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Completed

NCT Number: NCT03333018

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

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

National Health Database Denmark, Southern Denmark University, Odense, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aclidinium Bromide

Drug

Administered as monotherapy, prescribed as recorded in the database.

Aclidinium bromide/formoterol

Drug

Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.

Other COPD medication

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • RTI Health Solutions

Registry information

Official study title

Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)

Acronym: DUS1/DUS2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 6, 2017
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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