Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DRUGOlodaterol
Drug
DRUGIndacaterol
Drug
Sponsors
RTI health solutions, US
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
28 Days to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: Age | Baseline | Baseline characteristics of patients in treatment group by data source: Age |
| Baseline Characteristics of New Users of Indacaterol: Gender | Baseline | Baseline characteristics of patients in treatment group by data source: Gender |
Countries
Denmark, France, Netherlands
Participant flow
Recruitment details
Participants recruited in the study are those patients who received a first dispensing for single-agent formulations of olodaterol or indacaterol during the study period and had at least 12 months of continuous enrolment in the study databases prior to index date.
Pre-assignment details
Databases used: PHARMO Database Network in the Netherlands, National Registers in Denmark and IMS Health Information Solutions Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. Study periods were 01 March 2014 - 31 December 2016 in PHARMO and Denmark and 01 October 2015 - 30 November 2017 in the IMS RWE LPD panels.
Participants by arm
| Arm | Count |
|---|---|
| Olodaterol - PHARMO Overall Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months. | 1,386 |
| Indacaterol - PHARMO Overall Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months. | 1,841 |
| Olodaterol - National Health Databases, Denmark Patients from the data source National Health Databases, Denmark received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months. | 1,712 |
| Indacaterol - National Health Databases, Denmark Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months. | 6,406 |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel Patients from the data source IMS RWE LPD GP panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months. | 696 |
| Indacaterol - IMS RWE LPD GP Panel Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months. | 1,592 |
| Olodaterol - IMS RWE LPD Pulmonologist Panel Patients from the data source IMS RWE LPD pulmonologist panel received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months. | 364 |
| Indacaterol - IMS RWE LPD Pulmonologist Panel Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months. | 127 |
| Total | 14,124 |
Baseline characteristics
| Characteristic | Olodaterol - PHARMO Overall | Indacaterol - PHARMO Overall | Olodaterol - National Health Databases, Denmark | Indacaterol - National Health Databases, Denmark | Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Indacaterol - IMS RWE LPD GP Panel | Olodaterol - IMS RWE LPD Pulmonologist Panel | Indacaterol - IMS RWE LPD Pulmonologist Panel | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 66.9 Years STANDARD_DEVIATION 11.33 | 66.3 Years STANDARD_DEVIATION 12.83 | 70.6 Years STANDARD_DEVIATION 11.12 | 68.3 Years STANDARD_DEVIATION 11.45 | 62.5 Years STANDARD_DEVIATION 13.77 | 62.4 Years STANDARD_DEVIATION 14.4 | 65.8 Years STANDARD_DEVIATION 13.26 | 67.3 Years STANDARD_DEVIATION 13.39 | 67.2 Years STANDARD_DEVIATION 12.09 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 702 Participants | 887 Participants | 977 Participants | 3324 Participants | 322 Participants | 696 Participants | 129 Participants | 42 Participants | 7079 Participants |
| Sex: Female, Male Male | 684 Participants | 954 Participants | 735 Participants | 3082 Participants | 374 Participants | 896 Participants | 235 Participants | 85 Participants | 7045 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Baseline Characteristics of New Users of Olodaterol: Age
Baseline characteristics of patients in treatment group by data source: Age
Time frame: Baseline
Population: Study population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Olodaterol - PHARMO Overall | Baseline Characteristics of New Users of Olodaterol: Age | 68 Years |
| Olodaterol - PHARMO-GP | Baseline Characteristics of New Users of Olodaterol: Age | 71 Years |
| Olodaterol - National Health Databases, Denmark | Baseline Characteristics of New Users of Olodaterol: Age | 63 Years |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Baseline Characteristics of New Users of Olodaterol: Age | 67 Years |
Primary
Baseline Characteristics of New Users of Olodaterol: Gender
Baseline characteristics of patients in treatment group by data source: Gender
Time frame: Baseline
Population: Study population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Olodaterol - PHARMO Overall | Baseline Characteristics of New Users of Olodaterol: Gender | Female | 702 Participants |
| Olodaterol - PHARMO Overall | Baseline Characteristics of New Users of Olodaterol: Gender | Male | 684 Participants |
| Olodaterol - PHARMO-GP | Baseline Characteristics of New Users of Olodaterol: Gender | Male | 735 Participants |
| Olodaterol - PHARMO-GP | Baseline Characteristics of New Users of Olodaterol: Gender | Female | 977 Participants |
| Olodaterol - National Health Databases, Denmark | Baseline Characteristics of New Users of Olodaterol: Gender | Female | 322 Participants |
| Olodaterol - National Health Databases, Denmark | Baseline Characteristics of New Users of Olodaterol: Gender | Male | 374 Participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Baseline Characteristics of New Users of Olodaterol: Gender | Female | 129 Participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Baseline Characteristics of New Users of Olodaterol: Gender | Male | 235 Participants |
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.
