Long-term Safety, Tolerability and Efficacy of Aclidinium Bromide in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (LAS-MD-35)
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01044459
Collaborator
(none)
605
113
2
17
5.4
0.3
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of inhaled aclidinium bromide at two dose levels in patients with moderate to severe, stable chronic obstructive pulmonary disease. The study will be 56 weeks in duration; a 2-week rin-in period, a 52-week treatment period and a 2-week follow up phone call. All patients will be randomized to one of two doses of aclidinium bromide.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
605 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Long-Term, Randomized, Double-Blind Study of the Safety, Tolerability and Efficacy of Aclidinium Bromide At Two Dosage Levels When Administered to Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease
Study Start Date
:
Nov 1, 2009
Actual Primary Completion Date
:
Apr 1, 2011
Actual Study Completion Date
:
Apr 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Aclidinium Bromide 200 µg aclidinium bromide, inhaled, 52 weeks of treatment |
Drug: Aclidinium Bromide 200 µg
aclidinium bromide 200 μg, oral inhalation twice per day for 52 weeks of treatment
|
| Experimental: Aclidinium Bromide 400 µg aclidinium bromide, inhaled, 52 weeks of treatment |
Drug: Aclidinium Bromide 400 µg
aclidinium bromide 400 μg, oral inhalation twice per day for 52 weeks of treatment
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) [From baseline to 52 weeks]
Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52.
Secondary Outcome Measures
- Change From Baseline in Peak FEV1 [52 weeks]
Change From Baseline in Peak FEV1 in liters at Week 52.
Eligibility Criteria
Criteria
Ages Eligible for Study:
40 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
A diagnosis of stable moderate to severe COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2010; postbronchodilator FEV1/FVC < 70%, and postbronchodilator FEV1 ≥ 30% and < 80% predicted
-
Current or former cigarette smokers
Exclusion Criteria:
-
Patients who have been hospitalized for an acute COPD exacerbation within 3 months before the first visit
-
Respiratory tract infection or COPD exacerbation in the 6 weeks before Visit 1
-
Patient with any clinically significant respiratory conditions other than COPD, cardiovascular conditions or mental illness
-
History or presence of asthma verified from medical records
-
Chronic use of oxygen therapy greater than or equal to 15 hours per day
-
Patient with uncontrolled infection due to HIV and/or active hepatitis
-
Patients with a history of hypersensitivity reaction to inhaled anticholinergics
-
Patients with clinically significant cardiovascular conditions, including myocardial infarction during the previous 6 months, newly diagnosed arrhythmia within the previous 3 months, unstable angina, unstable arrhythmia that had required changes in pharmacological therapy or other intervention.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Forest Investigative Site 1162 | Birmingham | Alabama | United States | 35209 |
| 2 | Forest Investigative Site 1127 | Mobile | Alabama | United States | 36608 |
| 3 | Forest Investigative Site 1475 | Scottsdale | Arizona | United States | 85258 |
| 4 | Forest Investigative Site 1338 | Tempe | Arizona | United States | 85282 |
| 5 | Forest Investigative Site 1349 | Tucson | Arizona | United States | 85710 |
| 6 | Forest Investigative Site 1483 | Buena Park | California | United States | 90620 |
| 7 | Forest Investigative Site 1350 | Foothill Ranch | California | United States | 92610 |
| 8 | Forest Investigative Site 1509 | Fresno | California | United States | 93720 |
| 9 | Forest Investigative Site 2065 | Fullerton | California | United States | 92835 |
| 10 | Forest Investigative Site 1502 | Huntington Park | California | United States | 90255 |
| 11 | Forest Investigative Site 1088 | Lakewood | California | United States | 90712 |
| 12 | Forest Investigative Site 1534 | Long Beach | California | United States | 90813 |
| 13 | Forest Investigative Site 2209 | Los Angeles | California | United States | 90095 |
| 14 | Forest Investigative Site 1122 | Orange | California | United States | 92868 |
| 15 | Forest Investigative Site 1508 | Palm Springs | California | United States | 92262 |
| 16 | Forest Investigative Site 2064 | Riverside | California | United States | 92506 |
| 17 | Forest Investigative Site 1533 | Sacramento | California | United States | 95825 |
| 18 | Forest Investigative Site 2009 | San Diego | California | United States | 92120 |
| 19 | Forest Investigative Site 1439 | San Diego | California | United States | 92123 |
| 20 | Forest Investigative Site 1503 | San Diego | California | United States | 92928 |
| 21 | Forest Investigative Site 1347 | San Jose | California | United States | 95117 |
| 22 | Forest Investigative Site 1344 | Spring Valley | California | United States | 91978 |
| 23 | Forest Investigative Site 2039 | Walnut Creek | California | United States | 94598 |
| 24 | Forest Investigative Site 2037 | Fort Collins | Colorado | United States | 80528 |
| 25 | Forest Investigative Site 1327 | Wheat Ridge | Colorado | United States | 80033 |
| 26 | Forest Investigative Site 1104 | Hartford | Connecticut | United States | 06105 |
| 27 | Forest Investigative Site 1482 | Stamford | Connecticut | United States | 06902-3633 |
| 28 | Forest Investigative Site 1346 | Newark | Delaware | United States | 19713 |
| 29 | Forest Investigative Site 1154 | Brandon | Florida | United States | 33511 |
| 30 | Forest Investigative Site 1152 | Clearwater | Florida | United States | 33765 |
| 31 | Forest Investigative Site 1514 | Coral Gables | Florida | United States | 33134 |
| 32 | Forest Investigative Site 0670 | DeLand | Florida | United States | 32720 |
| 33 | Forest Investigative Site 1516 | Edgewater | Florida | United States | 32141 |
| 34 | Forest Investigative Site 0990 | Fort Lauderdale | Florida | United States | 33316 |
| 35 | Forest Investigative Site 1513 | Hialeah | Florida | United States | 33102 |
| 36 | Forest Investigative Site 1420 | Miami | Florida | United States | 33133 |
| 37 | Forest Investigative Site 1432 | Miami | Florida | United States | 33143 |
| 38 | Forest Investigative Site 1484 | Miramar | Florida | United States | 33025 |
| 39 | Forest Investigative Site 1340 | Ocala | Florida | United States | 34471 |
| 40 | Forest Investigative Site 1488 | Pembroke Pines | Florida | United States | 33027 |
| 41 | Forest Investigative Site 0974 | Pensacola | Florida | United States | 32504 |
| 42 | Forest Investigative Site 1397 | Port Charlotte | Florida | United States | 33952 |
| 43 | Forest Investigative Site 1383 | Port Orange | Florida | United States | 32127 |
| 44 | Forest Investigative Site 2082 | Tamarac | Florida | United States | 33321 |
| 45 | Forest Investigative Site 2047 | Tampa | Florida | United States | 33613 |
| 46 | Forest Investigative Site 1395 | Valrico | Florida | United States | 33596 |
| 47 | Forest Investigative Site 0980 | Atlanta | Georgia | United States | 30342 |
| 48 | Forest Investigative Site 1491 | Atlanta | Georgia | United States | 30342 |
| 49 | Forest Investigative Site 0987 | Austell | Georgia | United States | 30106 |
| 50 | Forest Investigative Site 1532 | Columbus | Georgia | United States | 31904 |
| 51 | Forest Investigative Site 2051 | River Forest | Illinois | United States | 60305 |
| 52 | Forest Investigative Site 0989 | Skokie | Illinois | United States | 60076 |
| 53 | Forest Investigative Site 1436 | Avon | Indiana | United States | 46123 |
| 54 | Forest Investigative Site 2085 | Crescent Springs | Kentucky | United States | 41017 |
