An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by AstraZeneca. Completed at 3 sites in 3 countries. Per ClinicalTrials.gov, last updated 2018-02-22.
Sponsored by AstraZeneca · Observational
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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 7th largest by enrollment of the 89 observational ones that give a count, is one of 19 that started in 2015, is one of 90 observational ones, and was the 210th 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: 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. 19 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 22,155 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.
DUS1 and DUS2 are descriptive drug utilisation studies in new users of aclidinium bromide in Europe.
The objectives of DUS1 and DUS2 are to describe the characteristics and patterns of use of new users of aclidinium bromide (monotherapy or in combination) and new users of other medications for chronic obstructive pulmonary disease (COPD); to evaluate the potential off-label use of aclidinium bromide; to describe users of aclidinium bromide in subgroups of patients for whom there is missing information in the risk management plan (RMP); and to establish a core cohort of new users of aclidinium bromide for the future evaluation of safety concerns described in the RMP.
The data source for these studies will be the CRPD in the UK, the GePaRD in Germany, and national health databases in Denmark.
DUS1 will be conducted when the target number of new users of aclidinium monotherapy is reached, and DUS2 when the target number of new users of aclidinium fixed-dose combination with formoterol is reached.
As this was a descriptive study no primary or secondary endpoints were specified.
New users of aclidinium bromide (on monotherapy or with concomitant use of formoterol) and new users of other COPD medications will be identified and included in the specific exposure cohort of interest.
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.
The same inclusion criteria will be applied for each of the comparator drugs.
Exclusion Criteria:
In DUS1, all new users of aclidinium either on monotherapy or with concomitant formoterol will be included. In addition, in DUS2, all new users of the fixed-dose combination of aclidinium/formoterol and any other new fixed-dose combinations of LAMAs and LABAs that become available during the study and that are captured in each database will be included.
Drug: Aclidinium bromide
In DUS1, all new users of aclidinium either on monotherapy or with concomitant formoterol will be included. In addition, in DUS2, all new users of the fixed-dose combination of aclidinium/formoterol and any other new fixed-dose combinations of LAMAs and LABAs that become available during the study and that are captured in each database will be included.
Drug: Aclidinium bromide/formoterol
New users of other COPD medications (tiotropium, other LAMAs, LABA, LABA/ICS, LAMA/LABA), prescribed as recorded in the database.
Drug: Other COPD medication
Administered as monotherapy, prescribed as recorded in the database.
Drug pages: Aclidinium bromide · Formoterol
Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.
Other COPD medication including: tiotropium; other long-acting anticholinergic (LAMAs; lycopyrronium bromide, umeclidinium); LABA (formoterol, salmeterol, indacaterol); LABA/ICS (formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone propionate, and vilanterol/fluticasone); LAMA/LABA (approved or under regulatory review or in development; glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol), prescribed as recorded in the database.
Baseline age of new users
Time frame: Baseline (date of first prescription)
Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis
Time frame: Baseline (date of first prescription)
Baseline frequency of new users with severe COPD
COPD severity including recent exacerbations
Time frame: Baseline (date of first prescription)
Baseline frequency of new users with a history of cardiovascular disease
Baseline history of cardiovascular diseases and baseline cardiovascular risk profile, including diabetes, recent acute myocardial infarction (AMI), unstable angina, arrhythmias, or heart failure
Time frame: Baseline (date of first prescription)
Overall comorbidity index of new users
Time frame: From date of first prescription up to 1 year of follow-up
Frequency of respiratory medication use by new users
Time frame: From date of first prescription to 1 year of follow-up
Baseline gender of new users
Time frame: Baseline (date of first prescription)
Frequency of users of aclidinium bromide with comorbid asthma diagnoses or in the absence of other drugs or diagnoses suggestive of COPD
Time frame: From date of first prescription up to 1 year of follow-up
Frequency of pregnancies during use of COPD medication
Time frame: From date of first prescription up to 1 year of follow-up
Frequency of use of aclidinium bromide in the pediatric population
Time frame: From date of first prescription up to 1 year of follow-up
Frequency of comorbid conditions in the paediatric population
Time frame: From date of first prescription up to 1 year of follow-up
Baseline frequency of patients with renal or hepatic impairment
Time frame: Baseline (date of first prescription)
Baseline frequency of patients who have experienced a recent exacerbation
Time frame: Baseline (date of first prescription
Baseline frequency of patients with thyrotoxicosis or pheochromocytoma
Time frame: Baseline (date of first prescription)
Frequency of previous smoking in new users
Time frame: From date of first prescription to 1 year of follow-up
Frequency of current smokers in new users
Time frame: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI <18.50 kg/m2 (underweight)
Time frame: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI ranging from 18.50 to 24.99 kg/m2 (normal weight)
Time frame: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI >25.0 kg/m2 (overweight)
Time frame: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI ranging between 25.0 and 29.99 kg/m2 (pre-obese)
Time frame: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI >30 kg/m2 (obese)
Time frame: From date of first prescription to 1 year of follow-up
Frequency of new users with low socioeconomic status (Townsend multiple deprivation index)
Time frame: From date of first prescription to 1 year of follow-up
Baseline frequency of patients with benign prostatic hyperplasia
Time frame: Baseline (date of first prescription)
Baseline frequency of patients with bladder neck obstruction
Time frame: Baseline (date of first prescription)
Baseline frequency of patients with urinary retention
Time frame: Baseline (date of first prescription)
Baseline frequency of patients with narrow-angle glaucoma
Time frame: Baseline (date of first prescription)
Duration of COPD medication use
Duration of use will be estimated through the number of consecutive prescriptions, with a maximum interval of 60 days between them, or the days of supply of each prescription, as available in each database.
Time frame: From date of first prescription up to 1 year of follow-up
Average daily dose of COPD medication
The daily dose for each treatment will be derived from the recorded dose or from the time between consecutive prescriptions and prescribing information (strength, number of units, and number of boxes) according to the available information in each database.
Time frame: From date of first prescription up to 1 year of follow-up
Adherence to COPD medication within 1 year
Consecutive prescriptions are defined as those with a maximum gap of 60 days between the date of prescriptions. Proportion of patients refilling prescriptions within 60 days from the end of the previous prescription.
Time frame: From date of first prescription up to 1 year of follow-up
Frequency of use of concomitant medications
Time frame: From date of first prescription up to 1 year of follow-up
Frequency of switching between COPD medications
Time frame: From date of first prescription up to 1 year of follow-up
Total number of prescriptions
Time frame: From date of first prescription up to 1 year of follow-up
Ran from Jul 2015 to primary completion in Feb 2017, 19 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 19 months is close to 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 Feb 2018. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →