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:
Forest Laboratories
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
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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:
MedlinePlus related topics:
COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for:
Aclidinium bromide
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00970268
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| 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 2053 | |
| Tampa, Florida, United States, 33606 | |
| Forest Investigative Site 2047 | |
| Tampa, Florida, United States, 33613 | |
| 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 2041 | |
| Minneapolis, Minnesota, United States, 55402 | |
| Forest Investigative Site 1124 | |
| Minneapolis, Minnesota, United States, 55407 | |
| 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 2007 | |
| Cincinnati, Ohio, United States, 45231 | |
| Forest Investigative Site 2028 | |
| Cincinnati, Ohio, United States, 45242 | |
| Forest Investigative Site 1136 | |
| Cincinnati, Ohio, United States, 45227 | |
| Forest Investigative Site 2006 | |
| Columbus, Ohio, United States, 43215 | |
| Forest Investigative Site 0959 | |
| 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 1171 | |
| Toronto, Ontario, Canada, M5T 3A9 | |
| Forest Investigative Site 2203 | |
| Toronto, Ontario, Canada, M6H 3M2 | |
| Forest Investigative Site 1168 | |
| Toronto, Ontario, Canada, M5G 1N8 | |
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 Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases |
Bromides Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013