| 55 | Forest Investigative Site 1520 | Crestview Hills | Kentucky | United States | 41017 |
| 56 | Forest Investigative Site 0539 | Lexington | Kentucky | United States | 40504 |
| 57 | Forest Investigative Site 1336 | Louisville | Kentucky | United States | 40215 |
| 58 | Forest Investigative Site 1478 | Louisville | Kentucky | United States | 40217 |
| 59 | Forest Investigative Site 2024 | Lafayette | Louisiana | United States | 70503 |
| 60 | Forest Investigative Site 1333 | Baltimore | Maryland | United States | 21236 |
| 61 | Forest Investigative Site 1421 | Fall River | Massachusetts | United States | 02720 |
| 62 | Forest Investigative Site 1342 | Stevensville | Michigan | United States | 49127 |
| 63 | Forest Investigative Site 1438 | Ypsilanti | Michigan | United States | 48197 |
| 64 | Forest Investigative Site 2041 | Minneapolis | Minnesota | United States | 55402 |
| 65 | Forest Investigative Site 1351 | Plymouth | Minnesota | United States | 55441 |
| 66 | Forest Investigative Site 1100 | Florissant | Missouri | United States | 63033 |
| 67 | Forest Investigative Site 2079 | St. Charles | Missouri | United States | 63301 |
| 68 | Forest Investigative Site 1343 | St. Louis | Missouri | United States | 63128 |
| 69 | Forest Investigative Site 1329 | St. Louis | Missouri | United States | 63141 |
| 70 | Forest Investigative Site 1369 | St. Louis | Missouri | United States | 63141 |
| 71 | Forest Investigative Site 1335 | St. Louis | Missouri | United States | 63143 |
| 72 | Forest Investigative Site 1367 | Papillion | Nebraska | United States | 68046 |
| 73 | Forest Investigative Site 1150 | Berlin | New Jersey | United States | 09009 |
| 74 | Forest Investigative Site 1339 | Cherry Hill | New Jersey | United States | 08003 |
| 75 | Forest Investigative Site 1515 | Elizabeth | New Jersey | United States | 07202 |
| 76 | Forest Investigative Site 1394 | Ocean | New Jersey | United States | 07712 |
| 77 | Forest Investigative Site 2062 | Bronxville | New York | United States | 10708 |
| 78 | Forest Investigative Site 1368 | Bronx | New York | United States | 10457 |
| 79 | Forest Investigative Site 1147 | Brooklyn | New York | United States | 11234 |
| 80 | Forest Investigative Site 1151 | New Hyde Park | New York | United States | 11040 |
| 81 | Forest Investigative Site 1114 | New York | New York | United States | 10010 |
| 82 | Forest Investigative Site 1163 | New York | New York | United States | 10016 |
| 83 | Forest Investigative Site 1481 | Newburgh | New York | United States | 12550 |
| 84 | Forest Investigative Site 0479 | Rochester | New York | United States | 14618 |
| 85 | Forest Investigative Site 2081 | Charlotte | North Carolina | United States | 28207 |
| 86 | Forest Investigative Site 1334 | Charlotte | North Carolina | United States | 28226 |
| 87 | Forest Investigative Site 1366 | HighPoint | North Carolina | United States | 27262 |
| 88 | Forest Investigative Site 1382 | Statesville | North Carolina | United States | 28625 |
| 89 | Forest Investigative Site 1134 | Canton | Ohio | United States | 44718 |
| 90 | Forest Investigative Site 2007 | Cincinnati | Ohio | United States | 45231 |
| 91 | Forest Investigative Site 1434 | Cleveland | Ohio | United States | 44122 |
| 92 | Forest Investigative Site 1433 | Columbus | Ohio | United States | 43213 |
| 93 | Forest Investigative Site 0959 | Columbus | Ohio | United States | 43214 |
| 94 | Forest Investigative Site 1505 | Columbus | Ohio | United States | 43235 |
| 95 | Forest Investigative Site 1435 | Dayton | Ohio | United States | 45406 |
| 96 | Forest Investigative Site 1348 | Bend | Oregon | United States | 97701 |
| 97 | Forest Investigative Site 1504 | Hershey | Pennsylvania | United States | 17033 |
| 98 | Forest Investigative Site 2072 | Charleston | South Carolina | United States | 29406 |
| 99 | Forest Investigative Site 0900 | Spartanburg | South Carolina | United States | 29303 |
| 100 | Forest Investigative Site 1365 | Rapid City | South Dakota | United States | 57702 |
| 101 | Forest Investigative Site 0962 | Nashville | Tennessee | United States | 37232 |
| 102 | Forest Investigative Site 1155 | Dallas | Texas | United States | 75231 |
| 103 | Forest Investigative Site 1328 | Dallas | Texas | United States | 75231 |
| 104 | Forest Investigative Site 1332 | El Paso | Texas | United States | 79903 |
| 105 | Forest Investigative Site 1337 | Houston | Texas | United States | 77054 |
| 106 | Forest Investigative Site 1396 | San Antonio | Texas | United States | 78125 |
| 107 | Forest Investigative Site 1384 | San Antonio | Texas | United States | 78328 |
| 108 | Forest Investigative Site 1330 | South Burlington | Vermont | United States | 05403 |
| 109 | Forest Investigative Site 1120 | Bellingham | Washington | United States | 98225 |
| 110 | Forest Investigative Site 1531 | Tacoma | Washington | United States | 98405 |
| 111 | Forest Investigative Site 2201 | Kelowna | British Columbia | Canada | V1Y 8E7 |
| 112 | Forest Investigative Site 1157 | Toronto | Ontario | Canada | M3H 5S4 |
| 113 | Forest Investigative Site 1168 | Toronto | Ontario | Canada | M5G 1N8 |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Esther Garcia, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01044459
Other Study ID Numbers:
- LAS-MD-35
First Posted:
Jan 7, 2010
Last Update Posted:
Apr 20, 2017
Last Verified:
Feb 1, 2017
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Patient recruitment occurred from November of 2009 to April of 2010 at 109 study sites (106 sites in the United States and 3 additional sites in Canada). A total of 97 study sites randomized patients (94 in the United States and 3 in Canada). |
|---|---|
| Pre-assignment Detail | A 2-week run-in period was used to assess the stability of patients' disease and to establish each patient's baseline characteristics. The run-in period was followed by a 52-week double-blind treatment period. |
| Arm/Group Title | Aclidinium Bromide 200µg | Aclidinium Bromide 400µg |
|---|---|---|
| Arm/Group Description | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| Period Title: Overall Study | ||
| STARTED | 312 | 293 |
| COMPLETED | 179 | 162 |
| NOT COMPLETED | 133 | 131 |
Baseline Characteristics
| Arm/Group Title | Aclidinium Bromide 200µg | Aclidinium Bromide 400µg | Total |
|---|---|---|---|
| Arm/Group Description | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | Total of all reporting groups |
| Overall Participants | 311 | 291 | 602 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.0
(9.5)
|
64.2
(9.9)
|
63.6
(9.7)
|
| Age, Customized (participants) [Number] | |||
| ≥ 40 to < 60 years |
113
36.3%
|
96
33%
|
209
34.7%
|
| ≥ 60 to < 70 years |
115
37%
|
99
34%
|
214
35.5%
|
| ≥ 70 years |
83
26.7%
|
96
33%
|
179
29.7%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
127
40.8%
|
124
42.6%
|
251
41.7%
|
| Male |
184
59.2%
|
167
57.4%
|
351
58.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
305
98.1%
|
284
97.6%
|
589
97.8%
|
| Canada |
6
1.9%
|
7
2.4%
|
13
2.2%
|
Outcome Measures
| Title | Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1) |
|---|---|
| Description | Change From Baseline in Morning Predose (Trough) FEV1 in liters at Week 52. |
| Time Frame | From baseline to 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study. |
| Arm/Group Title | Aclidinium Bromide 200µg | Aclidinium Bromide 400µg |
|---|---|---|
| Arm/Group Description | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| Measure Participants | 310 | 290 |
| Least Squares Mean (Standard Error) [L] |
0.034
(0.015)
|
0.072
(0.015)
|
| Title | Change From Baseline in Peak FEV1 |
|---|---|
| Description | Change From Baseline in Peak FEV1 in liters at Week 52. |
