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

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.
605

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
      • 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

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, 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

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: 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

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
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

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
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

Sponsor

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

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.
November 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.
April 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.
April 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 5, 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 6, 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 7, 2010

Study Record Updates

Last Update Posted (Actual)

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.
April 20, 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.
March 9, 2017

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.
February 1, 2017

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-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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