Trial Outcomes & Findings for Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination (NCT NCT01462942)
NCT ID: NCT01462942
Last Updated: 2017-02-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2443 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2017-02-15
Participant Flow
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
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)
Participant milestones
| Measure |
Placebo
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
194
|
385
|
381
|
385
|
384
|
|
Overall Study
COMPLETED
|
160
|
351
|
341
|
335
|
339
|
|
Overall Study
NOT COMPLETED
|
34
|
34
|
40
|
50
|
45
|
Reasons for withdrawal
| Measure |
Placebo
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
7
|
12
|
10
|
11
|
11
|
|
Overall Study
Other, including COPD exacerbation
|
3
|
5
|
2
|
8
|
5
|
|
Overall Study
Withdrawal by Subject
|
14
|
10
|
14
|
16
|
19
|
|
Overall Study
Lack of Efficacy
|
6
|
0
|
4
|
5
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
1
|
1
|
|
Overall Study
Protocol Violation
|
4
|
6
|
9
|
9
|
6
|
Baseline Characteristics
Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination
Baseline characteristics by cohort
| Measure |
Placebo
n=194 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
n=385 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
n=381 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
n=385 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
n=384 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Total
n=1729 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.2 Years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
62.7 Years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
62.9 Years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
63.1 Years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
63.4 Years
STANDARD_DEVIATION 7.8 • n=21 Participants
|
63.2 Years
STANDARD_DEVIATION 8.0 • n=10 Participants
|
|
Gender
Female
|
56 Participants
n=5 Participants
|
124 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
560 Participants
n=10 Participants
|
|
Gender
Male
|
138 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
256 Participants
n=4 Participants
|
255 Participants
n=21 Participants
|
1169 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: 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
Outcome measures
| Measure |
Placebo
n=157 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
n=347 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
n=339 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
n=327 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
n=335 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
|---|---|---|---|---|---|
|
Change From Baseline in 1-hour Morning Post-dose Forced Expiratory Volume in One Second (FEV1)
|
-0.030 Liters
Standard Error 0.018
|
0.269 Liters
Standard Error 0.013
|
0.213 Liters
Standard Error 0.013
|
0.144 Liters
Standard Error 0.013
|
0.129 Liters
Standard Error 0.013
|
PRIMARY outcome
Timeframe: Baseline and Week 24Outcome measures
| Measure |
Placebo
n=159 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
n=349 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
n=340 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
n=332 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
n=337 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
|---|---|---|---|---|---|
|
Change From Baseline in Morning Pre-dose (Trough) Forced Expiratory Volume in One Second (FEV1)
|
-0.061 Liters
Standard Error 0.018
|
0.083 Liters
Standard Error 0.012
|
0.050 Liters
Standard Error 0.012
|
0.056 Liters
Standard Error 0.012
|
-0.002 Liters
Standard Error 0.012
|
SECONDARY outcome
Timeframe: Baseline and Week 24Evaluation 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
Outcome measures
| Measure |
Placebo
n=156 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
n=344 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
n=333 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
n=331 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
n=333 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
|---|---|---|---|---|---|
|
Change in Transition Dyspnoea Index (TDI) Focal Score
|
1.215 Score on a scale
Standard Error 0.241
|
2.508 Score on a scale
Standard Error 0.162
|
2.377 Score on a scale
Standard Error 0.165
|
2.112 Score on a scale
Standard Error 0.165
|
2.062 Score on a scale
Standard Error 0.164
|
SECONDARY outcome
Timeframe: Baseline and Week 24SGRQ 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
Outcome measures
| Measure |
Placebo
n=154 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/12 μg
n=338 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium/Formoterol 400/6 μg
n=332 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Aclidinium 400 μg
n=327 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
Formoterol 12 μg
n=332 Participants
Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
|
|---|---|---|---|---|---|
|
Change From Baseline in St. George´s Respiratory Questionnaire (SGRQ) Total Score
|
-6.511 Score on a scale
Standard Error 1.029
|
-7.164 Score on a scale
Standard Error 0.703
|
-8.339 Score on a scale
Standard Error 0.706
|
-5.801 Score on a scale
Standard Error 0.710
|
-5.579 Score on a scale
Standard Error 0.706
|
Adverse Events
Placebo
Serious events: 12 serious events
Other events: 42 other events
Deaths: 0 deaths
Aclidinium/Formoterol 400/12 μg
Serious events: 23 serious events
Other events: 82 other events
Deaths: 0 deaths
Aclidinium/Formoterol 400/6 μg
Serious events: 18 serious events
Other events: 84 other events
Deaths: 0 deaths
Aclidinium 400 μg
Serious events: 16 serious events
Other events: 94 other events
Deaths: 0 deaths
Formoterol 12 μg
Serious events: 14 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=194 participants at risk
|
Aclidinium/Formoterol 400/12 μg
n=385 participants at risk
|
Aclidinium/Formoterol 400/6 μg
n=381 participants at risk
|
Aclidinium 400 μg
n=385 participants at risk
|
Formoterol 12 μg
n=384 participants at risk
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Nervous system disorders
Ischaemic stroke
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Immune system disorders
Allergy to arthropod sting
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Vascular disorders
Peripheral ischaemia
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Pneumonia
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.78%
3/385 • Number of events 3 • 26 Weeks
|
1.0%
4/381 • Number of events 4 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Lung abscess
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Cardiac disorders
Right ventricular failure
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.6%
5/194 • Number of events 5 • 26 Weeks
|
1.0%
4/385 • Number of events 4 • 26 Weeks
|
1.0%
4/381 • Number of events 4 • 26 Weeks
|
1.8%
7/385 • Number of events 7 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.52%
1/194 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Congenital, familial and genetic disorders
Diverticulitis meckel's
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/194 • 26 Weeks
|
0.52%
2/385 • Number of events 2 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Infectious peritonitis
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Immune system disorders
Allergic oedema
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.00%
0/194 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Immune system disorders
Food allergy
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.52%
2/384 • Number of events 2 • 26 Weeks
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Liver abscess
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/381 • Number of events 1 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Nervous system disorders
Convulsion
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Eye disorders
Episcleritis
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.26%
1/385 • Number of events 1 • 26 Weeks
|
0.00%
0/384 • 26 Weeks
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Cardiac disorders
Torsade de pointes
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Infections and infestations
Breast abscess
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/194 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.00%
0/381 • 26 Weeks
|
0.00%
0/385 • 26 Weeks
|
0.26%
1/384 • Number of events 1 • 26 Weeks
|
Other adverse events
| Measure |
Placebo
n=194 participants at risk
|
Aclidinium/Formoterol 400/12 μg
n=385 participants at risk
|
Aclidinium/Formoterol 400/6 μg
n=381 participants at risk
|
Aclidinium 400 μg
n=385 participants at risk
|
Formoterol 12 μg
n=384 participants at risk
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
11.9%
23/194 • 26 Weeks
|
8.6%
33/385 • 26 Weeks
|
9.4%
36/381 • 26 Weeks
|
10.1%
39/385 • 26 Weeks
|
15.4%
59/384 • 26 Weeks
|
|
Nervous system disorders
Headache
|
8.2%
16/194 • 26 Weeks
|
7.5%
29/385 • 26 Weeks
|
7.1%
27/381 • 26 Weeks
|
9.1%
35/385 • 26 Weeks
|
11.2%
43/384 • 26 Weeks
|
|
Infections and infestations
Nasopharyngitis
|
7.2%
14/194 • 26 Weeks
|
7.8%
30/385 • 26 Weeks
|
7.9%
30/381 • 26 Weeks
|
5.7%
22/385 • 26 Weeks
|
6.8%
26/384 • 26 Weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
9/194 • 26 Weeks
|
4.7%
18/385 • 26 Weeks
|
3.4%
13/381 • 26 Weeks
|
5.2%
20/385 • 26 Weeks
|
4.9%
19/384 • 26 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER