Long-term Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-36)

November 16, 2016 updated by: AstraZeneca

A Long-term, Randomized, Double-blind Extension Study of the Safety, Tolerability, and Efficacy of Aclidinium Bromide at Two Dose Levels When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

The purpose of this extension study is to evaluate the long-term safety, tolerability, and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe chronic obstructive pulmonary disease (COPD). This study will be 54 weeks in duration; a 52-week double-blind treatment period and 2 week follow-up phone call, following a 12 week lead-in study. All patients will be randomized from the lead-in study at one of two doses of aclidinium.

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.
291

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
      • Vancouver, British Columbia, Canada, V5Z 4E1
        • Forest Investigative Site 1177
    • Ontario
      • Niagara Falls, Ontario, Canada, L2g 1J4
        • Forest Investigative Site 2200
      • Toronto, Ontario, Canada, M5T 3A9
        • Forest Investigative Site 1171
      • Toronto, Ontario, Canada, M6H 3M2
        • Forest Investigative Site 2203
      • 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
      • Glendale, Arizona, United States, 85306
        • Forest Investigative Site 0909
      • Phoenix, Arizona, United States, 85023
        • Forest Investigative Site 2060
    • California
      • Fullerton, California, United States, 92835
        • Forest Investigative Site 2065
      • Lakewood, California, United States, 90712
        • Forest Investigative Site 1088
      • Orange, California, United States, 92868
        • Forest Investigative Site 1122
      • Rancho Mirage, California, United States, 92270
        • Forest Investigative Site 2029
      • Riverside, California, United States, 92506
        • Forets Investigative Site 2064
      • Sacramento, California, United States, 95821
        • Forest Investigative Site 0517
      • San Diego, California, United States, 92120
        • Forest Investigative Site 2009
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Forest Investigative Site 1137
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Forest Investigative Site 2100
    • Florida
      • Brandon, Florida, United States, 33511
        • Forest Investigative Site 1154
      • Clearwater, Florida, United States, 33765
        • Forest Investigative Site 1152
      • DeLand, Florida, United States, 32720
        • Forest Investigative Site 0670
      • Fort Lauderdale, Florida, United States, 33316
        • Forest Investigative Site 0990
      • Melbourne, Florida, United States, 32935
        • Forest Investigative Site 1167
      • Ormond Beach, Florida, United States, 32174
        • Forest Investigative Site 1060
      • Pensacola, Florida, United States, 32504
        • Forest Investigative Site 0974
      • Tamarac, Florida, United States, 33321
        • Forest Investigative Site 2082
      • Tampa, Florida, United States, 33613
        • Forest Investigative Site 2047
      • Tampa, Florida, United States, 33606
        • Forest Investigative Site 2053
      • Winter Park, Florida, United States, 32789
        • Forest Investigative Site 1185
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Forest Investigative Site 1183
      • Austell, Georgia, United States, 30106
        • Forest Investigative Site 0987
      • Blue Ridge, Georgia, United States, 30513
        • Forest Investigative Site 1101
      • Decatur, Georgia, United States, 30033
        • Forest Investigative Site 1180
      • Duluth, Georgia, United States, 30096
        • Forest Investigative Site 1161
    • Illinois
      • River Forest, Illinois, United States, 60305
        • Forest Investigative Site 2051
      • Skokie, Illinois, United States, 60076
        • Forest Investigative Site 0989
    • Indiana
      • South Bend, Indiana, United States, 46617
        • Forest Investigative Site 1149
    • Kentucky
      • Crescent Springs, Kentucky, United States, 41017
        • Forest Investigative Site 2085
      • Lexington, Kentucky, United States, 40504
        • Forest Investigative Site 0539
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Forest Investigative Site 2024
    • Maine
      • Biddeford, Maine, United States, 04005
        • Forest Investigative Site 2040
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Forest Investigative Site 1128
      • Minneapolis, Minnesota, United States, 55402
        • Forest Investigative Site 2041
      • Minneapolis, Minnesota, United States, 55407
        • Forest Investigative Site 1124
    • Missouri
      • Florissant, Missouri, United States, 63033
        • Forest Investigative Site 1100
      • St. Charles, Missouri, United States, 63301
        • Forest Investigative Site 2079
    • Montana
      • Butte, Montana, United States, 59701
        • Forest Investigative Site 2067
    • Nebraska
      • Papillion, Nebraska, United States, 68406
        • Forest Investigative Site 1169
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Forest Investigative Site 1150
      • Summit, New Jersey, United States, 07901
        • Forest Investigative Site 2084
    • New York
      • Brooklyn, New York, United States, 11234
        • Forest Investigative Site 1147
      • Elmira, New York, United States, 14901
        • Forest Investigative Site 1119
      • New Hyde Park, New York, United States, 11040
        • Forest Investigative Site 1151
      • New York, New York, United States, 10016
        • Forest Investigative Site 1163
      • New York, New York, United States, 10016
        • Forest Investigative Site 1141
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Forest Investigative Site 1130
    • Ohio
      • Canton, Ohio, United States, 44718
        • Forest Investigative Site 1134
      • Centerville, Ohio, United States, 45459
        • Forest Investigative Site 1181
      • Cincinnati, Ohio, United States, 45242
        • Forest Investigative Site 2028
      • Cincinnati, Ohio, United States, 45231
        • Forest Investigative Site 2007
      • Cincinnati, Ohio, United States, 45227
        • Forest Investigative Site 1136
      • Columbus, Ohio, United States, 43215
        • Forest Investigative Site 0959
      • Columbus, Ohio, United States, 43215
        • Forest Investigative Site 2006
    • Oregon
      • Medford, Oregon, United States, 97504
        • Forest Investigative Site 2043
      • Portland, Oregon, United States, 97213
        • Forest Investigative Site 1106
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18020
        • Forest Investigative Site 1126
      • Erie, Pennsylvania, United States, 16506
        • Forest Investigative Site 2016
      • Pittsburgh, Pennsylvania, United States, 15243
        • Forest Investigative Site 1146
      • Upland, Pennsylvania, United States, 19013
        • Forest Investigative Site 1158
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Forest Investigative Site 1089
      • Johnston, Rhode Island, United States, 02919
        • Forest Investigative Site 1144
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Forest Investigative Site 2072
      • Greenville, South Carolina, United States, 29615
        • Forest Investigative Site 1078
      • Greer, South Carolina, United States, 29651
        • Forest Investigative Site 2080
      • Spartanburg, South Carolina, United States, 29303
        • Forest Investigative Site 1121
    • Texas
      • Dallas, Texas, United States, 75231
        • Forest Investigative Site 1155
      • Fort Worth, Texas, United States, 76104
        • Forest Investigative Site 2012
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 1165
      • Waco, Texas, United States, 76712
        • Forest Investigative Site 1129
    • Virginia
      • Richmond, Virginia, United States, 23225
        • Forest Investigative Site 2099
    • Washington
      • Spokane, Washington, United States, 99204
        • Forest Investigative Site 1142
      • 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:

