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| ID | Type | Description | Link |
|---|---|---|---|
| ACCORD COPD I |
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The purpose of this study is to assess the efficacy (effectiveness) and safety of aclidinium bromide doses as compared to placebo in the treatment of moderate to severe chronic obstructive pulmonary disease. The study will be 16 weeks in duration; 2-week run-in period, 12-week double-blind treatment, and 2-week follow-up phone visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Aclidinium bromide dose, inhaled, for 12 weeks of treatment |
|
| 2 | Experimental | Aclidinium bromide dose, inhaled, for 12 weeks of treatment |
|
| 3 | Placebo Comparator | Inhaled placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium bromide | Drug | Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Morning Pre-dose Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF) | Change from Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF) | Change from Baseline to 12 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 | Birmingham | Alabama | 35209 | United States | ||
| Forest Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28074135 | Derived | McGarvey L, Morice AH, Smith JA, Birring SS, Chuecos F, Seoane B, Jarreta D. Effect of aclidinium bromide on cough and sputum symptoms in moderate-to-severe COPD in three phase III trials. BMJ Open Respir Res. 2016 Dec 8;3(1):e000148. doi: 10.1136/bmjresp-2016-000148. eCollection 2016. | |
| 22320148 | Derived | Kerwin EM, D'Urzo AD, Gelb AF, Lakkis H, Garcia Gil E, Caracta CF; ACCORD I study investigators. Efficacy and safety of a 12-week treatment with twice-daily aclidinium bromide in COPD patients (ACCORD COPD I). COPD. 2012 Apr;9(2):90-101. doi: 10.3109/15412555.2012.661492. Epub 2012 Feb 9. |
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From the total of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population.
Patient recruitment occurred from April to July of 2009 at 106 study sites, (100 in the United States and 6 additional sites in Canada.) A total of 99 study sites randomized patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Inhaled placebo for 12 weeks |
| FG001 | Aclidinium Bromide, 200µg | Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 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 12 weeks of treatment |
|
| Placebo | Drug | Dose-matched placebo, oral inhalation twice per day for 12 weeks of treatment |
|
| Jasper |
| Alabama |
| 35501 |
| United States |
| Forest Investigative Site | Mobile | Alabama | 18020 | United States |
| Forest Investigative Site | Mesa | Arizona | 85210 | United States |
| Forest Investigative Site | Phoenix | Arizona | 85006 | United States |
| Forest Investigative Site | Phoenix | Arizona | 85023 | United States |
| Forest Investigative Site | Anaheim | California | 92801 | United States |
| Forest Investigative Site | Encinitas | California | 92024 | United States |
| Forest Investigative Site | Fresno | California | 93726 | United States |
| Forest Investigative Site | Fullerton | California | 92835 | United States |
| Forest Investigative Site | Lakewood | California | 90712 | United States |
| Forest Investigative Site | Orange | California | 92868 | United States |
| Forest Investigative Site | Palo Alto | California | 94304 | United States |
| Forest Investigative Site | Rancho Mirage | California | 92270 | United States |
| Forest Investigative Site | Sacramento | California | 95831 | United States |
| Forest Investigative Site | San Diego | California | 92103-8415 | United States |
| Forest Investigative Site | San Diego | California | 92120 | United States |
| Forest Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Forest Investigative Site | Denver | Colorado | 80206 | United States |
| Forest Investigative Site | Wheat Ridge | Colorado | 80033 | United States |
| Forest Investigative Site | Waterbury | Connecticut | 06708 | United States |
| Forest Investigative Site | Brandon | Florida | 33511 | United States |
| Forest Investigative Site | Clearwater | Florida | 33765 | United States |
| Forest Investigative Site | DeLand | Florida | 32720 | United States |
| Forest Investigative Site | Fort Lauderdale | Florida | 33316 | United States |
| Forest Investigative Site | Melbourne | Florida | 32901 | United States |
| Forest Investigative Site | Melbourne | Florida | 32935 | United States |
| Forest Investigative Site | Ormond Beach | Florida | 32174 | United States |
| Forest Investigative Site | Panama City | Florida | 32405 | United States |
| Forest Investigative Site | Pensacola | Florida | 32504 | United States |
| Forest Investigative Site | Tamarac | Florida | 33321 | United States |
| Forest Investigative Site | Tampa | Florida | 33603 | United States |
| Forest Investigative Site | Tampa | Florida | 33613 | United States |
| Forest Investigative Site | Austell | Georgia | 30106 | United States |
| Forest Investigative Site | Blue Ridge | Georgia | 30513 | United States |
| Forest Investigative Site | Duluth | Georgia | 30096 | United States |
| Forest Investigative Site | Marietta | Georgia | 30060 | United States |
| Forest Investigative Site | River Forest | Illinois | 60305 | United States |
| Forest Investigative Site | Skokie | Illinois | 60076 | United States |
| Forest Investigative Site | South Bend | Indiana | 46617 | United States |
| Forest Investigative Site | Crescent Springs | Kentucky | 41017 | United States |
| Forest Investigative Site | Lexington | Kentucky | 40504 | United States |
| Forest Investigative Site | Lafayette | Louisiana | 70503 | United States |
| Forest Investigative Site | Bangor | Maine | 04401 | United States |
| Forest Investigative Site | Baltimore | Maryland | 21201 | United States |
| Forest Investigative Site | Baltimore | Maryland | 21224 | United States |
| Forest Investigative Site | Hagerstown | Maryland | 21740 | United States |
| Forest Investigative Site | North Dartmouth | Massachusetts | 02747 | United States |
| Forest Investigative Site | Livonia | Michigan | 48152 | United States |
| Forest Investigative Site | Edina | Minnesota | 55435 | United States |
| Forest Investigative Site | Minneapolis | Minnesota | 55402 | United States |
| Forest Investigative Site | Minneapolis | Minnesota | 55407 | United States |
| Forest Investigative Site | Florissant | Missouri | 63033 | United States |
| Forest Investigative Site | Saint Charles | Missouri | 63301 | United States |
| Forest Investigative Site | Billings | Montana | 59102 | United States |
| Forest Investigative Site | Butte | Montana | 59701 | United States |
| Forest Investigative Site | Papillion | Nebraska | 68046 | United States |
| Forest Investigative Site | Berlin | New Jersey | 08009 | United States |
| Forest Investigative Site | Summit | New Jersey | 07901 | United States |
| Forest Investigative Site | Brooklyn | New York | 11234 | United States |
| Forest Investigative Site | Buffalo | New York | 14215 | United States |
| Forest Investigative Site | Great Neck | New York | 11023 | United States |
| Forest Investigative Site | Ithaca | New York | 14580 | United States |
| Forest Investigative Site | New Hyde Park | New York | 11040 | United States |
| Forest Investigative Site | New York | New York | 10004 | United States |
| Forest Investigative Site | New York | New York | 10016 | United States |
| Forest Investigative Site | Asheville | North Carolina | 28801 | United States |
| Forest Investigative Site | Charlotte | North Carolina | 28207 | United States |
| Forest Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Forest Investigative Site | Canton | Ohio | 44718 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45227 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45231 | United States |
| Forest Investigative Site | Cincinnati | Ohio | 45242 | United States |
| Forest Investigative Site | Columbus | Ohio | 43215 | United States |
| Forest Investigative Site | Toledo | Ohio | 43606 | United States |
| Forest Investigative Site | Oklahoma City | Oklahoma | 73120 | United States |
| Forest Investigative Site | Medford | Oregon | 97504 | United States |
| Forest Investigative Site | Portland | Oregon | 97213 | United States |
| Forest Investigative Site | Bethlehem | Pennsylvania | 18020 | United States |
| Forest Investigative Site | Erie | Pennsylvania | 16506 | United States |
| Forest Investigative Site | Hershey | Pennsylvania | 17033 | United States |
| Forest Investigative Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Forest Investigative Site | Upland | Pennsylvania | 19013 | United States |
| Forest Investigative Site | East Providence | Rhode Island | 02914 | United States |
| Forest Investigative Site | Johnston | Rhode Island | 02919 | United States |
| Forest Investigative Site | Charleston | South Carolina | 29406 | United States |
