A Phase 4 interventional study of Aclidinium Bromide and Placebo in COPD, Chronic Obstructive Pulmonary Disease and Moderate to Very Severe COPD, sponsored by AstraZeneca. Completed at 468 sites in 2 countries. Open to participants aged 40 Years to 130 Years. Per ClinicalTrials.gov, last updated 2018-12-06.
Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment
The Objectives of this study are to assess the safety of Aclidinium bromide on major adverse cardiovascular events (MACE), to assess the overall safety of Aclidinium bromide and to assess whether Aclidinium bromide reduces moderate or severe COPD exacerbations. This study is a double-blind, randomized, placebo controlled, parallel-group study to evaluate the effect of Aclidinium bromide on the cardiovascular safety and COPD exacerbations in patients with moderate to very severe COPD, as defined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 3,635 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.
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Must have at least one of the following 4 criteria:
At least 2 of the following atherothrombotic risk factors as determined by the PI:
Exclusion Criteria:
Two-week washout/run-in period \[for patients on a long-acting muscarinic antagonist (LAMA)\] followed by a maximum of 36-month double-blind treatment period.
Drug: Aclidinium Bromide
Two-week washout/run-in period \[for patients on a long-acting muscarinic antagonist (LAMA)\] followed by a maximum of 36-month double-blind treatment period.
Drug: Placebo
400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment
The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
Time frame: 12 months
Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis
To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis).
Time frame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis
To assess whether aclidinium bromide reduces moderate or severe COPD exacerbations. The rate of hospitalization (number of events per subject per year) due to COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline ICS use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
Time frame: 12 months
Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis
To assess the CV safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated MACE or other serious CV events of interest with treatment group, baseline CV severity, and smoking status as factors. Other serious CV events included events from Cardiac tachyarrhythmias plus preferred terms (PTs) Tachycardia, Heart rate increase, and Palpitation; Cardiac failure; Bradycardia and PTs Sinus arrest and Sinus bradycardia; Conduction defects; Conditions associated with Central nervous system haemorrhages and cerebrovascular accidents; and selected PTs included in the Other ischemic heart disease.
Time frame: At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU)
This study was conducted at 522 study centers in North America; 35 centers in Canada and 487 centers in the US. A total of 4000 subjects were planned to be enrolled. A total of 3630 subjects were randomized (1:1) to aclidinium bromide 400 μg twice a day (BID) or placebo BID. Rescue medication (albuterol/salbutamol) was provided for all subjects.
| Milestone | Aclidinium Bromide | Placebo |
|---|---|---|
| Started | 1812 | 1818 |
| Full analysis set | 1791 | 1798 |
| Completed | 1010 | 937 |
| Not completed | 802 | 881 |
| Withdrew: Excluded from fas | 21 | 20 |
| Withdrew: Discontinued treatment | 345 | 372 |
| Withdrew: Due to study closure | 164 | 186 |
| Withdrew: Withdrew from the study | 272 | 303 |
The rate (number of events per subject per year) of moderate or severe COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline inhaled corticosteroids (ICS) use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
| Events per subject per year | Aclidinium Bromide | Placebo |
|---|---|---|
| Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment | 0.44 (0.40 to 0.50) | 0.57 (0.52 to 0.64) |
To assess whether aclidinium bromide reduces moderate or severe COPD exacerbations. The rate of hospitalization (number of events per subject per year) due to COPD exacerbations during the first year of treatment based on on-treatment analysis with treatment group, baseline ICS use, baseline COPD severity, history of at least 1 exacerbation in the past year, and smoking status as factors and the log of the exposure time adjusted for the time the subjects experienced exacerbations as an offset variable.
| Events per subject per year | Aclidinium Bromide | Placebo |
|---|---|---|
| Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis | 0.07 (0.05 to 0.08) | 0.10 (0.08 to 0.13) |
To assess the CV safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated MACE or other serious CV events of interest with treatment group, baseline CV severity, and smoking status as factors. Other serious CV events included events from Cardiac tachyarrhythmias plus preferred terms (PTs) Tachycardia, Heart rate increase, and Palpitation; Cardiac failure; Bradycardia and PTs Sinus arrest and Sinus bradycardia; Conduction defects; Conditions associated with Central nervous system haemorrhages and cerebrovascular accidents; and selected PTs included in the Other ischemic heart disease.
| Participants | Aclidinium Bromide | Placebo |
|---|---|---|
| Number of subjects with events | 168 | 160 |
To assess the cardiovascular (CV) safety of aclidinium bromide on MACEs. The number of subjects with an adjudicated composite MACE with treatment group, baseline CV severity, and smoking status as factors. MACE for the analyses was defined as any adjudicated event which was a composite of the total of CV death, non-fatal myocardial infarction (MI), or non-fatal stroke (on-study analysis).
| Participants | Aclidinium Bromide | Placebo |
|---|---|---|
| Number of subjects with events | 69 | 76 |
Collected over Any adverse event occurring from the time the informed consent form was signed until 15 days after the last dose of study drug were recorded. Adverse events were collected at Visit 1A for subjects who completed a Visit 0.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aclidinium Bromide | 75/1,791 (4.2%) | 409/1,791 (22.8%) | 1,105/1,791 (61.7%) |
| Placebo | 64/1,798 (3.6%) | 356/1,798 (19.8%) | 1,065/1,798 (59.2%) |
| Event | Aclidinium Bromide | Placebo |
|---|---|---|
| PneumoniaInfections and infestations | 66/1791 | 58/1798 |
| Atrial FibrillationCardiac disorders | 24/1791 | 17/1798 |
| Coronary Artery DiseaseCardiac disorders | 21/1791 | 8/1798 |
| Cardiac Failure CongestiveCardiac disorders | 21/1791 | 18/1798 |
| Non-Cardiac Chest PainGeneral disorders | 17/1791 | 8/1798 |
| Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders | 16/1791 | 17/1798 |
| CellulitisInfections and infestations | 14/1791 | 10/1798 |
| Acute Myocardial InfarctionCardiac disorders | 14/1791 | 12/1798 |
| SepsisInfections and infestations | 12/1791 | 14/1798 |
| Myocardial InfarctionCardiac disorders | 10/1791 | 13/1798 |
| Event | Aclidinium Bromide | Placebo |
|---|---|---|
| Upper Respiratory Tract InfectionInfections and infestations | 86/1791 | 101/1798 |
| Urinary Tract InfectionInfections and infestations | 90/1791 | 84/1798 |
| Viral Upper Respiratory Tract InfectionInfections and infestations | 78/1791 | 67/1798 |
| NauseaGastrointestinal disorders | 77/1791 | 57/1798 |
| BronchitisInfections and infestations | 70/1791 | 74/1798 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 48/1791 | 70/1798 |
| Back PainMusculoskeletal and connective tissue disorders | 69/1791 | 54/1798 |
| CoughRespiratory, thoracic and mediastinal disorders | 67/1791 | 62/1798 |
| SinusitisInfections and infestations | 65/1791 | 63/1798 |
| HeadacheNervous system disorders | 57/1791 | 65/1798 |
The Full Analysis Set (FAS) population consisted of all subjects in the Randomized Population who took at least one dose of the double-blind IP (aclidinium bromide or placebo). Subjects were analyzed according to their randomized treatment.
| Age, Continuous(Years) | Aclidinium Bromide | Placebo | Total |
|---|---|---|---|
| Mean | 67.1 ± 8.5 | 67.2 ± 8.3 | 67.2 ± 8.4 |
| Age, Customized(Participants) | Aclidinium Bromide | Placebo | Total |
|---|---|---|---|
| >=40 - <60 years | 340 | 325 | 665 |
| >=60 - <70 years | 724 | 725 | 1449 |
| >=70 years | 727 | 748 | 1475 |
| Sex: Female, Male(Participants) | Aclidinium Bromide | Placebo | Total |
|---|---|---|---|
| Female | 732 | 752 | 1484 |
| Male | 1059 | 1046 | 2105 |
| Race/Ethnicity, Customized(Participants) | Aclidinium Bromide | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 5 | 4 | 9 |
| Asian | 8 | 4 | 12 |
| Native Hawaiian or Other Pacific Islander | 3 | 0 | 3 |
| Black or African American | 165 | 138 | 303 |
| White | 1603 | 1650 | 3253 |
| Other | 7 | 2 | 9 |
Showing the first 100 of 468 sites across 2 countries.
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