Efficacy, Safety, and Tolerability of Aclidinium Bromide in the Treatment of Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-38)

NCT01045161 | Completed Phase 3 Results

• 1 other identifier: LAS-MD-38
• Study Type: interventional
• Target: 544
• Locations: 2 countries
• Sites: 112

Brief Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of aclidinium bromide doses compared with placebo in the treatment of moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week run-in period followed by a 12-week double-blind, placebo-controlled treatment period. This will be followed by an open-label 40-week treatment period and a 2-week follow up phone call. All patients will receive the higher Aclidinium Bromide during the 40-week open label treatment period.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema; Airflow Obstruction, Chronic; Chronic Airflow Obstruction; Chronic Obstructive Airway Disease; Chronic Obstructive Lung Disease

Outcome Measures

Primary Outcomes (2)

• Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)

  Change from baseline in Trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF)

  Change from baseline (Week 0) to Week 12

• Part B: Morning Predose (Trough) FEV1

  Change from Baseline in Morning Pre-dose (trough) Forced Expiratory Volume in 1 Second (FEV1) at Week 52, Lost Observation Carried Forward (LOCF)

  Change from baseline (Week 0) to 52 Weeks

Secondary Outcomes (2)

• Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)

  Change from baseline (Week 0) to Week 12

• Part B: Peak FEV1

  Change from baseline (Week 0) to 52 Weeks

Study Arms (3)

1

EXPERIMENTAL

Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks

Drug: Aclidinium bromide

2

EXPERIMENTAL

Aclidinium bromide 400 μg dose twice per day, inhaled for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg will continue to receive open label 400µg aclidinium bromide for 40 weeks

Drug: Aclidinium bromide

3

PLACEBO COMPARATOR

Dose-match placebo, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on placebo will receive open label 400µg aclidinium bromide for 40 weeks

Drug: Placebo

Interventions

Aclidinium bromide DRUG

Aclidinium bromide 200 μg, oral inhalation twice per day 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg will receive open label 400µg aclidinium bromide for 40 weeks of treatment.

1; 2

Placebo DRUG

Dose-matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo will receive open label 400 µg aclidinium bromide for 40 weeks of treatment

3

Eligibility Criteria

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

You may qualify if:

• A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2008; postbronchodilator FEV1/FVC \< 70%, and postbronchodilator FEV1 ≥ 30% and \< 80% predicted
• Current or former cigarette smokers

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (112)

Forest Investigative Site 1493

Birmingham, Alabama, 35209, United States

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Forest Investigative Site 1419

Birmingham, Alabama, 35233, United States

Location

Forest Investigative Site 1413

Muscle Shoals, Alabama, 35662, United States

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Forest Investigative Site 1353

Pell City, Alabama, 35128, United States

Location

Forest Investigative Site 1379

Phoenix, Arizona, 85018, United States

Location

Forest Investigative Site 2065

Fullerton, California, 92835, United States

Location

Forest Investigative Site 1451

National City, California, 91950, United States

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Forest Investigative Site 1388

Paramount, California, 90723, United States

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Forest Investigative Site 1424

Rolling Hill Estates, California, 90274, United States

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Forest Investigative Site 1427

Sacramento, California, 95817, United States

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Forest Investigative Site 1418

San Diego, California, 92120, United States

Location

Forest Investigative Site 2009

San Diego, California, 92120, United States

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Forest Investigative Site 1374

Torrance, California, 90505, United States

Location

Forest Investigative Site 1331

Vista, California, 92083, United States

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Forest Investigative Site 1380

Golden, Colorado, 80401, United States

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Forest Investigative Site 1447

Pueblo, Colorado, 81001, United States

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Forest Investigative Site 1364

Clearwater, Florida, 33756, United States

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Forest Investigative Site 1516

Edgewater, Florida, 32132, United States

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Forest Investigative Site 1403

Hollywood, Florida, 33021, United States

Location

Forest Investigative Site 1485

Homestead, Florida, 33032, United States

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Forest Investigative Site 1352

Miami, Florida, 33126, United States

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Forest Investigative Site 1391

