Trial · NCT01966107
Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
NCT01966107, Phase 4, Completed, AstraZeneca; results first posted 2018-12-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients. Trials, record NCT01966107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01966107
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients.
- NCT number
- NCT01966107
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 3,635 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease, Moderate to Very Severe COPD
- Interventions
- Aclidinium Bromide, Placebo
- First posted
- 2013-10-21
- Last updated
- 2018-12-06
- Results first posted
- 2018-12-06
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment | 12 months | 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. |
| Primary | Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis | At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU) | 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). |
| Secondary | Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis | 12 months | 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. |
| Secondary | Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis | At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU) | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment | 12 months | 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. | Events per subject per year | NUMBER |
| SECONDARY | Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis | 12 months | 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. | Events per subject per year | NUMBER |
| SECONDARY | Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis | At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis | At Screening, Treatment period (upto 36 months) and Post-treatment follow-up (PTFU) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment | Aclidinium Bromide | 0.44 | 95% Confidence Interval 0.40 to 0.50 | Events per subject per year | |
| Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Per Subject Per Year During the First Year of Treatment | Placebo | 0.57 | 95% Confidence Interval 0.52 to 0.64 | Events per subject per year | |
| Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis | Aclidinium Bromide | 0.07 | 95% Confidence Interval 0.05 to 0.08 | Events per subject per year | |
| Rate of Hospitalizations Due to COPD Exacerbation Per Subject Per Year During the First Year of Treatment- on Treatment Analysis | Placebo | 0.10 | 95% Confidence Interval 0.08 to 0.13 | Events per subject per year | |
| Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis | Aclidinium Bromide | Number of subjects with events | 168 | Participants | |
| Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis | Placebo | Number of subjects with events | 160 | Participants | |
| Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis | Aclidinium Bromide | Number of subjects with events | 69 | Participants | |
| Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis | Placebo | Number of subjects with events | 76 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aclidinium Bromide | 1,812 | |
| Overall Study | STARTED | Placebo | 1,818 | |
| Overall Study | Full Analysis Set | Aclidinium Bromide | 1,791 | |
| Overall Study | Full Analysis Set | Placebo | 1,798 | |
| Overall Study | COMPLETED | Aclidinium Bromide | 1,010 | |
| Overall Study | COMPLETED | Placebo | 937 | |
| Overall Study | NOT COMPLETED | Aclidinium Bromide | 802 | |
| Overall Study | NOT COMPLETED | Placebo | 881 |
Source ClinicalTrials.gov
Adverse events876
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bronchitis | Infections and infestations | Aclidinium Bromide | 70 | 1,791 | 85 |
| other | Bronchitis | Infections and infestations | Placebo | 74 | 1,798 | 92 |
| other | Pneumonia | Infections and infestations | Aclidinium Bromide | 46 | 1,791 | 51 |
| other | Pneumonia | Infections and infestations | Placebo | 52 | 1,798 | 57 |
| other | Sinusitis | Infections and infestations | Aclidinium Bromide | 65 | 1,791 | 87 |
| other | Sinusitis | Infections and infestations | Placebo | 63 | 1,798 | 73 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Aclidinium Bromide | 86 | 1,791 | 104 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Placebo | 101 | 1,798 | 117 |
| other | Urinary Tract Infection | Infections and infestations | Aclidinium Bromide | 90 | 1,791 | 122 |
| other | Urinary Tract Infection | Infections and infestations | Placebo | 84 | 1,798 | 104 |
1 to 10 of 876Source ClinicalTrials.gov
See all 876 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aclidinium Bromide | 75 | 1,791 |
| Total, all-cause mortality | Placebo | 64 | 1,798 |
| Total, other adverse events | Aclidinium Bromide | 1,105 | 1,791 |
| Total, other adverse events | Placebo | 1,065 | 1,798 |
| Total, serious adverse events | Aclidinium Bromide | 409 | 1,791 |
| Total, serious adverse events | Placebo | 356 | 1,798 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Aclidinium Bromide vs Placebo: Number of Participants With Major Adverse Cardiovascular Event (MACE) - on Study Analysis | Trial comparisons |
| Aclidinium Bromide vs Placebo: Number of Participants With Major Adverse Cardiovascular Event (MACE) or Other Serious Cardiovascular Events of Interest - On-study Analysis | Trial comparisons |
| Aclidinium Bromide vs Placebo: deaths from any cause | Trial comparisons |
| Aclidinium Bromide vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01966107
GET https://conductscience.org/api/trials/v1/NCT01966107/events?page=2