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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— DUS1/DUS2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03333018
• Other study ID #: D6560R00005
• Secondary ID: EUPAS6559
• Status: Completed
• Phase: N/A
• First received: October 6, 2017
• Last updated: February 20, 2018
• Start date: July 6, 2015
• Est. completion date: February 28, 2017

Study information

• Verified date: February 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22155
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Aclidinium bromide
Administered as monotherapy, prescribed as recorded in the database.
• Aclidinium bromide/formoterol
Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.
• 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.

Locations

Country	Name	City	State
Denmark	National Health Database Denmark, Southern Denmark University	Odense
Germany	German Pharmacoepidemiological Research Database	Bremen
United Kingdom	Clinical Practice Research Datalink	London

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	RTI Health Solutions

Countries where clinical trial is conducted

Denmark,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline age of new users		Baseline (date of first prescription)
Primary	Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis		Baseline (date of first prescription)
Primary	Baseline frequency of new users with severe COPD	COPD severity including recent exacerbations	Baseline (date of first prescription)
Primary	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)
Primary	Overall comorbidity index of new users		From date of first prescription up to 1 year of follow-up
Primary	Frequency of respiratory medication use by new users		From date of first prescription to 1 year of follow-up
Primary	Baseline gender of new users		Baseline (date of first prescription)
Primary	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
Primary	Frequency of pregnancies during use of COPD medication		From date of first prescription up to 1 year of follow-up
Primary	Frequency of use of aclidinium bromide in the pediatric population		From date of first prescription up to 1 year of follow-up
Primary	Frequency of comorbid conditions in the paediatric population		From date of first prescription up to 1 year of follow-up
Primary	Baseline frequency of patients with renal or hepatic impairment		Baseline (date of first prescription)
Primary	Baseline frequency of patients who have experienced a recent exacerbation		Baseline (date of first prescription
Primary	Baseline frequency of patients with thyrotoxicosis or pheochromocytoma		Baseline (date of first prescription)
Primary	Frequency of previous smoking in new users		From date of first prescription to 1 year of follow-up
Primary	Frequency of current smokers in new users		From date of first prescription to 1 year of follow-up
Primary	Frequency of new users with BMI <18.50 kg/m2 (underweight)		From date of first prescription to 1 year of follow-up
Primary	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
Primary	Frequency of new users with BMI >25.0 kg/m2 (overweight)		From date of first prescription to 1 year of follow-up
Primary	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
Primary	Frequency of new users with BMI >30 kg/m2 (obese)		From date of first prescription to 1 year of follow-up
Primary	Frequency of new users with low socioeconomic status (Townsend multiple deprivation index)		From date of first prescription to 1 year of follow-up
Primary	Baseline frequency of patients with benign prostatic hyperplasia		Baseline (date of first prescription)
Primary	Baseline frequency of patients with bladder neck obstruction		Baseline (date of first prescription)
Primary	Baseline frequency of patients with urinary retention		Baseline (date of first prescription)
Primary	Baseline frequency of patients with narrow-angle glaucoma		Baseline (date of first prescription)
Secondary	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.	From date of first prescription up to 1 year of follow-up
Secondary	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.	From date of first prescription up to 1 year of follow-up
Secondary	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.	From date of first prescription up to 1 year of follow-up
Secondary	Frequency of use of concomitant medications		From date of first prescription up to 1 year of follow-up
Secondary	Frequency of switching between COPD medications		From date of first prescription up to 1 year of follow-up
Secondary	Total number of prescriptions		From date of first prescription up to 1 year of follow-up

External Links

•   CSR Synopsis