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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)

This study has been completed.
Sponsor:
Collaborator:
Almirall, S.A.
Information provided by (Responsible Party):
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00970268
First received: September 1, 2009
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Aclidinium bromide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change From Baseline in Peak FEV1 [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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]).


Enrollment: 291
Study Start Date: January 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: 2
Aclidinium bromide dose, inhaled, for 52 weeks of treatment
Drug: Aclidinium bromide
Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970268

  Hide Study Locations
Locations
United States, Alabama
Forest Investigative Site 1162
Birmingham, Alabama, United States, 35209
Forest Investigative Site 1127
Mobile, Alabama, United States, 36608
United States, Arizona
Forest Investigative Site 0909
Glendale, Arizona, United States, 85306
Forest Investigative Site 2060
Phoenix, Arizona, United States, 85023
United States, California
Forest Investigative Site 2065
Fullerton, California, United States, 92835
Forest Investigative Site 1088
Lakewood, California, United States, 90712
Forest Investigative Site 1122
Orange, California, United States, 92868
Forest Investigative Site 2029
Rancho Mirage, California, United States, 92270
Forets Investigative Site 2064
Riverside, California, United States, 92506
Forest Investigative Site 0517
Sacramento, California, United States, 95821
Forest Investigative Site 2009
San Diego, California, United States, 92120
United States, Colorado
Forest Investigative Site 1137
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Forest Investigative Site 2100
Waterbury, Connecticut, United States, 06708
United States, Florida
Forest Investigative Site 1154
Brandon, Florida, United States, 33511
Forest Investigative Site 1152
Clearwater, Florida, United States, 33765
Forest Investigative Site 0670
DeLand, Florida, United States, 32720
Forest Investigative Site 0990
Fort Lauderdale, Florida, United States, 33316
Forest Investigative Site 1167
Melbourne, Florida, United States, 32935
Forest Investigative Site 1060
Ormond Beach, Florida, United States, 32174
Forest Investigative Site 0974
Pensacola, Florida, United States, 32504
Forest Investigative Site 2082
Tamarac, Florida, United States, 33321
Forest Investigative Site 2047
Tampa, Florida, United States, 33613
Forest Investigative Site 2053
Tampa, Florida, United States, 33606
Forest Investigative Site 1185
Winter Park, Florida, United States, 32789
United States, Georgia
Forest Investigative Site 1183
Atlanta, Georgia, United States, 30329
Forest Investigative Site 0987
Austell, Georgia, United States, 30106
Forest Investigative Site 1101
Blue Ridge, Georgia, United States, 30513
Forest Investigative Site 1180
Decatur, Georgia, United States, 30033
Forest Investigative Site 1161
Duluth, Georgia, United States, 30096
United States, Illinois
Forest Investigative Site 2051
River Forest, Illinois, United States, 60305
Forest Investigative Site 0989
Skokie, Illinois, United States, 60076
United States, Indiana
Forest Investigative Site 1149
South Bend, Indiana, United States, 46617
United States, Kentucky
Forest Investigative Site 2085
Crescent Springs, Kentucky, United States, 41017
Forest Investigative Site 0539
Lexington, Kentucky, United States, 40504
United States, Louisiana
Forest Investigative Site 2024
Lafayette, Louisiana, United States, 70503
United States, Maine
Forest Investigative Site 2040
Biddeford, Maine, United States, 04005
United States, Minnesota
Forest Investigative Site 1128
Edina, Minnesota, United States, 55435
Forest Investigative Site 1124
Minneapolis, Minnesota, United States, 55407
Forest Investigative Site 2041
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Forest Investigative Site 1100
Florissant, Missouri, United States, 63033
Forest Investigative Site 2079
St. Charles, Missouri, United States, 63301
United States, Montana
Forest Investigative Site 2067
Butte, Montana, United States, 59701
United States, Nebraska
Forest Investigative Site 1169
Papillion, Nebraska, United States, 68406
United States, New Jersey
Forest Investigative Site 1150
Berlin, New Jersey, United States, 08009
Forest Investigative Site 2084
Summit, New Jersey, United States, 07901
United States, New York
Forest Investigative Site 1147
Brooklyn, New York, United States, 11234
Forest Investigative Site 1119
Elmira, New York, United States, 14901
Forest Investigative Site 1151
New Hyde Park, New York, United States, 11040
Forest Investigative Site 1141
New York, New York, United States, 10016
Forest Investigative Site 1163
New York, New York, United States, 10016
United States, North Carolina
Forest Investigative Site 1130
Asheville, North Carolina, United States, 28801
United States, Ohio
Forest Investigative Site 1134
Canton, Ohio, United States, 44718
Forest Investigative Site 1181
Centerville, Ohio, United States, 45459
Forest Investigative Site 1136
Cincinnati, Ohio, United States, 45227
Forest Investigative Site 2007
Cincinnati, Ohio, United States, 45231
Forest Investigative Site 2028
Cincinnati, Ohio, United States, 45242
Forest Investigative Site 0959
Columbus, Ohio, United States, 43215
Forest Investigative Site 2006
Columbus, Ohio, United States, 43215
United States, Oregon
Forest Investigative Site 2043
Medford, Oregon, United States, 97504
Forest Investigative Site 1106
Portland, Oregon, United States, 97213
United States, Pennsylvania
Forest Investigative Site 1126
Bethlehem, Pennsylvania, United States, 18020
Forest Investigative Site 2016
Erie, Pennsylvania, United States, 16506
Forest Investigative Site 1146
Pittsburgh, Pennsylvania, United States, 15243
Forest Investigative Site 1158
Upland, Pennsylvania, United States, 19013
United States, Rhode Island
Forest Investigative Site 1089
East Providence, Rhode Island, United States, 02914
Forest Investigative Site 1144
Johnston, Rhode Island, United States, 02919
United States, South Carolina
Forest Investigative Site 2072
Charleston, South Carolina, United States, 29406
Forest Investigative Site 1078
Greenville, South Carolina, United States, 29615
Forest Investigative Site 2080
Greer, South Carolina, United States, 29651
Forest Investigative Site 1121
Spartanburg, South Carolina, United States, 29303
United States, Texas
Forest Investigative Site 1155
Dallas, Texas, United States, 75231
Forest Investigative Site 2012
Fort Worth, Texas, United States, 76104
Forest Investigative Site 1165
San Antonio, Texas, United States, 78229
Forest Investigative Site 1129
Waco, Texas, United States, 76712
United States, Virginia
Forest Investigative Site 2099
Richmond, Virginia, United States, 23225
United States, Washington
Forest Investigative Site 1142
Spokane, Washington, United States, 99204
Forest Investigative Site 0988
Tacoma, Washington, United States, 98405
Canada, British Columbia
Forest Investigative Site 2201
Kelowna, British Columbia, Canada, V1Y 8E7
Forest Investigative Site 1177
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Ontario
Forest Investigative Site 2200
Niagara Falls, Ontario, Canada, L2g 1J4
Forest Investigative Site 1168
Toronto, Ontario, Canada, M5G 1N8
Forest Investigative Site 1171
Toronto, Ontario, Canada, M5T 3A9
Forest Investigative Site 2203
Toronto, Ontario, Canada, M6H 3M2
Sponsors and Collaborators
Forest Laboratories
Almirall, S.A.
Investigators
Study Director: Jordan Lateiner, MS Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
  More Information

No publications provided

Responsible Party: Forest Laboratories
ClinicalTrials.gov Identifier: NCT00970268     History of Changes
Other Study ID Numbers: LAS-MD-36
Study First Received: September 1, 2009
Results First Received: August 14, 2012
Last Updated: August 14, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Forest Laboratories:
COPD
Chronic Obstructive Pulmonary Disease
Chronic Bronchitis
Emphysema
Airflow Obstruction, Chronic
Chronic Airflow Obstruction
Chronic Obstructive Airway Disease
Chronic Obstructive Lung Disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bromides
Anticonvulsants
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014