Drug Utilization Study for Olodaterol

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Indacaterol; Drug: Olodaterol

• Registration Number: NCT03030638
• Lead Sponsor: Boehringer Ingelheim

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.

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-23
• Study First Posted: 2017-01-25
• Study Start: 2017-02-08
• Primary Completion: 2018-03-31
• Study Completion: 2018-03-31
• Status Verified: 2019-03
• Results First Submitted: 2019-03-29
• Results First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Results First Posted: 2019-06-27
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27606

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Indacaterol	Indacaterol	Patients initiating Indacaterol for the first time
Olodaterol	Olodaterol	Patients initiating Olodaterol for the first time

Primary Outcome Measures

Name	Time	Method
Percentage of Off-label Use of Olodaterol Among New Users	01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.	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.
Baseline Characteristics of New Users of Olodaterol: Age	Baseline	Baseline characteristics of patients in treatment group by data source: Age
Baseline Characteristics of New Users of Olodaterol: Gender	Baseline	Baseline characteristics of patients in treatment group by data source: Gender

Secondary Outcome Measures

Name	Time	Method
Percentage of Off-label Use of Indacaterol Among New Users	01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.	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.
Baseline Characteristics of New Users of Indacaterol: Gender	Baseline	Baseline characteristics of patients in treatment group by data source: Gender
Baseline Characteristics of New Users of Indacaterol: Age	Baseline	Baseline characteristics of patients in treatment group by data source: Age

Trial Locations

Locations (3)

IMS Health Information solutions; 🇫🇷 Courbevoie, France

Pharmo Institute; 🇳🇱 Utrecht, Netherlands

Aarhus Universitetshospital Skejby; 🇩🇰 Aarhus, Denmark