Drug Utilization Study for Olodaterol

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Olodaterol; Drug: Indacaterol

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 Type: Observational
• Enrollment (Actual): 27606

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Aarhus Universitetshospital Skejby
• France
  • Courbevoie, France
    • IMS Health Information solutions
• Netherlands
  • Utrecht, Netherlands
    • Pharmo Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Olodaterol; Patients initiating Olodaterol for the first time	Drug: Olodaterol; Drug; Other Names: STRIVERDI
Indacaterol; Patients initiating Indacaterol for the first time	Drug: Indacaterol; Drug

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim
• Collaborators: RTI health solutions, US

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): March 31, 2018
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: January 23, 2017
• First Submitted That Met QC Criteria: January 23, 2017
• First Posted (Estimate): January 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 27, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Olodaterol
• Other Study ID Numbers: 1222.53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No