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

November 30, 2016 updated by: AstraZeneca

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Tolerability of 2 Doses of Aclidinium Bromide Compared With Placebo for 12 Weeks in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease Followed by a 40-Week Evaluation of the Higher Aclidinium Bromide Dose

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
544

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Forest Investigative Site 1177
    • Ontario
      • Windsor, Ontario, Canada, N8X 5A6
        • Forest Investigative Site 0969
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Forest Investigative Site 1493
      • Birmingham, Alabama, United States, 35233
        • Forest Investigative Site 1419
      • Muscle Shoals, Alabama, United States, 35662
        • Forest Investigative Site 1413
      • Pell City, Alabama, United States, 35128
        • Forest Investigative Site 1353
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Forest Investigative Site 1379
    • California
      • Fullerton, California, United States, 92835
        • Forest Investigative Site 2065
      • National City, California, United States, 91950
        • Forest Investigative Site 1451
      • Paramount, California, United States, 90723
        • Forest Investigative Site 1388
      • Rolling Hill Estates, California, United States, 90274
        • Forest Investigative Site 1424
      • Sacramento, California, United States, 95817
        • Forest Investigative Site 1427
      • San Diego, California, United States, 92120
        • Forest Investigative Site 2009
      • San Diego, California, United States, 92120
        • Forest Investigative Site 1418
      • Torrance, California, United States, 90505
        • Forest Investigative Site 1374
      • Vista, California, United States, 92083
        • Forest Investigative Site 1331
    • Colorado
      • Golden, Colorado, United States, 80401
        • Forest Investigative Site 1380
      • Pueblo, Colorado, United States, 81001
        • Forest Investigative Site 1447
    • Florida
      • Clearwater, Florida, United States, 33756
        • Forest Investigative Site 1364
      • Edgewater, Florida, United States, 32132
        • Forest Investigative Site 1516
      • Hollywood, Florida, United States, 33021
        • Forest Investigative Site 1403
      • Homestead, Florida, United States, 33032
        • Forest Investigative Site 1485
      • Miami, Florida, United States, 33126
        • Forest Investigative Site 1352
      • Naples, Florida, United States, 34110
        • Forest Investigative Site 1391
      • Port Orange, Florida, United States, 32129
        • Forest Investigative Site 1376
      • South Miami, Florida, United States, 33143
        • Forest Investigative Site 1372
      • Trinity, Florida, United States, 34655
        • Forest Investigative Site 1407
      • Winter Park, Florida, United States, 32789
        • Forest Investigative Site 1185
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Forest Investigative Site 1386
      • Calhoun, Georgia, United States, 30701
        • Forest Investigative Site 1411
      • Lawrenceville, Georgia, United States, 30046
        • Forest Investigative Site 1528
    • Idaho
      • Coeur d' Alene, Idaho, United States, 83814
        • Forest Investigative Site 0679
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Forest Investigative Site 1385
      • O'Fallon, Illinois, United States, 62269
        • Forest Investigative Site 1409
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Forest Investigative Site 1479
      • Evansville, Indiana, United States, 47714
        • Forest Investigative Site 2022
      • Indianapolis, Indiana, United States, 46256
        • Forest Investigative Site 1441
      • South Bend, Indiana, United States, 46617
        • Forest Investigative Site 1149
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Forest Investigative Site 1406
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Forest Investigative Site 1080
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Forest Investigative Site 2033
      • Hazard, Kentucky, United States, 41701
        • Forest Investigative Site 1090
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Forest Investigative Site 1430
      • New Orleans, Louisiana, United States, 70119
        • Forest Investigative Site 1446
      • Sunset, Louisiana, United States, 70584
        • Forest Investigative Site 1360
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Forest Investigative Site 1412
      • North East, Maryland, United States, 21901
        • Forest Investigative Site 1518
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Forest Investigative Site 1442
      • Fall River, Massachusetts, United States, 02720
        • Forest Investigative Site 1421
      • North Dartmouth, Massachusetts, United States, 02747
        • Forest Investigative Site 1029
    • Michigan
      • Chelsea, Michigan, United States, 48118
        • Forest Investigative Site 1405
      • Livonia, Michigan, United States, 48152
        • Forest Investigative Site 0889
      • Troy, Michigan, United States, 48085
        • Forest Investigative Site 1487
    • Minnesota
      • Edina, Minnesota, United States, 58435
        • Forest Investigative Site 1128
      • Fridley, Minnesota, United States, 55432
        • Forest Investigative Site 1527
      • Minneapolis, Minnesota, United States, 55403
        • Forest Investigative Site 1124
      • Rochester, Minnesota, United States, 55904
        • Forest Investigative Site 1118
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Forest Investigative Site 1399
    • Montana
      • Missoula, Montana, United States, 59808
        • Forest Investigative Site 1400
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
        • Forest Investigative Site 1354
      • Bellevue, Nebraska, United States, 68123
        • Forest Investigative Site 1367
      • Fremont, Nebraska, United States, 68025
        • Forest Investigative Site 1476
      • Omaha, Nebraska, United States, 68114
        • Forest Investigative Site 1363
      • Omaha, Nebraska, United States, 68130
        • Forest Investigative Site 1390
      • Omaha, Nebraska, United States, 68134
        • Forest Investigative Site 1422
    • Nevada
      • Henderson, Nevada, United States, 89014
        • Forest Investigative Site 1359
      • Las Vegas, Nevada, United States, 89123
        • Forest Investigative Site 1355
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Forest Investigative Site 1486
    • New York
      • Larchmont, New York, United States, 10538
        • Forest Investigative Site 1489
      • New York, New York, United States, 10028
        • Forest Investigative Site 1425
      • North Syracuse, New York, United States, 13212
        • Forest Investigative Site 1373
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
        • Forest Investigative Site 1392
      • High Point, North Carolina, United States, 27262
        • Forest Investigative Site 1366
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Forest Investigative Site 1136
      • Cincinnati, Ohio, United States, 45245
        • Forest Investigative Site 1371
      • Columbus, Ohio, United States, 43213
        • Forest Investigative Site 1433
      • Columbus, Ohio, United States, 43209
        • Forest Investigative Site 1361
      • Toledo, Ohio, United States, 43608
        • Forest Investigative Site 1530
      • Zanesville, Ohio, United States, 43701
        • Forest Investigative Site 1393
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Forest Investigative Site 1362
    • Oregon
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site 2043
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site 2018
    • Pennsylvania
      • Collegeville, Pennsylvania, United States, 19426
        • Forest Investigative Site 1377
      • Erie, Pennsylvania, United States, 16508
        • Forest Investigative Site 1423
      • Feasterville, Pennsylvania, United States, 19053
        • Forest Investigative Site 1428
      • Philadelphia, Pennsylvania, United States, 19107
        • Forest Investigative Site 1443
      • Pittsburgh, Pennsylvania, United States, 15221
        • Forest Investigative Site 1510
      • Tipton, Pennsylvania, United States, 16684
        • Forest Investigative Site 1449
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Forest Investigative Site 1445
      • Lincoln, Rhode Island, United States, 02865
        • Forest Investigative Site 1477
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • Forest Investigative Site 1144
      • Easley, South Carolina, United States, 29640
        • Forest Investigative Site 1517
      • Grenville, South Carolina, United States, 29615
        • Forest Investigative Site 1506
      • Union, South Carolina, United States, 29379
        • Forest Investigative Site 1450
    • Tennessee
      • Fayetteville, Tennessee, United States, 37337
        • Forest Investigative Site 1526
      • Knoxville, Tennessee, United States, 37909
        • Forest Investigative Site 1356
      • Knoxville, Tennessee, United States, 37920
        • Forest Investigative Site 1417
    • Texas
      • Amarillo, Texas, United States, 79106
        • Forest Investigative Site 1389
      • Arlington, Texas, United States, 76012
        • Forest Investigative Site 1440
      • Austin, Texas, United States, 78756
        • Forest Investigative Site 1494
      • Houston, Texas, United States, 77074
        • Forest Investigative Site 1375
      • Houston, Texas, United States, 77079
        • Forest Investigative Site 1444
      • Houston, Texas, United States, 77083
        • Forest Investigative Site 1401
      • Houston, Texas, United States, 77479
        • Forest Investigative Site 1381
      • Hurst, Texas, United States, 76054
        • Forest Investigative Site 1357
      • Plano, Texas, United States, 75093
        • Forest Investigative Site 1426
      • Tomball, Texas, United States, 77375
        • Forest Investigative Site 1410
    • Virginia
      • Abingdon, Virginia, United States, 24210
        • Forest Investigative Site 1480
      • Lynchburg, Virginia, United States, 24501
        • Forest Investigative Site 1402
      • Norfolk, Virginia, United States, 23502
        • Forest Investigative Site 1404
      • Richmond, Virginia, United States, 23294
        • Forest Investigative Site 1358
    • Washington
      • Tacoma, Washington, United States, 98405
        • Forest Investigative Site 0988

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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, 2008; 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
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
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.
Experimental: 2
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
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.
Placebo Comparator: 3
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Morning Predose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Change from baseline (Week 0) to Week 12
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
Time Frame: Change from baseline (Week 0) to 52 Weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Peak Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: Change from baseline (Week 0) to Week 12
Change from baseline in peak FEV1 at week 12, Last Observation Carried Forward (LOCF)
Change from baseline (Week 0) to Week 12
Part B: Peak FEV1
Time Frame: Change from baseline (Week 0) to 52 Weeks
Change from Baseline in Peak FEV1 (L) at Week 52, Last Observation Carried Forward (LOCF)
Change from baseline (Week 0) to 52 Weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Esther Garcia, Ph. D., 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LAS-MD-38

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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