Time frame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
Population: Study population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olodaterol - PHARMO Overall | Percentage of Off-label Use of Olodaterol Among New Users | Potential off-label | 48.6 Percentage of participants |
| Olodaterol - PHARMO Overall | Percentage of Off-label Use of Olodaterol Among New Users | Off-label | 3.5 Percentage of participants |
| Olodaterol - PHARMO-GP | Percentage of Off-label Use of Olodaterol Among New Users | Off-label | 6.2 Percentage of participants |
| Olodaterol - PHARMO-GP | Percentage of Off-label Use of Olodaterol Among New Users | Potential off-label | 19.6 Percentage of participants |
| Olodaterol - National Health Databases, Denmark | Percentage of Off-label Use of Olodaterol Among New Users | Potential off-label | 30.3 Percentage of participants |
| Olodaterol - National Health Databases, Denmark | Percentage of Off-label Use of Olodaterol Among New Users | Off-label | 4.4 Percentage of participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Percentage of Off-label Use of Olodaterol Among New Users | Potential off-label | 33.9 Percentage of participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Percentage of Off-label Use of Olodaterol Among New Users | Off-label | 12.4 Percentage of participants |
| Olodaterol - IMS RWE LPD Pulmonologist Panel | Percentage of Off-label Use of Olodaterol Among New Users | Off-label | 4.9 Percentage of participants |
| Olodaterol - IMS RWE LPD Pulmonologist Panel | Percentage of Off-label Use of Olodaterol Among New Users | Potential off-label | 17.3 Percentage of participants |
Secondary
Baseline Characteristics of New Users of Indacaterol: Age
Baseline characteristics of patients in treatment group by data source: Age
Time frame: Baseline
Population: Study population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Olodaterol - PHARMO Overall | Baseline Characteristics of New Users of Indacaterol: Age | 67 Years |
| Olodaterol - PHARMO-GP | Baseline Characteristics of New Users of Indacaterol: Age | 69 Years |
| Olodaterol - National Health Databases, Denmark | Baseline Characteristics of New Users of Indacaterol: Age | 63 Years |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Baseline Characteristics of New Users of Indacaterol: Age | 68 Years |
Secondary
Baseline Characteristics of New Users of Indacaterol: Gender
Baseline characteristics of patients in treatment group by data source: Gender
Time frame: Baseline
Population: Study population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Olodaterol - PHARMO Overall | Baseline Characteristics of New Users of Indacaterol: Gender | Female | 887 Participants |
| Olodaterol - PHARMO Overall | Baseline Characteristics of New Users of Indacaterol: Gender | Male | 954 Participants |
| Olodaterol - PHARMO-GP | Baseline Characteristics of New Users of Indacaterol: Gender | Male | 3082 Participants |
| Olodaterol - PHARMO-GP | Baseline Characteristics of New Users of Indacaterol: Gender | Female | 3324 Participants |
| Olodaterol - National Health Databases, Denmark | Baseline Characteristics of New Users of Indacaterol: Gender | Male | 896 Participants |
| Olodaterol - National Health Databases, Denmark | Baseline Characteristics of New Users of Indacaterol: Gender | Female | 696 Participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Baseline Characteristics of New Users of Indacaterol: Gender | Female | 42 Participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Baseline Characteristics of New Users of Indacaterol: Gender | Male | 85 Participants |
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.
Time frame: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
Population: Study population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Olodaterol - PHARMO Overall | Percentage of Off-label Use of Indacaterol Among New Users | Off-label | 3.5 Percentage of participants |
| Olodaterol - PHARMO Overall | Percentage of Off-label Use of Indacaterol Among New Users | Potential off-label | 61.1 Percentage of participants |
| Olodaterol - PHARMO-GP | Percentage of Off-label Use of Indacaterol Among New Users | Off-label | 6.8 Percentage of participants |
| Olodaterol - PHARMO-GP | Percentage of Off-label Use of Indacaterol Among New Users | Potential off-label | 29.2 Percentage of participants |
| Olodaterol - National Health Databases, Denmark | Percentage of Off-label Use of Indacaterol Among New Users | Potential off-label | 66.6 Percentage of participants |
| Olodaterol - National Health Databases, Denmark | Percentage of Off-label Use of Indacaterol Among New Users | Off-label | 4.6 Percentage of participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Percentage of Off-label Use of Indacaterol Among New Users | Potential off-label | 34.9 Percentage of participants |
| Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Percentage of Off-label Use of Indacaterol Among New Users | Off-label | 11.9 Percentage of participants |
| Olodaterol - IMS RWE LPD Pulmonologist Panel | Percentage of Off-label Use of Indacaterol Among New Users | Potential off-label | 20.5 Percentage of participants |
| Olodaterol - IMS RWE LPD Pulmonologist Panel | Percentage of Off-label Use of Indacaterol Among New Users | Off-label | 9.4 Percentage of participants |