Drug Utilization Study for Olodaterol

Study Overview
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Brief Summary
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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
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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.

Official Title
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Drug Utilization Study for Olodaterol

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Olodaterol
* Drug: Indacaterol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Olodaterol<br>Patients initiating Olodaterol for the first time | Drug: Olodaterol<br>* Drug<br>* Other names: STRIVERDI;|
| Indacaterol<br>Patients initiating Indacaterol for the first time | Drug: Indacaterol<br>* Drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Off-label Use of Olodaterol Among New Users | Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period. | 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days. | 
| Baseline Characteristics of New Users of Olodaterol: Age | Baseline characteristics of patients in treatment group by data source: Age | Baseline | 
| Baseline Characteristics of New Users of Olodaterol: Gender | Baseline characteristics of patients in treatment group by data source: Gender | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Off-label Use of Indacaterol Among New Users | Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. | 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days. | 
| Baseline Characteristics of New Users of Indacaterol: Age | Baseline characteristics of patients in treatment group by data source: Age | Baseline | 
| Baseline Characteristics of New Users of Indacaterol: Gender | Baseline characteristics of patients in treatment group by data source: Gender | Baseline |