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Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01462942
Recruitment Status : Completed
First Posted : November 1, 2011
Results First Posted : February 15, 2017
Last Update Posted : February 15, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease (COPD)
Interventions Drug: Aclidinium Bromide/Formoterol Fumarate
Drug: Aclidinium Bromide
Drug: Placebo
Drug: Formoterol Fumarate
Enrollment 2443
Recruitment Details The study was conducted in 22 countries (Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, the Netherlands, Poland, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Sweden, Ukraine and UK). The first patient was screened in October 2011 and the last patient visit was in January 2013
Pre-assignment Details In total, 2443 patients were screened, of whom 1729 were considered eligible and were randomized into the study. 714/2443 patients were not randomized due to screening failure (primarily for non-fulfillment of inclusion/exclusion criteria)
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Period Title: Overall Study
Started 194 385 381 385 384
Completed 160 351 341 335 339
Not Completed 34 34 40 50 45
Reason Not Completed
Adverse Event             7             12             10             11             11
Other, including COPD exacerbation             3             5             2             8             5
Withdrawal by Subject             14             10             14             16             19
Lack of Efficacy             6             0             4             5             3
Lost to Follow-up             0             1             1             1             1
Protocol Violation             4             6             9             9             6
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg Total
Hide Arm/Group Description Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®) Total of all reporting groups
Overall Number of Baseline Participants 194 385 381 385 384 1729
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 194 participants 385 participants 381 participants 385 participants 384 participants 1729 participants
64.2  (8.0) 62.7  (8.1) 62.9  (7.7) 63.1  (8.2) 63.4  (7.8) 63.2  (8.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 194 participants 385 participants 381 participants 385 participants 384 participants 1729 participants
Female
56
  28.9%
124
  32.2%
122
  32.0%
129
  33.5%
129
  33.6%
560
  32.4%
Male
138
  71.1%
261
  67.8%
259
  68.0%
256
  66.5%
255
  66.4%
1169
  67.6%
1.Primary Outcome
Title Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population defined as all randomized patients who took at least one administration of study medication and had a baseline and at least one post-baseline FEV1 assessment
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Overall Number of Participants Analyzed 157 347 339 327 335
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.030  (0.018) 0.269  (0.013) 0.213  (0.013) 0.144  (0.013) 0.129  (0.013)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aclidinium/Formoterol 400/12 μg, Aclidinium 400 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.125
Confidence Interval (2-Sided) 95%
0.090 to 0.160
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aclidinium/Formoterol 400/6 μg, Aclidinium 400 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.069
Confidence Interval (2-Sided) 95%
0.034 to 0.105
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
Hide Description [Not Specified]
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Overall Number of Participants Analyzed 159 349 340 332 337
Least Squares Mean (Standard Error)
Unit of Measure: Liters
-0.061  (0.018) 0.083  (0.012) 0.050  (0.012) 0.056  (0.012) -0.002  (0.012)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Aclidinium/Formoterol 400/12 μg, Formoterol 12 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.085
Confidence Interval (2-Sided) 95%
0.051 to 0.119
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Aclidinium/Formoterol 400/6 μg, Formoterol 12 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0022
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by pre- and post-bronchodilator, age, and baseline FEV1 as covariates, and treatment group, sex, and smoking-status as fixed effect factors
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.053
Confidence Interval (2-Sided) 95%
0.019 to 0.087
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change in Transition Dyspnoea Index (TDI) Focal Score
Hide Description Evaluation of dyspnea was performed by an independent interviewer experienced in taking a respiratory history The TDI includes three categories: functional impairment which determines the impact of breathlessness on the ability to perform activities, magnitude of task which determines the type of task that caused breathlessness and magnitude of effort which establishes the level of effort needed to evoke breathlessness Each category ranges from minus three (-3; major deterioration) to plus three (+3; major improvement) including a zero (0) score to indicate 'no change' The three categories are totalled to obtain a focal score (total score) ranging from minus nine (-9), including zero (0), to plus nine (+9) Provision is made for circumstances when dyspnoea could not be rated - if reduction of activities, effort or functional impairment was caused by reasons other than respiratory A change of 1 unit in TDI is used as the criterion for a minimal meaningful improvement
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Overall Number of Participants Analyzed 156 344 333 331 333
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
1.215  (0.241) 2.508  (0.162) 2.377  (0.165) 2.112  (0.165) 2.062  (0.164)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aclidinium/Formoterol 400/12 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 1.293
Confidence Interval (2-Sided) 95%
0.728 to 1.859
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Aclidinium/Formoterol 400/6 μg
Comments Adjusted by BDI baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.162
Confidence Interval (2-Sided) 95%
0.593 to 1.730
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score
Hide Description SGRQ is a standardised, self-administered tool for measuring impaired health and perceived well-being in respiratory diseases; a validated electronic version of the questionnaire in the relevant validated languages was used in this study The questionnaire contains 50 items divided into three dimensions (Symptoms, Activity and Impact) Each of the three dimensions of the questionnaire is scored separately in the range from 0 to 100: zero (0) score indicating no impairment of quality of life The total SGRQ score ranging from 0 to 100 is a summary score utilising responses to all items calculated using weights attached to each item of the questionnaire Higher scores indicate poorer health and change of 4 units in the SGRQ has been determined to be the threshold for a clinically relevant change in health status
Time Frame Baseline and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description:
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
Overall Number of Participants Analyzed 154 338 332 327 332
Least Squares Mean (Standard Error)
Unit of Measure: Score on a scale
-6.511  (1.029) -7.164  (0.703) -8.339  (0.706) -5.801  (0.710) -5.579  (0.706)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Aclidinium/Formoterol 400/12 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5980
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.653
Confidence Interval (2-Sided) 95%
-3.082 to 1.776
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Aclidinium/Formoterol 400/6 μg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1406
Comments [Not Specified]
Method Mixed Models Analysis
Comments Adjusted by SGRQ baseline score and age as covariates, with treatment group, gender, smoking-status, visit, and group-by-visit as fixed effect factors
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -1.828
Confidence Interval (2-Sided) 95%