| Forest Investigative Site | Greenville | South Carolina | 29615 | United States |
| Forest Investigative Site | Greer | South Carolina | 29651 | United States |
| Forest Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Forest Investigative Site | Nashville | Tennessee | 37232-2650 | United States |
| Forest Investigative Site | Dallas | Texas | 75231 | United States |
| Forest Investigative Site | Dallas | Texas | 75246 | United States |
| Forest Investigative Site | Fort Worth | Texas | 76104 | United States |
| Forest Investigative Site | Houston | Texas | 77024 | United States |
| Forest Investigative Site | San Antonio | Texas | 78229 | United States |
| Forest Investigative Site | Tyler | Texas | 75708 | United States |
| Forest Investigative Site | Waco | Texas | 76712 | United States |
| Forest Investigative Site | Midvale | Utah | 84047 | United States |
| Forest Investigative Site | Richmond | Virginia | 23225 | United States |
| Forest Investigative Site | Richmond | Virginia | 23249 | United States |
| Forest Investigative Site | Bellingham | Washington | 98225 | United States |
| Forest Investigative Site | Spokane | Washington | 99204 | United States |
| Forest Investigative Site | Tacoma | Washington | 98405 | United States |
| Forest Investigative Site | Milwaukee | Wisconsin | 53209 | United States |
| Forest Investigative Site | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Forest Investigative Site | Edmonton | T5J 3S9 | Canada |
| Forest Investigative Site | Hamilton | L8N 4A6 | Canada |
| Forest Investigative Site | Kelowna | V1Y 8E7 | Canada |
| Forest Investigative Site | Niagara Falls | L2G 1J4 | Canada |
| Forest Investigative Site | Sainte-Foy | G1V 4G5 | Canada |
| Forest Investigative Site | Toronto | M5g 1N8 | Canada |
| Forest Investigative Site | Toronto | M6H 3M2 | Canada |
| FG002 | Aclidinium Bromide, 400µg | Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Inhaled placebo for 12 weeks |
| BG001 | Aclidinium Bromide, 200µg | Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment |
| BG002 | Aclidinium Bromide, 400µg | Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment. |
| BG003 | 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 Forced Expiratory Volume in 1 Second (FEV1) | Change from baseline in trough forced expiratory volume in 1 second before the morning dose of aclidinium bromide, Last Observation Carried Forward (LOCF) | Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population. | Posted | Least Squares Mean | Standard Error | L | Change from Baseline to 12 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) | Change From Baseline in Peak FEV1 (L) at Week 12, Last Observation Carried Forward (LOCF) | Of 561 patients randomized, 560 patients received at least 1 dose of double-blind treatment and therefore were included in the Safety Population. Of these patients, 559 had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the Intent to Treat (ITT) Population. The primary efficacy endpoint was based on ITT population. | Posted | Least Squares Mean | Standard Error | L | Change from Baseline to 12 weeks |
|
Adverse events reporting occurred from April 28th, 2009 to December 3rd, 2009 at 99 study sites.
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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 | Inhaled placebo for 12 weeks | 4 | 186 | 23 | 186 | ||
| EG001 | Aclidinium Bromide, 200µg | Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment | 8 | 184 | 17 | 184 | ||
| EG002 | Aclidinium Bromide, 400µg | Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment. | 6 | 190 | 14 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lung cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Abdominal hernia obstructive | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.1) | Systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
| |
| Still's disease adult onset | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (12.1) | 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.
| 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 |
Not provided
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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
Not provided
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| ≥ 60 to < 70 years |
|
| ≥ 70 years |
|
| Male |
|
| Canada |
|
| Least Squares Mean Difference |
| 0.124 |
| 2-Sided |
| 95 |
| 0.08 |
| 0.16 |
| No |
| Superiority or Other |
| Units |
|---|
| Counts |
|---|
| Participants |
|
|