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

NCT03333018 | Completed DMC

• 2 other identifiers: D6560R00005EUPAS6559
• Study Type: observational
• Target: 22,155
• Locations: 3 countries
• Sites: 3

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (26)

• Baseline age of new users

  Baseline (date of first prescription)

• Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis

  Baseline (date of first prescription)

• Baseline frequency of new users with severe COPD

  COPD severity including recent exacerbations

  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

  Baseline (date of first prescription)

• Overall comorbidity index of new users

  From date of first prescription up to 1 year of follow-up

• Frequency of respiratory medication use by new users

  From date of first prescription to 1 year of follow-up

• Baseline gender of new users

  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

  From date of first prescription up to 1 year of follow-up

• Frequency of pregnancies during use of COPD medication

  From date of first prescription up to 1 year of follow-up

• Frequency of use of aclidinium bromide in the pediatric population

  From date of first prescription up to 1 year of follow-up

• Frequency of comorbid conditions in the paediatric population

  From date of first prescription up to 1 year of follow-up

• Baseline frequency of patients with renal or hepatic impairment

  Baseline (date of first prescription)

• Baseline frequency of patients who have experienced a recent exacerbation

  Baseline (date of first prescription

• Baseline frequency of patients with thyrotoxicosis or pheochromocytoma

  Baseline (date of first prescription)

• Frequency of previous smoking in new users

  From date of first prescription to 1 year of follow-up

• Frequency of current smokers in new users

  From date of first prescription to 1 year of follow-up

• Frequency of new users with BMI <18.50 kg/m2 (underweight)

  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)

  From date of first prescription to 1 year of follow-up

• Frequency of new users with BMI >25.0 kg/m2 (overweight)

  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)

  From date of first prescription to 1 year of follow-up

• Frequency of new users with BMI >30 kg/m2 (obese)

  From date of first prescription to 1 year of follow-up

• Frequency of new users with low socioeconomic status (Townsend multiple deprivation index)

  From date of first prescription to 1 year of follow-up

• Baseline frequency of patients with benign prostatic hyperplasia

  Baseline (date of first prescription)

• Baseline frequency of patients with bladder neck obstruction

  Baseline (date of first prescription)

• Baseline frequency of patients with urinary retention

  Baseline (date of first prescription)

• Baseline frequency of patients with narrow-angle glaucoma

  Baseline (date of first prescription)

Secondary Outcomes (6)

• Duration of COPD medication use

  From date of first prescription up to 1 year of follow-up

• Average daily dose of COPD medication

  From date of first prescription up to 1 year of follow-up

• Adherence to COPD medication within 1 year

  From date of first prescription up to 1 year of follow-up

• Frequency of use of concomitant medications

  From date of first prescription up to 1 year of follow-up

• Frequency of switching between COPD medications

  From date of first prescription up to 1 year of follow-up

Study Arms (3)

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

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

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

Interventions

Aclidinium bromide DRUG

Administered as monotherapy, prescribed as recorded in the database.

Aclidinium bromide monotherapy

Aclidinium bromide/formoterol DRUG

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

Aclidinium bromide and formoterol

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.

New users of other COPD medication

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead
• RTI Health Solutions: collaborator

Study Sites (3)

National Health Database Denmark, Southern Denmark University

Odense, Denmark

Location

German Pharmacoepidemiological Research Database

Bremen, Germany

Location

Clinical Practice Research Datalink

London, United Kingdom

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

aclidinium bromide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Jordi Castellsague, MD, MPH

  RTI Health Solutions

  STUDY DIRECTOR

• Susana Perez-Gutthann, MD, PhD

  RTI Health Solutions

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: November 6, 2017
• Study Start: July 6, 2015
• Primary Completion: February 28, 2017
• Study Completion: February 28, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

GB (1); DK (1); DE (1)