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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

291

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
      • 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

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
Intervention / Treatment
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

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

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

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

August 1, 2009

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 1, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

November 16, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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