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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Aclidinium bromide dose, inhaled, for 52 weeks of treatment |
|
| 2 | Experimental | Aclidinium bromide dose, inhaled, for 52 weeks of treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium bromide | Drug | Aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peak FEV1 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 1162 | Birmingham | Alabama | 35209 | United States | ||
| Forest Investigative Site 1127 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23679347 | Derived | D'Urzo A, Kerwin E, Rennard S, He T, Gil EG, Caracta C. One-year extension study of ACCORD COPD I: safety and efficacy of two doses of twice-daily aclidinium bromide in patients with COPD. COPD. 2013 Aug;10(4):500-10. doi: 10.3109/15412555.2013.791809. Epub 2013 May 16. |
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From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent To Treat (ITT) Population.
Patient recruitment occurred from August of 2009 to March of 2010 and was by invitation only to patients who had completed study NCT00891462 (LAS-MD-33). In total, there were 77 individual study sites, 71 in the United States and 6 additional sites in Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium Bromide 200 μg | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| FG001 | Aclidinium Bromide 400 μg | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Aclidinium bromide | Drug | Aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment |
|
| Mobile |
| Alabama |
| 36608 |
| United States |
| Forest Investigative Site 0909 | Glendale | Arizona | 85306 | United States |
| Forest Investigative Site 2060 | Phoenix | Arizona | 85023 | United States |
| Forest Investigative Site 2065 | Fullerton | California | 92835 | United States |
| Forest Investigative Site 1088 | Lakewood | California | 90712 | United States |
| Forest Investigative Site 1122 | Orange | California | 92868 | United States |
| Forest Investigative Site 2029 | Rancho Mirage | California | 92270 | United States |
| Forets Investigative Site 2064 | Riverside | California | 92506 | United States |
| Forest Investigative Site 0517 | Sacramento | California | 95821 | United States |
| Forest Investigative Site 2009 | San Diego | California | 92120 | United States |
| Forest Investigative Site 1137 | Colorado Springs | Colorado | 80907 | United States |
| Forest Investigative Site 2100 | Waterbury | Connecticut | 06708 | United States |
| Forest Investigative Site 1154 | Brandon | Florida | 33511 | United States |
| Forest Investigative Site 1152 | Clearwater | Florida | 33765 | United States |
| Forest Investigative Site 0670 | DeLand | Florida | 32720 | United States |
| Forest Investigative Site 0990 | Fort Lauderdale | Florida | 33316 | United States |
| Forest Investigative Site 1167 | Melbourne | Florida | 32935 | United States |
| Forest Investigative Site 1060 | Ormond Beach | Florida | 32174 | United States |
| Forest Investigative Site 0974 | Pensacola | Florida | 32504 | United States |
| Forest Investigative Site 2082 | Tamarac | Florida | 33321 | United States |
| Forest Investigative Site 2053 | Tampa | Florida | 33606 | United States |
| Forest Investigative Site 2047 | Tampa | Florida | 33613 | United States |
| Forest Investigative Site 1185 | Winter Park | Florida | 32789 | United States |
| Forest Investigative Site 1183 | Atlanta | Georgia | 30329 | United States |
| Forest Investigative Site 0987 | Austell | Georgia | 30106 | United States |
| Forest Investigative Site 1101 | Blue Ridge | Georgia | 30513 | United States |
| Forest Investigative Site 1180 | Decatur | Georgia | 30033 | United States |
| Forest Investigative Site 1161 | Duluth | Georgia | 30096 | United States |
| Forest Investigative Site 2051 | River Forest | Illinois | 60305 | United States |
| Forest Investigative Site 0989 | Skokie | Illinois | 60076 | United States |
| Forest Investigative Site 1149 | South Bend | Indiana | 46617 | United States |
| Forest Investigative Site 2085 | Crescent Springs | Kentucky | 41017 | United States |
| Forest Investigative Site 0539 | Lexington | Kentucky | 40504 | United States |
| Forest Investigative Site 2024 | Lafayette | Louisiana | 70503 | United States |
| Forest Investigative Site 2040 | Biddeford | Maine | 04005 | United States |
| Forest Investigative Site 1128 | Edina | Minnesota | 55435 | United States |
| Forest Investigative Site 2041 | Minneapolis | Minnesota | 55402 | United States |
| Forest Investigative Site 1124 | Minneapolis | Minnesota | 55407 | United States |
| Forest Investigative Site 1100 | Florissant | Missouri | 63033 | United States |
| Forest Investigative Site 2079 | Saint Charles | Missouri | 63301 | United States |
| Forest Investigative Site 2067 | Butte | Montana | 59701 | United States |
| Forest Investigative Site 1169 | Papillion | Nebraska | 68406 | United States |
| Forest Investigative Site 1150 | Berlin | New Jersey | 08009 | United States |
| Forest Investigative Site 2084 | Summit | New Jersey | 07901 | United States |
| Forest Investigative Site 1147 | Brooklyn | New York | 11234 | United States |
| Forest Investigative Site 1119 | Elmira | New York | 14901 | United States |
| Forest Investigative Site 1151 | New Hyde Park | New York | 11040 | United States |
| Forest Investigative Site 1141 | New York | New York | 10016 | United States |
| Forest Investigative Site 1163 | New York | New York | 10016 | United States |
| Forest Investigative Site 1130 | Asheville | North Carolina | 28801 | United States |
| Forest Investigative Site 1134 | Canton | Ohio | 44718 | United States |
| Forest Investigative Site 1181 | Centerville | Ohio | 45459 | United States |
| Forest Investigative Site 1136 | Cincinnati | Ohio | 45227 | United States |
| Forest Investigative Site 2007 | Cincinnati | Ohio | 45231 | United States |
| Forest Investigative Site 2028 | Cincinnati | Ohio | 45242 | United States |
| Forest Investigative Site 0959 | Columbus | Ohio | 43215 | United States |
| Forest Investigative Site 2006 | Columbus | Ohio | 43215 | United States |
| Forest Investigative Site 2043 | Medford | Oregon | 97504 | United States |
| Forest Investigative Site 1106 | Portland | Oregon | 97213 | United States |
| Forest Investigative Site 1126 | Bethlehem | Pennsylvania | 18020 | United States |
| Forest Investigative Site 2016 | Erie | Pennsylvania | 16506 | United States |
| Forest Investigative Site 1146 | Pittsburgh | Pennsylvania | 15243 | United States |
| Forest Investigative Site 1158 | Upland | Pennsylvania | 19013 | United States |
| Forest Investigative Site 1089 | East Providence | Rhode Island | 02914 | United States |
| Forest Investigative Site 1144 | Johnston | Rhode Island | 02919 | United States |
| Forest Investigative Site 2072 | Charleston | South Carolina | 29406 | United States |
| Forest Investigative Site 1078 | Greenville | South Carolina | 29615 | United States |
| Forest Investigative Site 2080 | Greer | South Carolina | 29651 | United States |
| Forest Investigative Site 1121 | Spartanburg | South Carolina | 29303 | United States |
| Forest Investigative Site 1155 | Dallas | Texas | 75231 | United States |
| Forest Investigative Site 2012 | Fort Worth | Texas | 76104 | United States |
| Forest Investigative Site 1165 | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site 1129 | Waco | Texas | 76712 | United States |
| Forest Investigative Site 2099 | Richmond | Virginia | 23225 | United States |
| Forest Investigative Site 1142 | Spokane | Washington | 99204 | United States |
| Forest Investigative Site 0988 | Tacoma | Washington | 98405 | United States |
| Forest Investigative Site 2201 | Kelowna | British Columbia | V1Y 8E7 | Canada |
| Forest Investigative Site 1177 | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Forest Investigative Site 2200 | Niagara Falls | Ontario | L2g 1J4 | Canada |
| Forest Investigative Site 1168 | Toronto | Ontario | M5G 1N8 | Canada |
| Forest Investigative Site 1171 | Toronto | Ontario | M5T 3A9 | Canada |
| Forest Investigative Site 2203 | Toronto | Ontario | M6H 3M2 | Canada |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aclidinium Bromide 200 μg | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| BG001 | Aclidinium Bromide 400 μg | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) | 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 | From the total of 291 patients enrolled, 289 patients (99.3%) received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 246 (84.5%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population | Posted | Least Squares Mean | Standard Error | L | Change from baseline (visit 2 of lead-in study LAS-MD-33) to 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Peak FEV1 | 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]). | Posted | Least Squares Mean | Standard Error | L | 52 weeks |
|
Adverse Event Reporting occurred from August 2009 to November 2010 at 77 study sites (71 in the United States and 6 additional sites in Canada).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo to Aclidinium Bromide 200 μg | Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment | 7 | 44 | 36 | 44 | ||
| EG001 | Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg | Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment. | 13 | 93 | 63 | 93 | ||
| EG002 | Placebo to Aclidinium Bromide 400μg | Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment | 7 | 46 | 28 | 46 | ||
| EG003 | Aclidinium Bromide 400μg to Aclidinium Bromide 400μg | Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment. | 13 | 106 | 64 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Breast cancer stage II | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspepsia | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Lung squamous cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Multiple drug overdose accidental | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Small cell lung cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA (13.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
|
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study.
Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and Forest Research Institute, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical | Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D029481 | Bronchitis, Chronic |
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
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| ≥ 60 to < 70 years |
|
| ≥ 70 years |
|
| Male |
|
| Canada |
|
Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
|
|