| Time Frame | 52 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population. Of these 602 patients, 600 (99.2%) had a baseline and at least 1 postbaseline FEV1 assessment and qualified for the ITT Population. A decision to terminate one site was made before unblinding of the study. |
| Arm/Group Title | Aclidinium Bromide 200µg | Aclidinium Bromide 400µg |
|---|---|---|
| Arm/Group Description | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. |
| Measure Participants | 310 | 290 |
| Least Squares Mean (Standard Error) [L] |
0.185
(0.015)
|
0.214
(0.015)
|
Adverse Events
| Time Frame | Adverse event reporting occurred from November 2009 to May 2011 at 97 study sites (94 in the United States and 3 in Canada). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Of 605 patients randomized, 602 patients (99.5%) received at least 1 dose of double-blind treatment and were included in the Safety Population; 311 patients for aclidinium bromide 200µg and 291 patients for aclidinium bromide 400µg | |||
| Arm/Group Title | Aclidinium Bromide 200µg | Aclidinium Bromide 400µg | ||
| Arm/Group Description | Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment. | ||
All Cause Mortality |
||||
| Aclidinium Bromide 200µg | Aclidinium Bromide 400µg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Aclidinium Bromide 200µg | Aclidinium Bromide 400µg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 29/311 (9.3%) | 29/291 (10%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 0/311 (0%) | 1/291 (0.3%) | ||
| Cardiac disorders | ||||
| Acute Myocardial Infarction | 2/311 (0.6%) | 2/291 (0.7%) | ||
| Angina Pectoris | 0/311 (0%) | 1/291 (0.3%) | ||
| Atrial Fibrillation | 0/311 (0%) | 1/291 (0.3%) | ||
| Cadiac Failure Congestive | 0/311 (0%) | 1/291 (0.3%) | ||
| Acute coronary syndrome | 1/311 (0.3%) | 0/291 (0%) | ||
| Aortic valve incompetence | 1/311 (0.3%) | 0/291 (0%) | ||
| Coronary artery disease | 1/311 (0.3%) | 0/291 (0%) | ||
| Left atrial dilatation | 1/311 (0.3%) | 0/291 (0%) | ||
| Mitral valve stenosis | 1/311 (0.3%) | 0/291 (0%) | ||
| Myocardial infarction | 2/311 (0.6%) | 0/291 (0%) | ||
| Sick sinus syndrome | 1/311 (0.3%) | 0/291 (0%) | ||
| Ear and labyrinth disorders | ||||
| Vestibular disorder | 1/311 (0.3%) | 0/291 (0%) | ||
| Eye disorders | ||||
| Diplopia | 1/311 (0.3%) | 0/291 (0%) | ||
| Gastrointestinal disorders | ||||
| Colitis | 0/311 (0%) | 1/291 (0.3%) | ||
| Gastrointestinal Haemorrhage | 0/311 (0%) | 1/291 (0.3%) | ||
| Haematochezia | 0/311 (0%) | 1/291 (0.3%) | ||
| Intestinal Obstruction | 0/311 (0%) | 1/291 (0.3%) | ||
| Abdominal hernia | 1/311 (0.3%) | 0/291 (0%) | ||
| Abdominal pain | 1/311 (0.3%) | 0/291 (0%) | ||
| Constipation | 1/311 (0.3%) | 0/291 (0%) | ||
| Hiatus hernia | 1/311 (0.3%) | 0/291 (0%) | ||
| Intestinal ischaemia | 1/311 (0.3%) | 0/291 (0%) | ||
| Upper gastrointestinal haemorrhage | 1/311 (0.3%) | 0/291 (0%) | ||
| Hepatobiliary disorders | ||||
| Cholecystitis Chronic | 0/311 (0%) | 1/291 (0.3%) | ||
| Bile duct stenosis | 1/311 (0.3%) | 0/291 (0%) | ||
| Infections and infestations | ||||
| Pneumonia | 2/311 (0.6%) | 2/291 (0.7%) | ||
| Clostridial Infection | 0/311 (0%) | 1/291 (0.3%) | ||
| Haemophilus Infection | 0/311 (0%) | 1/291 (0.3%) | ||
| Lobar Pneumonia | 0/311 (0%) | 1/291 (0.3%) | ||
| Septic shock | 0/311 (0%) | 1/291 (0.3%) | ||
| Tracheobronchitis | 0/311 (0%) | 1/291 (0.3%) | ||
| Biliary sepsis | 1/311 (0.3%) | 0/291 (0%) | ||
| Diverticulitis | 1/311 (0.3%) | 0/291 (0%) | ||
| Sepsis syndrome | 1/311 (0.3%) | 0/291 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Fall | 1/311 (0.3%) | 1/291 (0.3%) | ||
| Femur Fracture | 0/311 (0%) | 1/291 (0.3%) | ||
| Thoracic vertebral fracture | 0/311 (0%) | 1/291 (0.3%) | ||
| Multiple drug overdose | 1/311 (0.3%) | 0/291 (0%) | ||
| Spinal compression fracture | 1/311 (0.3%) | 0/291 (0%) | ||
| Investigations | ||||
| Blood glucose increased | 1/311 (0.3%) | 0/291 (0%) | ||
| Electrocardiogram T wave inversion | 1/311 (0.3%) | 0/291 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 0/311 (0%) | 1/291 (0.3%) | ||
| Hyperglycaemia | 0/311 (0%) | 1/291 (0.3%) | ||
| Hypoglycaemia | 0/311 (0%) | 1/291 (0.3%) | ||
| Hyponatraemia | 0/311 (0%) | 1/291 (0.3%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 0/311 (0%) | 1/291 (0.3%) | ||
| Osteoarthritis | 0/311 (0%) | 1/291 (0.3%) | ||
| Flank pain | 1/311 (0.3%) | 0/291 (0%) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Lung Neoplasm Malignant | 0/311 (0%) | 1/291 (0.3%) | ||
| Metastases to Liver | 0/311 (0%) | 1/291 (0.3%) | ||
| Metastases to the mediastinum | 0/311 (0%) | 1/291 (0.3%) | ||
| Pharyngeal cancer metastatic | 0/311 (0%) | 1/291 (0.3%) | ||
| Lung adenocarcinoma | 1/311 (0.3%) | 0/291 (0%) | ||
| Lymphoma | 1/311 (0.3%) | 0/291 (0%) | ||
| Metastases to central nervous system | 1/311 (0.3%) | 0/291 (0%) | ||
| Non-small cell lung cancer | 1/311 (0.3%) | 0/291 (0%) | ||
| Oesophageal carcinoma | 1/311 (0.3%) | 0/291 (0%) | ||
| Transitional cell carcinoma | 1/311 (0.3%) | 0/291 (0%) | ||
| Nervous system disorders | ||||
| Carotid Artery Occlusion | 0/311 (0%) | 1/291 (0.3%) | ||
| Depressed Level of Consciousness | 0/311 (0%) | 1/291 (0.3%) | ||
| Hypoaesthesia | 0/311 (0%) | 1/291 (0.3%) | ||
| Subarachnoid haemorrhage | 0/311 (0%) | 1/291 (0.3%) | ||
| Syncope | 0/311 (0%) | 1/291 (0.3%) | ||
| Transient ischaemic attack | 0/311 (0%) | 1/291 (0.3%) | ||
| Cerebrovascular accident | 1/311 (0.3%) | 0/291 (0%) | ||
| Dizziness | 1/311 (0.3%) | 0/291 (0%) | ||
| Hemiparesis | 1/311 (0.3%) | 0/291 (0%) | ||
| Thermohypoaesthesia | 1/311 (0.3%) | 0/291 (0%) | ||
| Psychiatric disorders | ||||
| Anxiety | 0/311 (0%) | 1/291 (0.3%) | ||
| Depression | 0/311 (0%) | 1/291 (0.3%) | ||
| Suicidal ideation | 0/311 (0%) | 1/291 (0.3%) | ||
| Delirium | 1/311 (0.3%) | 0/291 (0%) | ||
| Drug dependence | 1/311 (0.3%) | 0/291 (0%) | ||
| Renal and urinary disorders | ||||
| Renal failure | 0/311 (0%) | 1/291 (0.3%) | ||
| Renal failure acute | 0/311 (0%) | 1/291 (0.3%) | ||
| Acute prerenal failure | 1/311 (0.3%) | 0/291 (0%) | ||
| Haematuria | 2/311 (0.6%) | 0/291 (0%) | ||
| Renal mass | 1/311 (0.3%) | 0/291 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic Obstructive Pulmonary Disease | 5/311 (1.6%) | 6/291 (2.1%) | ||
| Respiratory Failure | 1/311 (0.3%) | 2/291 (0.7%) | ||
| Pleural effusion | 0/311 (0%) | 1/291 (0.3%) | ||
| Pneumonia pneumococcal | 0/311 (0%) | 1/291 (0.3%) | ||
| Pneumothorax | 0/311 (0%) | 1/291 (0.3%) | ||
| Atelectasis | 1/311 (0.3%) | 0/291 (0%) | ||
| Dyspnoea | 1/311 (0.3%) | 0/291 (0%) | ||
| Hypoxia | 1/311 (0.3%) | 0/291 (0%) | ||
| Pulmonary embolism | 2/311 (0.6%) | 0/291 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Hyperhidrosis | 1/311 (0.3%) | 0/291 (0%) | ||
| Vascular disorders | ||||
| Peripheral arterial occlusive disease | 0/311 (0%) | 1/291 (0.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Aclidinium Bromide 200µg | Aclidinium Bromide 400µg | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 60/311 (19.3%) | 58/291 (19.9%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Chronic Obstructive Pulmonary Disease | 60/311 (19.3%) | 58/291 (19.9%) | ||
Limitations/Caveats
Site 1420 randomized 31 patients who were discontinued by 21 Jan 2011 due to significant deviations documented in a letter to the FDA on 07 Jan 2011. No changes to the analyses were prospectively specified in the amended statistical analysis plan.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | AstraZeneca Clinical |
|---|---|
| Organization | Study Information Center |
| Phone | 1-877-240-9479 |
| information.center@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01044459
Other Study ID Numbers:
- LAS-MD-35
First Posted:
Jan 7, 2010
Last Update Posted:
Apr 20, 2017
Last Verified:
Feb 1, 2017