Clinical trial NCT03333018: A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination)
Official title: Aclidinium Bromide Drug Utilisation Post-Authorisation Safety Studies (DUS): Common Protocol for Aclidinium (DUS1) and Aclidinium/Formoterol Fixed-Dose Combination (DUS2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
First posted: 2017-11-06
Enrollment: 22155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Baseline age of new users
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of new users with a diagnosis of COPD including emphysema or chronic bronchitis
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of new users with severe COPD
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of new users with a history of cardiovascular disease
timeFrame: Baseline (date of first prescription)
measure: Overall comorbidity index of new users
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Frequency of respiratory medication use by new users
timeFrame: From date of first prescription to 1 year of follow-up
measure: Baseline gender of new users
timeFrame: Baseline (date of first prescription)
measure: Frequency of users of aclidinium bromide with comorbid asthma diagnoses or in the absence of other drugs or diagnoses suggestive of COPD
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Frequency of pregnancies during use of COPD medication
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Frequency of use of aclidinium bromide in the pediatric population
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Frequency of comorbid conditions in the paediatric population
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Baseline frequency of patients with renal or hepatic impairment
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of patients who have experienced a recent exacerbation
timeFrame: Baseline (date of first prescription
measure: Baseline frequency of patients with thyrotoxicosis or pheochromocytoma
timeFrame: Baseline (date of first prescription)
measure: Frequency of previous smoking in new users
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of current smokers in new users
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of new users with BMI <18.50 kg/m2 (underweight)
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of new users with BMI ranging from 18.50 to 24.99 kg/m2 (normal weight)
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of new users with BMI >25.0 kg/m2 (overweight)
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of new users with BMI ranging between 25.0 and 29.99 kg/m2 (pre-obese)
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of new users with BMI >30 kg/m2 (obese)
timeFrame: From date of first prescription to 1 year of follow-up
measure: Frequency of new users with low socioeconomic status (Townsend multiple deprivation index)
timeFrame: From date of first prescription to 1 year of follow-up
measure: Baseline frequency of patients with benign prostatic hyperplasia
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of patients with bladder neck obstruction
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of patients with urinary retention
timeFrame: Baseline (date of first prescription)
measure: Baseline frequency of patients with narrow-angle glaucoma
timeFrame: Baseline (date of first prescription)
Secondary outcomes:
measure: Duration of COPD medication use
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Average daily dose of COPD medication
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Adherence to COPD medication within 1 year
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Frequency of use of concomitant medications
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Frequency of switching between COPD medications
timeFrame: From date of first prescription up to 1 year of follow-up
measure: Total number of prescriptions
timeFrame: From date of first prescription up to 1 year of follow-up
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: National Health Database Denmark, Southern Denmark University
city: Bremen
country: Germany
facility: German Pharmacoepidemiological Research Database
city: London
country: United Kingdom
facility: Clinical Practice Research Datalink
Study officials:
affiliation: RTI Health Solutions
name: Jordi Castellsague, MD, MPH
role: STUDY_DIRECTOR
affiliation: RTI Health Solutions
name: Susana Perez-Gutthann, MD, PhD
role: STUDY_DIRECTOR
References: