Pulmonary Disease, Chronic ObstructiveDUS1/DUS2NCT03333018
A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 3 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Aclidinium bromide, Aclidinium bromide/formoterol and Other COPD medication
- How many people
- 22,155 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 6 Jul 2015to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- Patients in the study will be required to meet the following criteria, as ascertained from each of the automated databases:
- To have at least 1 year of enrolment in the database (DUS1 and DUS2).
- To have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS1
- To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS2
- The same inclusion criteria will be applied for each of the comparator drugs.
Who cannot join
- No age restrictions or exclusion criteria will be applied. This will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. Identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this DUS.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Denmark1 site
National Health Database Denmark, Southern Denmark University
Odense
About this study
Official title: Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
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.
Read the detailed description
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Aclidinium bromide, Aclidinium bromide/formoterol, Other COPD medication
- Keywords
- COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aclidinium bromideDrug
Administered as monotherapy, prescribed as recorded in the database.
Aclidinium bromide/formoterolDrug
Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.
Other COPD medicationDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Aclidinium bromide monotherapy | 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. Receives: Drug: Aclidinium bromide | |
| Aclidinium bromide and formoterol | 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. Receives: Drug: Aclidinium bromide/formoterol | |
| New users of other COPD medication | New users of other COPD medications (tiotropium, other LAMAs, LABA, LABA/ICS, LAMA/LABA), prescribed as recorded in the database. Receives: Drug: Other COPD medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline age of new users
Measured: Baseline (date of first prescription)
Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis
Measured: Baseline (date of first prescription)
Baseline frequency of new users with severe COPD
COPD severity including recent exacerbations
Measured: 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
Measured: Baseline (date of first prescription)
Overall comorbidity index of new users
Measured: From date of first prescription up to 1 year of follow-up
Frequency of respiratory medication use by new users
Measured: From date of first prescription to 1 year of follow-up
Baseline gender of new users
Measured: 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
Measured: From date of first prescription up to 1 year of follow-up
Frequency of pregnancies during use of COPD medication
Measured: From date of first prescription up to 1 year of follow-up
Frequency of use of aclidinium bromide in the pediatric population
Measured: From date of first prescription up to 1 year of follow-up
Frequency of comorbid conditions in the paediatric population
Measured: From date of first prescription up to 1 year of follow-up
Baseline frequency of patients with renal or hepatic impairment
Measured: Baseline (date of first prescription)
Baseline frequency of patients who have experienced a recent exacerbation
Measured: Baseline (date of first prescription
Baseline frequency of patients with thyrotoxicosis or pheochromocytoma
Measured: Baseline (date of first prescription)
Frequency of previous smoking in new users
Measured: From date of first prescription to 1 year of follow-up
Frequency of current smokers in new users
Measured: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI <18.50 kg/m2 (underweight)
Measured: 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)
Measured: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI >25.0 kg/m2 (overweight)
Measured: 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)
Measured: From date of first prescription to 1 year of follow-up
Frequency of new users with BMI >30 kg/m2 (obese)
Measured: From date of first prescription to 1 year of follow-up
Frequency of new users with low socioeconomic status (Townsend multiple deprivation index)
Measured: From date of first prescription to 1 year of follow-up
Baseline frequency of patients with benign prostatic hyperplasia
Measured: Baseline (date of first prescription)
Baseline frequency of patients with bladder neck obstruction
Measured: Baseline (date of first prescription)
Baseline frequency of patients with urinary retention
Measured: Baseline (date of first prescription)
Baseline frequency of patients with narrow-angle glaucoma
Measured: Baseline (date of first prescription)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: From date of first prescription up to 1 year of follow-up
Frequency of use of concomitant medications
Measured: From date of first prescription up to 1 year of follow-up
Frequency of switching between COPD medications
Measured: From date of first prescription up to 1 year of follow-up
Total number of prescriptions
Measured: From date of first prescription up to 1 year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start6 Jul 2015
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 22,155 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Jordi Castellsague, MD, MPH, Study director, RTI Health SolutionsSusana Perez-Gutthann, MD, PhD, Study director, RTI Health Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333018
- Sponsor's protocol ID
- D6560R00005
- Other IDs
- EUPAS6559
- Acronym
- DUS1/DUS2
- Status last verified
- Feb 2018
- First submitted
- 6 Oct 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
- ClinicalTrials.gov ID
- NCT03333018
- Acronym / sponsor ID
- DUS1/DUS2 / D6560R00005
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22,155 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aclidinium bromide monotherapy | – | Drug: Aclidinium bromideIn 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. |
| Aclidinium bromide and formoterol | – | Drug: Aclidinium bromide/formoterolIn 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. |
| New users of other COPD medication | – | Drug: Other COPD medicationNew users of other COPD medications (tiotropium, other LAMAs, LABA, LABA/ICS, LAMA/LABA), prescribed as recorded in the database. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Patients in the study will be required to meet the following criteria, as ascertained from each of the automated databases:
- To have at least 1 year of enrolment in the database (DUS1 and DUS2).
- To have not been prescribed aclidinium bromide as monotherapy or with concomitant use of formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS1
- To have not been prescribed aclidinium bromide as monotherapy, with concomitant use of formoterol, or as aclidinium/formoterol during the 6 months before the date of first prescription of aclidinium bromide (index date) in DUS2
- The same inclusion criteria will be applied for each of the comparator drugs.
Key exclusion criteria (1 listed)
- No age restrictions or exclusion criteria will be applied. This will allow for the characterisation of all users of aclidinium bromide and comparator drugs irrespective of the indication for which these medications are used. Identification of potential off-label use of aclidinium bromide in the paediatric and adult populations is one of the specific objectives of this DUS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aclidinium bromideAdministered as monotherapy, prescribed as recorded in the database. | Drug | Aclidinium bromide monotherapy |
| Aclidinium bromide/formoterolAdministered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database. | Drug | Aclidinium bromide and formoterol |
| Other COPD medicationOther 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. | Drug | New users of other COPD medication |
Primary outcome
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
Time frame: Baseline (date of first prescription)
COPD severity including recent exacerbations
Baseline frequency of new users with a history of cardiovascular disease
Time frame: Baseline (date of first prescription)
Baseline history of cardiovascular diseases and baseline cardiovascular risk profile, including diabetes, recent acute myocardial infarction (AMI), unstable angina, arrhythmias, or heart failure
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)
6 secondary outcomes
Duration of COPD medication use
Time frame: From date of first prescription up to 1 year of follow-up
Average daily dose of COPD medication
Time frame: From date of first prescription up to 1 year of follow-up
Adherence to COPD medication within 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- CSR SynopsisLink provided by the sponsor.
Related trials for Pulmonary Disease, Chronic Obstructive
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
Not yet recruiting
Impact of Multidisciplinary Care, Structured and Targeted on the COPD Patient's Clinical Pathway.
Chronic Obstructive Pulmonary Disease, Lung Diseases, Obstructive
Not yet recruitingPhase 3
The AIRWARD Study: A Study to Test Whether Verducatib Helps People With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Not yet recruiting
Evaluating and Promoting Resilience in Adolescents With Tourette Syndrome
Tourette Syndrome, Tic Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jordi Castellsague, MD, MPH study director
RTI Health Solutions
Susana Perez-Gutthann, MD, PhD study director
RTI Health Solutions
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by AstraZeneca at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Germany, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline age of new users (time frame: Baseline (date of first prescription)). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.