Trial Outcomes & Findings for Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT01437540)
NCT ID: NCT01437540
Last Updated: 2017-05-11
Results Overview
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
590 participants
Primary outcome timeframe
Up to study Week 56 ± 3 days
Results posted on
2017-05-11
Participant Flow
The study was conducted at 127 centers in the United States The first patient was screened in September 2011 and the last patient visit was in March 2013
The study consisted of a 2- to 3-week run-in period designed to assess the stability of patients' disease and establish each patient's baseline characteristics 1063 patients were screened for eligibility; 473 were considered screen failures (main reason \[406/473\] inclusion/exclusion criteria not met)
Participant milestones
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Overall Study
STARTED
|
392
|
198
|
|
Overall Study
COMPLETED
|
265
|
133
|
|
Overall Study
NOT COMPLETED
|
127
|
65
|
Reasons for withdrawal
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Overall Study
Not listed below
|
7
|
6
|
|
Overall Study
COPD exacerbation
|
13
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
23
|
11
|
|
Overall Study
Protocol Violation
|
24
|
12
|
|
Overall Study
Adverse Event
|
26
|
13
|
|
Overall Study
Withdrawal by Subject
|
31
|
15
|
Baseline Characteristics
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=392 Participants
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=198 Participants
Formoterol 12 μg administered BID via dry-powder inhaler
|
Total
n=590 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 Years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
64.7 Years
STANDARD_DEVIATION 9.4 • n=7 Participants
|
64.2 Years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
176 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
265 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
216 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
325 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to study Week 56 ± 3 daysPopulation: Safety Population defined as all randomized patients who took at least one dose of double-blind investigational product
TEAEs were coded Version 16.0 of the Medical Dictionary for Regulatory Activities (MedDRA)
Outcome measures
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=392 Participants
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=198 Participants
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Percentage of Patients to Experience at Least One Treatment-emergent Adverse Event (TEAE)
|
71.4 Percentage of participants
|
65.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to study Week 52Population: Patients with available non-potentially clinically significant baseline value and at least one post-baseline assessment
\<0.85 x lower limit of normal (LLN) or \> 1.15 upper limit of normal (ULN) for hemoglobin, hematocrit, red blood cell, platelet, white blood cell, neutrophil and lymphocyte counts \>1.15 × ULN for eosinophil, basophil and monocyte counts \>1.15 x ULN for aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, total bilirubin, creatinine kinase, lactate dehydrogenase, blood urea nitrogen, creatinine, uric acid, total cholesterol, triglycerides \<0.85 x LLN or \>1.15 ULN for fasting glucose, calcium, phosphorus, total protein and albumin \<0.95 x LLN or \>1.05 x ULN for sodium, potassium and chloride Urinary blood, ketones or pH \<0.85 x LLN or \> 1.15 ULN
Outcome measures
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=380 Participants
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=195 Participants
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Percentage of Patients to Experience Any Potentially Clinically Significant (PCS) Post-baseline Change in Clinical Laboratory Values for Hematology, Chemistry or Urinalysis at the End of the Study
|
63.9 Percentage of participants
|
62.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to study Week 56 ± 3 daysPopulation: Patients with baseline and at least 1 post-baseline assessment of vital signs for each parameter
Systolic BP ≥180 mmHg and increase ≥20 mmHg from baseline or ≤90 mmHg and decrease ≥20 mmHg from baseline; Diastolic BP ≥105 mmHg and increase ≥15 mmHg from baseline or ≤50 mmHg and decrease ≥15 mmHg from baseline; Pulse rate ≥ 110 bpm and increase ≥ 15% from baseline or ≤ 50 bpm and decrease ≥15% from baseline
Outcome measures
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=389 Participants
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=198 Participants
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Diastolic BP ≥105 mmHg and increase ≥15 mmHg
|
0 Percentage of patients
|
0.5 Percentage of patients
|
|
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Diastolic BP ≤50 mmHg and decrease ≥15 mmHg
|
0.3 Percentage of patients
|
1.0 Percentage of patients
|
|
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Pulse rate ≥ 110 bpm and increase ≥ 15%
|
0.8 Percentage of patients
|
0.5 Percentage of patients
|
|
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Pulse rate ≤ 50 bpm and decrease ≥15%
|
0 Percentage of patients
|
0 Percentage of patients
|
|
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Systolic BP ≥180 mmHg and increase ≥20 mmHg
|
0.3 Percentage of patients
|
0.5 Percentage of patients
|
|
Percentage of Patients to Experience a Potentially Clinically Significant (PCS) Change in Pulse Rate, Systolic and Diastolic Blood Pressure
Systolic BP ≤90 mmHg and decrease ≥20 mmHg
|
1.5 Percentage of patients
|
1.0 Percentage of patients
|
SECONDARY outcome
Timeframe: Up to study Week 56 ± 3 daysPopulation: Patients with baseline and at least 1 post-baseline assessment value for each parameter
Potentially clinically significant changes were defined as listed in the table below for QT interval, QTcB, QTcF, QRS interval, PR interval and heart rate (HR)
Outcome measures
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=392 Participants
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=198 Participants
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QT interval change from baseline >30 msec
|
42.0 Percentage of patients
|
44.7 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QT interval >480 msec
|
3.9 Percentage of patients
|
2.0 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QTcB change from baseline >30 msec
|
31.1 Percentage of patients
|
30.3 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QTcB value >480 msec
|
3.1 Percentage of patients
|
4.5 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QTcF change from baseline >30 msec
|
21.5 Percentage of patients
|
22.7 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QTcF value >480 msec
|
1.5 Percentage of patients
|
1.5 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
QRS interval ≥100 msec and increase ≥25% from base
|
2.0 Percentage of patients
|
1.0 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
PR interval ≥200 msec and increase ≥25% from base
|
2.8 Percentage of patients
|
1.0 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
HR ≥110 bpm and decrease ≥15% from baseline
|
2.6 Percentage of patients
|
1.0 Percentage of patients
|
|
Percentage of Patients to Experience Potentially Clinically Significant Changes in ECG From Baseline
HR ≤50 bpm and decrease ≥15% from baseline
|
4.6 Percentage of patients
|
4.0 Percentage of patients
|
Adverse Events
Aclidinium/Formoterol 400 μg/12 μg
Serious events: 38 serious events
Other events: 164 other events
Deaths: 0 deaths
Formoterol 12 μg
Serious events: 21 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=392 participants at risk
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=198 participants at risk
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.0%
4/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.51%
2/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.51%
2/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
General disorders
Death
|
0.51%
2/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
General disorders
Non-cardiac chest pain
|
0.51%
2/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Abscess intestinal
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Angina pectoris
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Atrial flutter
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Carotid artery disease
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Cellulitis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Psychiatric disorders
Completed suicide
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Coronary artery occlusion
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Reproductive system and breast disorders
Cystocele
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Diverticulitis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Headache
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Blood and lymphatic system disorders
Hilar lymphadenopathy
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Vascular disorders
Hypertension
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Lobar pneumonia
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage III
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Melaena
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Vascular disorders
Peripheral vascular disorder
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Reproductive system and breast disorders
Rectocele
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Immune system disorders
Sarcoidosis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Syncope
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Urinary tract infection
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.26%
1/392 • Up to study Week 56 ± 3 days
|
0.00%
0/198 • Up to study Week 56 ± 3 days
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Brain mass
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Renal and urinary disorders
Calculus ureteric
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Liver abscess
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
|
Eye disorders
Vision blurred
|
0.00%
0/392 • Up to study Week 56 ± 3 days
|
0.51%
1/198 • Up to study Week 56 ± 3 days
|
Other adverse events
| Measure |
Aclidinium/Formoterol 400 μg/12 μg
n=392 participants at risk
Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
|
Formoterol 12 μg
n=198 participants at risk
Formoterol 12 μg administered BID via dry-powder inhaler
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
1.8%
7/392 • Up to study Week 56 ± 3 days
|
5.6%
11/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
25/392 • Up to study Week 56 ± 3 days
|
4.5%
9/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Sinusitis
|
5.1%
20/392 • Up to study Week 56 ± 3 days
|
5.6%
11/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
18/392 • Up to study Week 56 ± 3 days
|
6.1%
12/198 • Up to study Week 56 ± 3 days
|
|
Infections and infestations
Urinary tract infection
|
6.6%
26/392 • Up to study Week 56 ± 3 days
|
5.6%
11/198 • Up to study Week 56 ± 3 days
|
|
Psychiatric disorders
Anxiety
|
5.9%
23/392 • Up to study Week 56 ± 3 days
|
2.5%
5/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.6%
10/392 • Up to study Week 56 ± 3 days
|
5.1%
10/198 • Up to study Week 56 ± 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
27.0%
106/392 • Up to study Week 56 ± 3 days
|
28.8%
57/198 • Up to study Week 56 ± 3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results by the principal investigator (PI) will be subject to mutual agreement between the PI and sponsor
- Publication restrictions are in place
Restriction type: OTHER