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

March 9, 2017 updated by: AstraZeneca

A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

605

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 8E7
        • Forest Investigative Site 2201
    • Ontario
      • Toronto, Ontario, Canada, M3H 5S4
        • Forest Investigative Site 1157
      • Toronto, Ontario, Canada, M5G 1N8
        • Forest Investigative Site 1168
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Forest Investigative Site 1162
      • Mobile, Alabama, United States, 36608
        • Forest Investigative Site 1127
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Forest Investigative Site 1475
      • Tempe, Arizona, United States, 85282
        • Forest Investigative Site 1338
      • Tucson, Arizona, United States, 85710
        • Forest Investigative Site 1349
    • California
      • Buena Park, California, United States, 90620
        • Forest Investigative Site 1483
      • Foothill Ranch, California, United States, 92610
        • Forest Investigative Site 1350
      • Fresno, California, United States, 93720
        • Forest Investigative Site 1509
      • Fullerton, California, United States, 92835
        • Forest Investigative Site 2065
      • Huntington Park, California, United States, 90255
        • Forest Investigative Site 1502
      • Lakewood, California, United States, 90712
        • Forest Investigative Site 1088
      • Long Beach, California, United States, 90813
        • Forest Investigative Site 1534
      • Los Angeles, California, United States, 90095
        • Forest Investigative Site 2209
      • Orange, California, United States, 92868
        • Forest Investigative Site 1122
      • Palm Springs, California, United States, 92262
        • Forest Investigative Site 1508
      • Riverside, California, United States, 92506
        • Forest Investigative Site 2064
      • Sacramento, California, United States, 95825
        • Forest Investigative Site 1533
      • San Diego, California, United States, 92120
        • Forest Investigative Site 2009
      • San Diego, California, United States, 92123
        • Forest Investigative Site 1439
      • San Diego, California, United States, 92928
        • Forest Investigative Site 1503
      • San Jose, California, United States, 95117
        • Forest Investigative Site 1347
      • Spring Valley, California, United States, 91978
        • Forest Investigative Site 1344
      • Walnut Creek, California, United States, 94598
        • Forest Investigative Site 2039
    • Colorado
      • Fort Collins, Colorado, United States, 80528
        • Forest Investigative Site 2037
      • Wheat Ridge, Colorado, United States, 80033
        • Forest Investigative Site 1327
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Forest Investigative Site 1104
      • Stamford, Connecticut, United States, 06902-3633
        • Forest Investigative Site 1482
    • Delaware
      • Newark, Delaware, United States, 19713
        • Forest Investigative Site 1346
    • Florida
      • Brandon, Florida, United States, 33511
        • Forest Investigative Site 1154
      • Clearwater, Florida, United States, 33765
        • Forest Investigative Site 1152
      • Coral Gables, Florida, United States, 33134
        • Forest Investigative Site 1514
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site 0670
      • Edgewater, Florida, United States, 32141
        • Forest Investigative Site 1516
      • Fort Lauderdale, Florida, United States, 33316
        • Forest Investigative Site 0990
      • Hialeah, Florida, United States, 33102
        • Forest Investigative Site 1513
      • Miami, Florida, United States, 33143
        • Forest Investigative Site 1432
      • Miami, Florida, United States, 33133
        • Forest Investigative Site 1420
      • Miramar, Florida, United States, 33025
        • Forest Investigative Site 1484
      • Ocala, Florida, United States, 34471
        • Forest Investigative Site 1340
      • Pembroke Pines, Florida, United States, 33027
        • Forest Investigative Site 1488
      • Pensacola, Florida, United States, 32504
        • Forest Investigative Site 0974
      • Port Charlotte, Florida, United States, 33952
        • Forest Investigative Site 1397
      • Port Orange, Florida, United States, 32127
        • Forest Investigative Site 1383
      • Tamarac, Florida, United States, 33321
        • Forest Investigative Site 2082
      • Tampa, Florida, United States, 33613
        • Forest Investigative Site 2047
      • Valrico, Florida, United States, 33596
        • Forest Investigative Site 1395
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site 0980
      • Atlanta, Georgia, United States, 30342
        • Forest Investigative Site 1491
      • Austell, Georgia, United States, 30106
        • Forest Investigative Site 0987
      • Columbus, Georgia, United States, 31904
        • Forest Investigative Site 1532
    • Illinois
      • River Forest, Illinois, United States, 60305
        • Forest Investigative Site 2051
      • Skokie, Illinois, United States, 60076
        • Forest Investigative Site 0989
    • Indiana
      • Avon, Indiana, United States, 46123
        • Forest Investigative Site 1436
    • Kentucky
      • Crescent Springs, Kentucky, United States, 41017
        • Forest Investigative Site 2085
      • Crestview Hills, Kentucky, United States, 41017
        • Forest Investigative Site 1520
      • Lexington, Kentucky, United States, 40504
        • Forest Investigative Site 0539
      • Louisville, Kentucky, United States, 40217
        • Forest Investigative Site 1478
      • Louisville, Kentucky, United States, 40215
        • Forest Investigative Site 1336
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Forest Investigative Site 2024
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Forest Investigative Site 1333
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Forest Investigative Site 1421
    • Michigan
      • Stevensville, Michigan, United States, 49127
        • Forest Investigative Site 1342
      • Ypsilanti, Michigan, United States, 48197
        • Forest Investigative Site 1438
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Forest Investigative Site 2041
      • Plymouth, Minnesota, United States, 55441
        • Forest Investigative Site 1351
    • Missouri
      • Florissant, Missouri, United States, 63033
        • Forest Investigative Site 1100
      • St. Charles, Missouri, United States, 63301
        • Forest Investigative Site 2079
      • St. Louis, Missouri, United States, 63128
        • Forest Investigative Site 1343
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site 1329
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site 1369
      • St. Louis, Missouri, United States, 63143
        • Forest Investigative Site 1335
    • Nebraska
      • Papillion, Nebraska, United States, 68046
        • Forest Investigative Site 1367
    • New Jersey
      • Berlin, New Jersey, United States, 09009
        • Forest Investigative Site 1150
      • Cherry Hill, New Jersey, United States, 08003
        • Forest Investigative Site 1339
      • Elizabeth, New Jersey, United States, 07202
        • Forest Investigative Site 1515
      • Ocean, New Jersey, United States, 07712
        • Forest Investigative Site 1394
    • New York
      • Bronx, New York, United States, 10457
        • Forest Investigative Site 1368
      • Bronxville, New York, United States, 10708
        • Forest Investigative Site 2062
      • Brooklyn, New York, United States, 11234
        • Forest Investigative Site 1147
      • New Hyde Park, New York, United States, 11040
        • Forest Investigative Site 1151
      • New York, New York, United States, 10010
        • Forest Investigative Site 1114
      • New York, New York, United States, 10016
        • Forest Investigative Site 1163
      • Newburgh, New York, United States, 12550
        • Forest Investigative Site 1481
      • Rochester, New York, United States, 14618
        • Forest Investigative Site 0479
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Forest Investigative Site 2081
      • Charlotte, North Carolina, United States, 28226
        • Forest Investigative Site 1334
      • HighPoint, North Carolina, United States, 27262
        • Forest Investigative Site 1366
      • Statesville, North Carolina, United States, 28625
        • Forest Investigative Site 1382
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 1134
      • Cincinnati, Ohio, United States, 45231
        • Forest Investigative Site 2007
      • Cleveland, Ohio, United States, 44122
        • Forest Investigative Site 1434
      • Columbus, Ohio, United States, 43213
        • Forest Investigative Site 1433
      • Columbus, Ohio, United States, 43214
        • Forest Investigative Site 0959
      • Columbus, Ohio, United States, 43235
        • Forest Investigative Site 1505
      • Dayton, Ohio, United States, 45406
        • Forest Investigative Site 1435
    • Oregon
      • Bend, Oregon, United States, 97701
        • Forest Investigative Site 1348
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Forest Investigative Site 1504
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Forest Investigative Site 2072
      • Spartanburg, South Carolina, United States, 29303
        • Forest Investigative Site 0900
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Forest Investigative Site 1365
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Forest Investigative Site 0962
    • Texas
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1155
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1328
      • El Paso, Texas, United States, 79903
        • Forest Investigative Site 1332
      • Houston, Texas, United States, 77054
        • Forest Investigative Site 1337
      • San Antonio, Texas, United States, 78125
        • Forest Investigative Site 1396
      • San Antonio, Texas, United States, 78328
        • Forest Investigative Site 1384
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Forest Investigative Site 1330
    • Washington
      • Bellingham, Washington, United States, 98225
        • Forest Investigative Site 1120
      • Tacoma, Washington, United States, 98405
        • Forest Investigative Site 1531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aclidinium Bromide 200 µg
aclidinium bromide, inhaled, 52 weeks of treatment
Drug: Aclidinium Bromide 200 µg
aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Experimental: Aclidinium Bromide 400 µg
aclidinium bromide, inhaled, 52 weeks of treatment
Drug: Aclidinium Bromide 400 µg
aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Time Frame: From baseline to 52 weeks
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
From baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Peak FEV1
Time Frame: 52 weeks
Change From Baseline in Peak FEV1 in liters at Week 52.
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 6, 2010

First Posted (Estimate)

January 7, 2010

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAS-MD-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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