Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)

NCT01044459 | Completed Phase 3 Results

• 1 other identifier: LAS-MD-35
• Study Type: interventional
• Target: 605
• Locations: 2 countries
• Sites: 113

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.

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 (1)

• Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)

  Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.

  From baseline to 52 weeks

Secondary Outcomes (1)

• Change From Baseline in Peak FEV1

  52 weeks

Study Arms (2)

Aclidinium Bromide 200 µg

EXPERIMENTAL

aclidinium bromide, inhaled, 52 weeks of treatment

Drug: Aclidinium Bromide 200 µg

Aclidinium Bromide 400 µg

EXPERIMENTAL

aclidinium bromide, inhaled, 52 weeks of treatment

Drug: Aclidinium Bromide 400 µg

Interventions

Aclidinium Bromide 200 µg DRUG

aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment

Aclidinium Bromide 200 µg

Aclidinium Bromide 400 µg DRUG

aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

Aclidinium Bromide 400 µg

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, 2010; 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 (113)

Forest Investigative Site 1162

Birmingham, Alabama, 35209, United States

Location

Forest Investigative Site 1127

Mobile, Alabama, 36608, United States

Location

Forest Investigative Site 1475

Scottsdale, Arizona, 85258, United States

Location

Forest Investigative Site 1338

Tempe, Arizona, 85282, United States

Location

Forest Investigative Site 1349

Tucson, Arizona, 85710, United States

Location

Forest Investigative Site 1483

Buena Park, California, 90620, United States

Location

Forest Investigative Site 1350

Foothill Ranch, California, 92610, United States

Location

Forest Investigative Site 1509

Fresno, California, 93720, United States

Location

Forest Investigative Site 2065

Fullerton, California, 92835, United States

Location

Forest Investigative Site 1502

Huntington Park, California, 90255, United States

Location

Forest Investigative Site 1088

Lakewood, California, 90712, United States

Location

Forest Investigative Site 1534

Long Beach, California, 90813, United States

Location

Forest Investigative Site 2209

Los Angeles, California, 90095, United States

Location

Forest Investigative Site 1122

Orange, California, 92868, United States

Location

Forest Investigative Site 1508

Palm Springs, California, 92262, United States

Location

Forest Investigative Site 2064

Riverside, California, 92506, United States

Location

Forest Investigative Site 1533

Sacramento, California, 95825, United States

Location

Forest Investigative Site 2009

San Diego, California, 92120, United States

Location

Forest Investigative Site 1439

San Diego, California, 92123, United States

Location

Forest Investigative Site 1503

San Diego, California, 92928, United States

Location

Forest Investigative Site 1347

San Jose, California, 95117, United States

Location

Forest Investigative Site 1344

Spring Valley, California, 91978, United States

Location

Forest Investigative Site 2039

Walnut Creek, California, 94598, 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 1104

Hartford, Connecticut, 06105, United States

Location

Forest Investigative Site 1482

Stamford, Connecticut, 06902-3633, United States

Location

Forest Investigative Site 1346

Newark, Delaware, 19713, United States

Location

Forest Investigative Site 1154

Brandon, Florida, 33511, United States

Location

Forest Investigative Site 1152

Clearwater, Florida, 33765, United States

Location

Forest Investigative Site 1514

Coral Gables, Florida, 33134, United States

Location

Forest Investigative Site 0670

DeLand, Florida, 32720, United States

Location

Forest Investigative Site 1516

Edgewater, Florida, 32141, United States

Location

Forest Investigative Site 0990

Fort Lauderdale, Florida, 33316, United States

Location

Forest Investigative Site 1513

Hialeah, Florida, 33102, United States

Location

Forest Investigative Site 1420

Miami, Florida, 33133, United States

Location

Forest Investigative Site 1432

Miami, Florida, 33143, United States

Location

Forest Investigative Site 1484

Miramar, Florida, 33025, United States

Location

Forest Investigative Site 1340

Ocala, Florida, 34471, United States

Location

Forest Investigative Site 1488

Pembroke Pines, Florida, 33027, United States

Location

Forest Investigative Site 0974

Pensacola, Florida, 32504, United States

Location

Forest Investigative Site 1397

Port Charlotte, Florida, 33952, United States

Location

Forest Investigative Site 1383

Port Orange, Florida, 32127, United States

Location

Forest Investigative Site 2082

Tamarac, Florida, 33321, United States

Location

Forest Investigative Site 2047

Tampa, Florida, 33613, United States

Location

Forest Investigative Site 1395

Valrico, Florida, 33596, United States

Location

Forest Investigative Site 0980

Atlanta, Georgia, 30342, United States

Location

Forest Investigative Site 1491

Atlanta, Georgia, 30342, United States

Location

Forest Investigative Site 0987

Austell, Georgia, 30106, United States

Location

Forest Investigative Site 1532

Columbus, Georgia, 31904, United States

Location

Forest Investigative Site 2051

River Forest, Illinois, 60305, United States

Location

Forest Investigative Site 0989

Skokie, Illinois, 60076, United States

Location

Forest Investigative Site 1436

Avon, Indiana, 46123, United States

Location

Forest Investigative Site 2085

Crescent Springs, Kentucky, 41017, United States

Location

Forest Investigative Site 1520

Crestview Hills, Kentucky, 41017, United States

Location

Forest Investigative Site 0539

Lexington, Kentucky, 40504, United States

Location

Forest Investigative Site 1336

Louisville, Kentucky, 40215, United States

Location

Forest Investigative Site 1478

Louisville, Kentucky, 40217, United States

Location

Forest Investigative Site 2024

Lafayette, Louisiana, 70503, United States

Location

Forest Investigative Site 1333

Baltimore, Maryland, 21236, United States

Location

Forest Investigative Site 1421

Fall River, Massachusetts, 02720, United States

Location

Forest Investigative Site 1342

Stevensville, Michigan, 49127, United States

Location

Forest Investigative Site 1438

Ypsilanti, Michigan, 48197, United States

Location

Forest Investigative Site 2041

Minneapolis, Minnesota, 55402, United States

Location

Forest Investigative Site 1351

Plymouth, Minnesota, 55441, United States

Location

Forest Investigative Site 1100

Florissant, Missouri, 63033, United States

Location

Forest Investigative Site 2079

Saint Charles, Missouri, 63301, United States

Location

Forest Investigative Site 1343

St Louis, Missouri, 63128, United States

Location

Forest Investigative Site 1329

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 1369

St Louis, Missouri, 63141, United States

Location

Forest Investigative Site 1335

St Louis, Missouri, 63143, United States

Location

Forest Investigative Site 1367

Papillion, Nebraska, 68046, United States

Location

Forest Investigative Site 1150

Berlin, New Jersey, 09009, United States

Location

Forest Investigative Site 1339

Cherry Hill, New Jersey, 08003, United States

Location

Forest Investigative Site 1515

Elizabeth, New Jersey, 07202, United States

Location

Forest Investigative Site 1394

Ocean City, New Jersey, 07712, United States

Location

Forest Investigative Site 2062

Bronxville, New York, 10708, United States

Location

Forest Investigative Site 1147

Brooklyn, New York, 11234, United States

Location

Forest Investigative Site 1151

New Hyde Park, New York, 11040, United States

Location

Forest Investigative Site 1114

New York, New York, 10010, United States

Location

Forest Investigative Site 1163

New York, New York, 10016, United States

Location

Forest Investigative Site 1481

Newburgh, New York, 12550, United States

Location

Forest Investigative Site 0479

Rochester, New York, 14618, United States

Location

Forest Investigative Site 1368

The Bronx, New York, 10457, United States

Location

Forest Investigative Site 2081

Charlotte, North Carolina, 28207, United States

Location

Forest Investigative Site 1334

Charlotte, North Carolina, 28226, United States

Location

Forest Investigative Site 1366

HighPoint, North Carolina, 27262, United States

Location

Forest Investigative Site 1382

Statesville, North Carolina, 28625, United States

Location

Forest Investigative Site 1134

Canton, Ohio, 44718, United States

Location

Forest Investigative Site 2007

Cincinnati, Ohio, 45231, United States

Location

Forest Investigative Site 1434

Cleveland, Ohio, 44122, United States

Location

Forest Investigative Site 1433

Columbus, Ohio, 43213, United States

Location

Forest Investigative Site 0959

Columbus, Ohio, 43214, United States

Location

Forest Investigative Site 1505

Columbus, Ohio, 43235, United States

Location

Forest Investigative Site 1435

Dayton, Ohio, 45406, United States

Location

Forest Investigative Site 1348

Bend, Oregon, 97701, United States

Location

Forest Investigative Site 1504

Hershey, Pennsylvania, 17033, United States

Location

Forest Investigative Site 2072

Charleston, South Carolina, 29406, United States

Location

Forest Investigative Site 0900

Spartanburg, South Carolina, 29303, United States

Location

Forest Investigative Site 1365

Rapid City, South Dakota, 57702, United States

Location

Forest Investigative Site 0962

Nashville, Tennessee, 37232, 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 1337

Houston, Texas, 77054, United States

Location

Forest Investigative Site 1396

San Antonio, Texas, 78125, United States

Location

Forest Investigative Site 1384

San Antonio, Texas, 78328, United States

Location

Forest Investigative Site 1330

South Burlington, Vermont, 05403, United States

Location

Forest Investigative Site 1120

Bellingham, Washington, 98225, United States

Location

Forest Investigative Site 1531

Tacoma, Washington, 98405, United States

Location

Forest Investigative Site 2201

Kelowna, British Columbia, V1Y 8E7, Canada

Location

Forest Investigative Site 1157

Toronto, Ontario, M3H 5S4, Canada

Location

Forest Investigative Site 1168

Toronto, Ontario, M5G 1N8, Canada

Location

Related Links

• las-md-35-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

Limitations and Caveats

Site 1420 randomized 31 patients who were discontinued by 21 Jan 2011 due to significant deviations documented in a letter to the FDA on 07 Jan 2011. No changes to the analyses were prospectively specified in the amended statistical analysis plan.

Results Point of Contact

• Title: AstraZeneca Clinical
• Organization: Study Information Center

information.center@astrazeneca.com

1-877-240-9479

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: January 5, 2010
• First Posted: January 7, 2010
• Study Start: November 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: April 20, 2017
• Results First Posted: September 13, 2012

Record last verified: 2017-02

Locations

US (110); CA (3)