-4.259 to 0.604
Estimation Comments [Not Specified]
Time Frame 26 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/194 (6.19%)      23/385 (5.97%)      18/381 (4.72%)      16/385 (4.16%)      14/384 (3.65%)    
Cardiac disorders           
Atrial fibrillation  1  1/194 (0.52%)  1 0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  1/384 (0.26%)  1
Right ventricular failure  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Acute myocardial infarction  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Myocardial infarction  1  0/194 (0.00%)  2/385 (0.52%)  2 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Cardiac failure  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 1/385 (0.26%)  1 2/384 (0.52%)  2
Angina pectoris  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Acute coronary syndrome  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Cardio-respiratory arrest  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Ventricular fibrillation  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Torsade de pointes  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Congenital, familial and genetic disorders           
Diverticulitis meckel's  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Eye disorders           
Episcleritis  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Gastrointestinal disorders           
Inguinal hernia strangulated  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Pancreatitis  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Gastrointestinal haemorrhage  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Ileus  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Duodenal ulcer haemorrhage  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Gastric ulcer haemorrhage  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Hepatobiliary disorders           
Bile duct obstruction  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Cholelithiasis  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Immune system disorders           
Allergy to arthropod sting  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Allergic oedema  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Food allergy  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Infections and infestations           
Pneumonia  1  1/194 (0.52%)  1 3/385 (0.78%)  3 4/381 (1.05%)  4 0/385 (0.00%)  0/384 (0.00%) 
Lung abscess  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Infectious peritonitis  1  0/194 (0.00%)  1/385 (0.26%)  1 1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Scrotal abscess  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Pharyngeal abscess  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Cholecystitis infective  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Liver abscess  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Gastroenteritis viral  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Pulmonary tuberculosis  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Lobar pneumonia  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Infectious pleural effusion  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Tonsillitis  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Urinary tract infection  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Breast abscess  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Injury, poisoning and procedural complications           
Lumbar vertebral fracture  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Alcohol poisoning  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Brain contusion  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Concussion  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Gastrointestinal injury  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Sternal fracture  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Traumatic shock  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Femur fracture  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Laceration  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Humerus fracture  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Foot fracture  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Metabolism and nutrition disorders           
Hyperkalaemia  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Diabetes mellitus  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Prostate cancer  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Non-small cell lung cancer  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Bladder cancer  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Metastases to central nervous system  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Small cell lung cancer stage unspecified  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Bladder transitional cell carcinoma  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Pharyngeal cancer stage unspecified  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Metastatic gastric cancer  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Lung squamous cell carcinoma stage unspecified  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Lung neoplasm malignant  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Nervous system disorders           
Ischaemic stroke  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Syncope  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Cerebellar infarction  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Convulsion  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Renal and urinary disorders           
Urinary retention  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Reproductive system and breast disorders           
Benign prostatic hyperplasia  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  5/194 (2.58%)  5 4/385 (1.04%)  4 4/381 (1.05%)  4 7/385 (1.82%)  7 1/384 (0.26%)  1
Pulmonary embolism  1  0/194 (0.00%)  0/385 (0.00%)  1/381 (0.26%)  1 0/385 (0.00%)  0/384 (0.00%) 
Acute respiratory failure  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  1/384 (0.26%)  1
Skin and subcutaneous tissue disorders           
Dermatitis allergic  1  0/194 (0.00%)  1/385 (0.26%)  1 0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Vascular disorders           
Peripheral ischaemia  1  1/194 (0.52%)  1 0/385 (0.00%)  0/381 (0.00%)  0/385 (0.00%)  0/384 (0.00%) 
Deep vein thrombosis  1  0/194 (0.00%)  0/385 (0.00%)  0/381 (0.00%)  1/385 (0.26%)  1 0/384 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Aclidinium/Formoterol 400/12 μg Aclidinium/Formoterol 400/6 μg Aclidinium 400 μg Formoterol 12 μg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   42/194 (21.65%)      82/385 (21.30%)      84/381 (22.05%)      94/385 (24.42%)      105/384 (27.34%)    
Infections and infestations           
Nasopharyngitis  1  14/194 (7.22%)  30/385 (7.79%)  30/381 (7.87%)  22/385 (5.71%)  26/384 (6.77%) 
Musculoskeletal and connective tissue disorders           
Back pain  1  9/194 (4.64%)  18/385 (4.68%)  13/381 (3.41%)  20/385 (5.19%)  19/384 (4.95%) 
Nervous system disorders           
Headache  1  16/194 (8.25%)  29/385 (7.53%)  27/381 (7.09%)  35/385 (9.09%)  43/384 (11.20%) 
Respiratory, thoracic and mediastinal disorders           
Chronic obstructive pulmonary disease  1  23/194 (11.86%)  33/385 (8.57%)  36/381 (9.45%)  39/385 (10.13%)  59/384 (15.36%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication and/or presentation whether complete or partial, of any part of the data or results of this trial will not be allowed until global publication and study results disclosure by the sponsor as per EUDRACT/FDA regulatory compliance obligations, and only after mutual agreement between the investigator and sponsor
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Esther Garcia
Organization: AstraZeneca
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01462942    
Other Study ID Numbers: M/40464/30
First Submitted: October 26, 2011
First Posted: November 1, 2011
Results First Submitted: September 14, 2016
Results First Posted: February 15, 2017
Last Update Posted: February 15, 2017