  • Completion of a lead-in study (NCT00891462)

Exclusion Criteria:

  • Use or anticipated use of any medication prohibited in this study
  • Evidence of abnormal clinical laboratory values, vital signs, or electrocardiographic (ECG) results or the presence of abnormities in physical examination findings
  • The presence of anti-cholinergic effects (eg, dry mouth, urinary retention, narrow angle glaucoma)
  • QTcB of >500 msec on both the pre-dose and post-dose ECG
  • Women who are pregnant, intend to become pregnant, or are breast-feeding
  • A life expectancy of less than 1 year
  • Noncompliance with IP dosing and/or attending clinic visits during the lead-in study
  • Significant interruption of double-blind therapy during the transition from the lead-in study into the extension study.

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 dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
Experimental: 2
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
Drug: Aclidinium bromide
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: Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks
Change From Baseline (Visit 2 of lead-in Study NCT00891462, [LAS-MD-33]) to Week 52 (Week 64 From Start of NCT00891462, [LAS-MD-33]) in Morning Predose (Trough) FEV1
Change from baseline (visit 2 of lead-in study LAS-MD-33) 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 (Visit 2 of study NCT00891462, [LAS-MD-33])in Peak FEV1 in liters at Week 52 (Week 64 from the start of NCT00891462, [LAS-MD-33]).
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.

General Publications

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.
August 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.
October 1, 2010

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.
October 1, 2010

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).
September 1, 2009

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.
September 1, 2009

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.
September 2, 2009

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 6, 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 16, 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-36

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings