Clinical trial NCT03030638: Drug Utilization Study for Olodaterol
Official title: Drug Utilization Study for Olodaterol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: RTI health solutions, US
First posted: 2017-01-25
Enrollment: 27606
Sex: ALL
Minimum age (years): 28
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study source population includes all patients enrolled in the selected study databases at the date both olodaterol and indacaterol are available in each database's country. The study is planned to be conducted in the following databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France.

Brief summary: This study aims to characterise the use of single-agent olodaterol and single-agent indacaterol, the only marketed long-acting beta2-agonist (LABA)s authorised for chronic obstructive pulmonary disease (COPD), but not for asthma, in clinical practice.

Detailed description: Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist (LABA), for the indication of chronic obstructive pulmonary disease (COPD). Because the use of LABAs has been associated with increased morbidity and mortality in patients with asthma, the health authorities requested the conduct of a post-approval drug utilisation study to assess potential off-label use of olodaterol in asthma and to characterise the use of olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA authorised in clinical practice for COPD but not for asthma, will also be assessed. Study objectives include the following: (1) Quantify the frequency of off-label use of olodaterol and indacaterol among new users of these medications; and (2) Describe the baseline characteristics of new users of olodaterol and indacaterol. This cross-sectional study will use information among new users of olodaterol or indacaterol collected in the following healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. The source population is all patients enrolled in the selected study databases at the date olodaterol became available in each database's country. The study groups are those patients from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases. The study will describe the number and proportion of new users by indication and potential off-label use and according to medical history and use of co-medications.

Eligibility criteria: Inclusion criteria:

* receive a first prescription/dispensing for single-agent formulations of olodaterol or indacaterol during the study period (no prescriptions/dispensings ever before)
* patients must have at least 12 consecutive months of enrolment in the database before the index date

Exclusion criteria:

- Individuals with missing or implausible values for age or sex will be excluded.

Primary outcomes:
measure: Percentage of Off-label Use of Olodaterol Among New Users
timeFrame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
measure: Baseline Characteristics of New Users of Olodaterol: Age
timeFrame: Baseline
measure: Baseline Characteristics of New Users of Olodaterol: Gender
timeFrame: Baseline
Secondary outcomes:
measure: Percentage of Off-label Use of Indacaterol Among New Users
timeFrame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
measure: Baseline Characteristics of New Users of Indacaterol: Age
timeFrame: Baseline
measure: Baseline Characteristics of New Users of Indacaterol: Gender
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital Skejby
city: Courbevoie
country: France
facility: IMS Health Information solutions
city: Utrecht
country: Netherlands
facility: Pharmo Institute
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: