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Completed

NCT Number: NCT03030638

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.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

28 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus Universitetshospital Skejby, Aarhus, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olodaterol

Drug

Drug

Other names: STRIVERDI

Indacaterol

Drug

Drug

Primary outcomes

  1. Percentage of Off-label Use of Olodaterol Among New Users

    Time frame: 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.

  2. Baseline Characteristics of New Users of Olodaterol: Age

    Time frame: Baseline

    Baseline characteristics of patients in treatment group by data source: Age

  3. Baseline Characteristics of New Users of Olodaterol: Gender

    Time frame: Baseline

    Baseline characteristics of patients in treatment group by data source: Gender

Secondary outcomes

  1. Percentage of Off-label Use of Indacaterol Among New Users

    Time frame: 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.

  2. Baseline Characteristics of New Users of Indacaterol: Age

    Time frame: Baseline

    Baseline characteristics of patients in treatment group by data source: Age

  3. Baseline Characteristics of New Users of Indacaterol: Gender

    Time frame: Baseline

    Baseline characteristics of patients in treatment group by data source: Gender

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • RTI Health Solutions

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 25, 2017
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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