A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination) (DUS1/DUS2)

February 20, 2018 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark
        • National Health Database Denmark, Southern Denmark University
  • Germany
      • Bremen, Germany
        • German Pharmacoepidemiological Research Database
  • United Kingdom
      • London, United Kingdom
        • Clinical Practice Research Datalink

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Aclidinium bromide
Administered as monotherapy, prescribed as recorded in the database.
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.
Drug: Aclidinium bromide/formoterol
Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.
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.
Drug: Other COPD medication

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Baseline age of new users
Time Frame: Baseline (date of first prescription)
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 (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 (date of first prescription)
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
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
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
From date of first prescription to 1 year of follow-up
Baseline gender of new users
Time Frame: Baseline (date of first prescription)
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
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
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
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
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 (date of first prescription)
Baseline frequency of patients who have experienced a recent exacerbation
Time Frame: Baseline (date of first prescription
Baseline (date of first prescription
Baseline frequency of patients with thyrotoxicosis or pheochromocytoma
Time Frame: Baseline (date of first prescription)
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
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
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
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
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
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
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
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
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 (date of first prescription)
Baseline frequency of patients with bladder neck obstruction
Time Frame: Baseline (date of first prescription)
Baseline (date of first prescription)
Baseline frequency of patients with urinary retention
Time Frame: Baseline (date of first prescription)
Baseline (date of first prescription)
Baseline frequency of patients with narrow-angle glaucoma
Time Frame: Baseline (date of first prescription)
Baseline (date of first prescription)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of COPD medication use
Time Frame: From date of first prescription up to 1 year of follow-up
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.
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
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.
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
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.
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
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
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
From date of first prescription up to 1 year of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RTI Health Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jordi Castellsague, MD, MPH, RTI Health Solutions
  • Study Director: Susana Perez-Gutthann, MD, PhD, RTI Health Solutions

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D6560R00005
  • EUPAS6559 (Registry Identifier: ENCePP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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