nebraska, 68123, United States

Location

Forest Investigative Site 1616

Lincoln, Nebraska, 68506, United States

Location

Forest Investigative Site 1615

Omaha, Nebraska, 68134, United States

Location

Forest Investigative Site 1562

Las Vegas, Nevada, 89183, United States

Location

Forest Investigative Site 1610

Rochester, New Hampshire, 03867, United States

Location

Forest Investigative Site 1558

Brick, New Jersey, 08723, United States

Location

Forest Investigative Site 1559

Cherry Hill, New Jersey, 08003, United States

Location

Forest Investigative Site 1394

Ocean City, New Jersey, 07712, United States

Location

Forest Investigative Site 2084

Summit, New Jersey, 07901, United States

Location

Forest Investigative Site 0972

Brooklyn, New York, 11229, United States

Location

Forest Investigative Site 1163

New York, New York, 10016, United States

Location

Forest Investigative Site 1425

New York, New York, 10028, United States

Location

Forest Investigative Site 1554

Newburgh, New York, 12550, United States

Location

Forest Investigative Site 1563

Syracuse, New York, 13210, United States

Location

Forest Investigative Site 1557

Raleigh, North Carolina, 27612, United States

Location

Forest Investigative Site 1588

Shelby, North Carolina, 28152, United States

Location

Forest Investigative Site 1553

Wilmington, North Carolina, 28401, United States

Location

Forest Investigative Site 1550

Winston-Salem, North Carolina, 27103, United States

Location

Forest Investigative Site 1134

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 1594

Cincinnati, Ohio, 45224, United States

Location

Forest Investigative Site 2028

Cincinnati, Ohio, 45242, United States

Location

Forest Investigative Site 1541

Marion, Ohio, 43302, United States

Location

Forest Investigative Site 1530

Toledo, Ohio, 43608, United States

Location

Forest Investigative Site 1393

Zanesville, Ohio, 43701, United States

Location

Forest Investigative Site 1612

Ashland, Oregon, 97520, United States

Location

Forest Investigative Site 1575

Corvallis, Oregon, 97330, United States

Location

Forest Investigative Site 1081

Eugene, Oregon, 97404, United States

Location

Forest Investigative Site 1580

Portland, Oregon, 97213, United States

Location

Forest Investigative Site 1552

Portland, Oregon, 97220, United States

Location

Forest Investigative Site 1574

Beaver, Pennsylvania, 15009, United States

Location

Forest Investigative Site 1577

Beaver, Pennsylvania, 15009, United States

Location

Forest Investigative Site 1126

Bethlehem, Pennsylvania, 18020, United States

Location

Forest Investigative Site 1423

Erie, Pennsylvania, 16506, United States

Location

Forest Investigative Site 1504

Hershey, Pennsylvania, 17033, United States

Location

Forest Investigative Site 1569

Pittsburgh, Pennsylvania, 15213, United States

Location

Forest Investigative Site 1548

Pittsburgh, Pennsylvania, 15236, United States

Location

Forest Investigative Site 1146

Pittsburgh, Pennsylvania, 15243, United States

Location

Forest Investigative Site 1560

Pittsburgh, Pennsylvania, 15243, United States

Location

Forest Investigative Site 1449

Tipton, Pennsylvania, 16684, United States

Location

Forest Investigative Site 1564

Uniontown, Pennsylvania, 15401, United States

Location

Forest Investigative Site 1144

Johnston, Rhode Island, 02919, United States

Location

Forest Investigative Site 2072

Charleston, South Carolina, 29406, United States

Location

Forest Investigative Site 1568

Easley, South Carolina, 29640, United States

Location

Forest Investigative Site 1506

Greenville, South Carolina, 29615, United States

Location

Forest Investigative Site 1601

Greer, South Carolina, 29651, United States

Location

Forest Investigative Site 0900

Spartanburg, South Carolina, 29303, United States

Location

Forest Investigative Site 1450

Union, South Carolina, 29379, United States

Location

Forest Investigative Site 1365

Rapid City, South Dakota, 57702, United States

Location

Forest Investigative Site 1440

Arlington, Texas, 76012, United States

Location

Forest Investigative Site 1954

Austin, Texas, 78731, United States

Location

Forest Investigative Site 1155

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 1328

Dallas, Texas, 75231, United States

Location

Forest Investigative Site 1332

El Paso, Texas, 79903, United States

Location

Forest Investigative Site 2012

Fort Worth, Texas, 76104, United States

Location

Forest Investigative Site 1902

Killeen, Texas, 76543, United States

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Forest Investigative Site 1498

San Antonio, Texas, 78215, United States

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Forest Investigative Site 1614

San Antonio, Texas, 78228, United States

Location

Forest Investigative Site 1906

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 2004

San Antonio, Texas, 78229, United States

Location

Forest Investigative Site 1600

Magna, Utah, 84044, United States

Location

Forest Investigative Site 1480

Abingdon, Virginia, 24210, United States

Location

Forest Investigative Site 1579

Alexandria, Virginia, 22304, United States

Location

Forest Investigative Site 1142

Spokane, Washington, 99204, United States

Location

Forest Investigative Site 1573

Spokane, Washington, 99216, United States

Location

Related Publications (1)

• 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.

  PMID: 27296819 DERIVED

Related Links

• lac-md-32-synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

aclidinium bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Limitations and Caveats

The objective of the study is to assess the long-term safety and tolerability of inhaled aclidinium bromide/formoterol fixed-dose combination (FDC) Therefore there were were no primary and secondary efficacy assessments

Results Point of Contact

• Title: Study Director
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Esther Garcia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: September 21, 2011
• Study Start: September 19, 2011
• Primary Completion: March 31, 2013
• Study Completion: April 30, 2013
• Last Updated: May 11, 2017
• Results First Posted: May 11, 2017

Record last verified: 2017-03

Locations

US (137)