Drug Utilization Study for Olodaterol

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Drug Utilization Study for Olodaterol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030638
• Other study ID #: 1222.53
• Status: Completed
• Start date: February 8, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: March 2019
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27606
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Olodaterol
Drug
• Indacaterol
Drug

Locations

Country	Name	City	State
Denmark	Aarhus Universitetshospital Skejby	Aarhus
France	IMS Health Information solutions	Courbevoie
Netherlands	Pharmo Institute	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Boehringer Ingelheim	RTI health solutions, US

Countries where clinical trial is conducted

Denmark,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Baseline Characteristics of New Users of Olodaterol: Age	Baseline characteristics of patients in treatment group by data source: Age	Baseline
Primary	Baseline Characteristics of New Users of Olodaterol: Gender	Baseline characteristics of patients in treatment group by data source: Gender	Baseline
Secondary	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.
Secondary	Baseline Characteristics of New Users of Indacaterol: Age	Baseline characteristics of patients in treatment group by data source: Age	Baseline
Secondary	Baseline Characteristics of New Users of Indacaterol: Gender	Baseline characteristics of patients in treatment group by data source: Gender	Baseline

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