An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by AstraZeneca. Completed at 1 site in United Kingdom. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by AstraZeneca · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 5th largest by enrollment of the 89 observational ones that give a count, is one of 14 that started in 2017, is one of 90 observational ones, and was the 208th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in France
Ages 18–99
AstraZeneca · Sites in India
Ages 18+
AstraZeneca · Sites in Argentina, Egypt, Mexico and 4 more countries
Ages 18+
AstraZeneca · Sites in Argentina, Colombia, Egypt and 9 more countries
Ages 30–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
284 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 57 · Phase 3 77 · Phase 4 19
First in 1999; this study’s year is marked. 14 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 26,839 is above the median of 159 across 1,498 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 137 across the 194 interventional studies, 976 across the 89 observational. Of the 264 that completed or were terminated, 127 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
9 of the studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07245576AstraZenecaAssess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis | 2027-04-30 |
| NCT07315958AstraZenecaStudy for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics | 2027-04-30 |
| NCT07073950AstraZenecaA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation | 2027-05-31 |
| NCT07307781AstraZenecaStudy of Patient With Frequent Exacerbations in Moscow | 2027-06-25 |
Add all 9 to your calendar (.ics) → With an account.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the potential cardiovascular safety concerns and all-cause mortality described in the risk management plan for aclidinium bromide, through sequential, nested case-control studies for each endpoint of interest
This is a post-authorisation safety study (PASS) of new users of aclidinium bromide, fixed dose aclidinium bromide/formoterol fumarate dihydrate, and other inhaled medications frequently used by patients with COPD
The plan is for the PASS study to be conducted on one population-based automated health database; the initial candidate database is the CRPD in the United Kingdom.
The study will be conducted in patients aged 40 years or older diagnosed with COPD initiating treatment with aclidinium bromide or other inhaled COPD treatments. Patients must have at least 1 year of enrolment in the electronic database and to have not been prescribed the study medication of interest during the 6-months before the date of the first prescription for that specific study medication. Patients with life-threatening non-cardiovascular comorbidity (e.g., malignancy, HIV infection, other) will be excluded
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This nested cohort will be composed of patients aged 40 years or older who have previously been diagnosed with COPD and who are new users of aclidinium bromide (monotherapy; concomitant with formoterol not in fixed-dose combination; and aclidinium/formoterol)
Drug: Aclidinium bromide
This nested cohort will include patients aged 40 years or older who have previously been diagnosed with COPD and who are new users of other COPD medication: tiotropium, other LAMAs, LABA, LABA/ICS and LAMA/LABA.
Drug: Other COPD medication
Administered as monotherapy, concomitant with formoterol not in fixed-dose combination, or fixed-dose aclidinium/formoterol
Users of the following COPD medications: Tiotropium Other long-acting anticholinergic (LAMAs): glycopyrronium bromide, umeclidinium LABA: formoterol, salmeterol, indacaterol LABA/ICS (LABA in fixed-dose combinations with ICS): formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone, and vilanterol/fluticasone. LAMA/LABA (approved or under regulatory review or in development): glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol
Incidence rate of mortality from all causes
Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [January 2017]).
Incidence rate of first-ever hospitalisation for heart failure
Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [First semester 2017]).
Incidence rate of hospitalisation for acute myocardial infarction (fatal or non-fatal)
Including community (out-of-hospital) coronary heart disease deaths. Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [First semester 2021]).
Incidence rate of acute stroke (fatal or non-fatal)
Including community (out-of-hospital) cerebrovascular disease deaths. Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [First semester 2020]).
Incidence rate of new episodes of any type of diagnosed cardiac arrhythmia
Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [First semester 2022]).
Relative risk of acute myocardial infarction, stroke, and out-of-hospital coronary heart disease or cerebrovascular death
A composite endpoint of acute myocardial infarction, stroke, and out-of-hospital coronary heart disease or cerebrovascular death (if confirmed that the direction and magnitude of the risk is similar across the individual components). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period of individual components (2-3 months following start of data collection).
Incidence rate of new episodes of atrial fibrillation or flutter
Including episodes of paroxysmal (intermittent) atrial fibrillation or a new episode (first ever) or atrial fibrillation in patients without atrial fibrillation or flutter. Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [First semester 2022]).
Incidence rate of new episodes of serious ventricular arrhythmias (SVA)
Age- and sex-standardised incidence rate per 1,000 person-years (95% CI). Potential cases will be identified by general practitioner diagnosis, hospital discharge codes and mortality data from national statistics.
Time frame: From the launch of Aclidinium Bromide in the UK (October 2012) to the end of the study period (2-3 months following start of data collection [First semester 2022]).
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in Jun 2022, 63 months.
Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's 63 months is above that.
Counting every sponsor, half of 587 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pulmonary Disease, Chronic Obstructive →