Naples, Florida, 34110, United States

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Forest Investigative Site 1376

Port Orange, Florida, 32129, United States

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Forest Investigative Site 1372

South Miami, Florida, 33143, United States

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Forest Investigative Site 1407

Trinity, Florida, 34655, United States

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Forest Investigative Site 1185

Winter Park, Florida, 32789, United States

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Forest Investigative Site 1386

Atlanta, Georgia, 30328, United States

Location

Forest Investigative Site 1411

Calhoun, Georgia, 30701, United States

Location

Forest Investigative Site 1528

Lawrenceville, Georgia, 30046, United States

Location

Forest Investigative Site 0679

Coeur d'Alene, Idaho, 83814, United States

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Forest Investigative Site 1385

Elk Grove Village, Illinois, 60007, United States

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Forest Investigative Site 1409

O'Fallon, Illinois, 62269, United States

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Forest Investigative Site 1479

Anderson, Indiana, 46011, United States

Location

Forest Investigative Site 2022

Evansville, Indiana, 47714, United States

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Forest Investigative Site 1441

Indianapolis, Indiana, 46256, United States

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Forest Investigative Site 1149

South Bend, Indiana, 46617, United States

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Forest Investigative Site 1406

Iowa City, Iowa, 52240, United States

Location

Forest Investigative Site 1080

Topeka, Kansas, 66606, United States

Location

Forest Investigative Site 2033

Bowling Green, Kentucky, 42101, United States

Location

Forest Investigative Site 1090

Hazard, Kentucky, 41701, United States

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Forest Investigative Site 1430

New Orleans, Louisiana, 70115, United States

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Forest Investigative Site 1446

New Orleans, Louisiana, 70119, United States

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Forest Investigative Site 1360

Sunset, Louisiana, 70584, United States

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Forest Investigative Site 1412

Baltimore, Maryland, 21201, United States

Location

Forest Investigative Site 1518

North East, Maryland, 21901, United States

Location

Forest Investigative Site 1442

Brockton, Massachusetts, 02301, United States

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Forest Investigative Site 1421

Fall River, Massachusetts, 02720, United States

Location

Forest Investigative Site 1029

North Dartmouth, Massachusetts, 02747, United States

Location

Forest Investigative Site 1405

Chelsea, Michigan, 48118, United States

Location

Forest Investigative Site 0889

Livonia, Michigan, 48152, United States

Location

Forest Investigative Site 1487

Troy, Michigan, 48085, United States

Location

Forest Investigative Site 1128

Edina, Minnesota, 58435, United States

Location

Forest Investigative Site 1527

Fridley, Minnesota, 55432, United States

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Forest Investigative Site 1124

Minneapolis, Minnesota, 55403, United States

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Forest Investigative Site 1118

Rochester, Minnesota, 55904, United States

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Forest Investigative Site 1399

St Louis, Missouri, 63141, United States

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Forest Investigative Site 1400

Missoula, Montana, 59808, United States

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Forest Investigative Site 1354

Bellevue, Nebraska, 68005, United States

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Forest Investigative Site 1367

Bellevue, Nebraska, 68123, United States

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Forest Investigative Site 1476

Fremont, Nebraska, 68025, United States

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Forest Investigative Site 1363

Omaha, Nebraska, 68114, United States

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Forest Investigative Site 1390

Omaha, Nebraska, 68130, United States

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Forest Investigative Site 1422

Omaha, Nebraska, 68134, United States

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Forest Investigative Site 1359

Henderson, Nevada, 89014, United States

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Forest Investigative Site 1355

Las Vegas, Nevada, 89123, United States

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Forest Investigative Site 1486

Albuquerque, New Mexico, 87108, United States

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Forest Investigative Site 1489

Larchmont, New York, 10538, United States

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Forest Investigative Site 1425

New York, New York, 10028, United States

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Forest Investigative Site 1373

North Syracuse, New York, 13212, United States

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Forest Investigative Site 1392

Charlotte, North Carolina, 28277, United States

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Forest Investigative Site 1366

High Point, North Carolina, 27262, United States

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Forest Investigative Site 1136

Cincinnati, Ohio, 45227, United States

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Forest Investigative Site 1371

Cincinnati, Ohio, 45245, United States

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Forest Investigative Site 1361

Columbus, Ohio, 43209, United States

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Forest Investigative Site 1433

Columbus, Ohio, 43213, United States

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Forest Investigative Site 1530

Toledo, Ohio, 43608, United States

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Forest Investigative Site 1393

Zanesville, Ohio, 43701, United States

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Forest Investigative Site 1362

Oklahoma City, Oklahoma, 73112, United States

Location

Forest Investigative Site 2018

Medford, Oregon, 97504, United States

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Forest Investigative Site 2043

Medford, Oregon, 97504, United States

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Forest Investigative Site 1377

Collegeville, Pennsylvania, 19426, United States

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Forest Investigative Site 1423

Erie, Pennsylvania, 16508, United States

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Forest Investigative Site 1428

Feasterville, Pennsylvania, 19053, United States

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Forest Investigative Site 1443

Philadelphia, Pennsylvania, 19107, United States

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Forest Investigative Site 1510

Pittsburgh, Pennsylvania, 15221, United States

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Forest Investigative Site 1449

Tipton, Pennsylvania, 16684, United States

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Forest Investigative Site 1445

Johnston, Rhode Island, 02919, United States

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Forest Investigative Site 1477

Lincoln, Rhode Island, 02865, United States

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Forest Investigative Site 1144

Columbia, South Carolina, 29201, United States

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Forest Investigative Site 1517

Easley, South Carolina, 29640, United States

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Forest Investigative Site 1506

Grenville, South Carolina, 29615, United States

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Forest Investigative Site 1450

Union, South Carolina, 29379, United States

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Forest Investigative Site 1526

Fayetteville, Tennessee, 37337, United States

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Forest Investigative Site 1356

Knoxville, Tennessee, 37909, United States

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Forest Investigative Site 1417

Knoxville, Tennessee, 37920, United States

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Forest Investigative Site 1389

Amarillo, Texas, 79106, United States

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Forest Investigative Site 1440

Arlington, Texas, 76012, United States

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Forest Investigative Site 1494

Austin, Texas, 78756, United States

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Forest Investigative Site 1375

Houston, Texas, 77074, United States

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Forest Investigative Site 1444

Houston, Texas, 77079, United States

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Forest Investigative Site 1401

Houston, Texas, 77083, United States

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Forest Investigative Site 1381

Houston, Texas, 77479, United States

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Forest Investigative Site 1357

Hurst, Texas, 76054, United States

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Forest Investigative Site 1426

Plano, Texas, 75093, United States

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Forest Investigative Site 1410

Tomball, Texas, 77375, United States

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Forest Investigative Site 1480

Abingdon, Virginia, 24210, United States

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Forest Investigative Site 1402

Lynchburg, Virginia, 24501, United States

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Forest Investigative Site 1404

Norfolk, Virginia, 23502, United States

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Forest Investigative Site 1358

Richmond, Virginia, 23294, United States

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Forest Investigative Site 0988

Tacoma, Washington, 98405, United States

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Forest Investigative Site 1177

Vancouver, British Columbia, V5Z 4E1, Canada

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Forest Investigative Site 0969

Windsor, Ontario, N8X 5A6, Canada

Location

Related Publications (1)

• Rennard SI, Scanlon PD, Ferguson GT, Rekeda L, Maurer BT, Garcia Gil E, Caracta CF. ACCORD COPD II: a randomized clinical trial to evaluate the 12-week efficacy and safety of twice-daily aclidinium bromide in chronic obstructive pulmonary disease patients. Clin Drug Investig. 2013 Dec;33(12):893-904. doi: 10.1007/s40261-013-0138-1.

  PMID: 24085591 DERIVED

Related Links

• las-md-38-synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

aclidinium bromide

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

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

Study Officials

• Esther Garcia, Ph. D.

  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: January 7, 2010
• First Posted: January 8, 2010
• Study Start: March 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 23, 2017
• Results First Posted: December 9, 2015

Record last verified: 2016-11

Locations

US (110); CA (2)