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

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ClinicalTrials.gov Identifier: NCT03333018
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : February 22, 2018
Sponsor:
Collaborator:
RTI Health Solutions
Information provided by (Responsible Party):
AstraZeneca

Brief 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 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.


Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Drug: Aclidinium bromide Drug: Aclidinium bromide/formoterol Drug: Other COPD medication

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 : Observational
Actual Enrollment : 22155 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
Actual Study Start Date : July 6, 2015
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.





Primary Outcome Measures :
  1. Baseline age of new users [ Time Frame: Baseline (date of first prescription) ]
  2. Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis [ Time Frame: Baseline (date of first prescription) ]
  3. Baseline frequency of new users with severe COPD [ Time Frame: Baseline (date of first prescription) ]
    COPD severity including recent exacerbations

  4. 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

  5. Overall comorbidity index of new users [ Time Frame: From date of first prescription up to 1 year of follow-up ]
  6. Frequency of respiratory medication use by new users [ Time Frame: From date of first prescription to 1 year of follow-up ]
  7. Baseline gender of new users [ Time Frame: Baseline (date of first prescription) ]
  8. 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 ]
  9. Frequency of pregnancies during use of COPD medication [ Time Frame: From date of first prescription up to 1 year of follow-up ]
  10. Frequency of use of aclidinium bromide in the pediatric population [ Time Frame: From date of first prescription up to 1 year of follow-up ]
  11. Frequency of comorbid conditions in the paediatric population [ Time Frame: From date of first prescription up to 1 year of follow-up ]
  12. Baseline frequency of patients with renal or hepatic impairment [ Time Frame: Baseline (date of first prescription) ]
  13. Baseline frequency of patients who have experienced a recent exacerbation [ Time Frame: Baseline (date of first prescription ]
  14. Baseline frequency of patients with thyrotoxicosis or pheochromocytoma [ Time Frame: Baseline (date of first prescription) ]
  15. Frequency of previous smoking in new users [ Time Frame: From date of first prescription to 1 year of follow-up ]
  16. Frequency of current smokers in new users [ Time Frame: From date of first prescription to 1 year of follow-up ]
  17. Frequency of new users with BMI <18.50 kg/m2 (underweight) [ Time Frame: From date of first prescription to 1 year of follow-up ]
  18. 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 ]
  19. Frequency of new users with BMI >25.0 kg/m2 (overweight) [ Time Frame: From date of first prescription to 1 year of follow-up ]
  20. 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 ]
  21. Frequency of new users with BMI >30 kg/m2 (obese) [ Time Frame: From date of first prescription to 1 year of follow-up ]
  22. 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 ]
  23. Baseline frequency of patients with benign prostatic hyperplasia [ Time Frame: Baseline (date of first prescription) ]
  24. Baseline frequency of patients with bladder neck obstruction [ Time Frame: Baseline (date of first prescription) ]
  25. Baseline frequency of patients with urinary retention [ Time Frame: Baseline (date of first prescription) ]
  26. Baseline frequency of patients with narrow-angle glaucoma [ Time Frame: Baseline (date of first prescription) ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Frequency of use of concomitant medications [ Time Frame: From date of first prescription up to 1 year of follow-up ]
  5. Frequency of switching between COPD medications [ Time Frame: From date of first prescription up to 1 year of follow-up ]
  6. Total number of prescriptions [ Time Frame: From date of first prescription up to 1 year of follow-up ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333018


Locations
Denmark
National Health Database Denmark, Southern Denmark University
Odense, Denmark
Germany
German Pharmacoepidemiological Research Database
Bremen, Germany
United Kingdom
Clinical Practice Research Datalink
London, United Kingdom
Sponsors and Collaborators
AstraZeneca
RTI Health Solutions
Investigators
Study Director: Jordi Castellsague, MD, MPH RTI Health Solutions
Study Director: Susana Perez-Gutthann, MD, PhD RTI Health Solutions

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03333018     History of Changes
Other Study ID Numbers: D6560R00005
EUPAS6559 ( Registry Identifier: ENCePP )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018

Keywords provided by AstraZeneca:
COPD

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Formoterol Fumarate
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants