An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 3 sites in 3 countries. Open to participants aged 28 Days and older. Per ClinicalTrials.gov, last updated 2019-06-27.
Sponsored by Boehringer Ingelheim · Observational
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 27,606 is above the median of 180 across 1,066 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
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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.
Exclusion criteria:
Patients initiating Olodaterol for the first time
Drug: Olodaterol
Patients initiating Indacaterol for the first time
Drug: Indacaterol
Drug
Also known as: STRIVERDI
Drug
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.
Baseline Characteristics of New Users of Olodaterol: Age
Baseline characteristics of patients in treatment group by data source: Age
Time frame: Baseline
Baseline Characteristics of New Users of Olodaterol: Gender
Baseline characteristics of patients in treatment group by data source: Gender
Time frame: Baseline
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.
Baseline Characteristics of New Users of Indacaterol: Age
Baseline characteristics of patients in treatment group by data source: Age
Time frame: Baseline
Baseline Characteristics of New Users of Indacaterol: Gender
Baseline characteristics of patients in treatment group by data source: Gender
Time frame: Baseline
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.
| Milestone | 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 |
|---|---|---|---|---|---|---|---|---|
| Started | 1386 | 1841 | 1712 | 6406 | 696 | 1592 | 364 | 127 |
| Pharmo-gp (sub-set of pharmo overall) | 372 | 636 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 1386 | 1841 | 1712 | 6406 | 696 | 1592 | 364 | 127 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| Percentage of participants | Olodaterol - PHARMO Overall | Olodaterol - PHARMO-GP | Olodaterol - National Health Databases, Denmark | Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Olodaterol - IMS RWE LPD Pulmonologist Panel |
|---|---|---|---|---|---|
| Potential off-label | 48.6 | 19.6 | 30.3 | 33.9 | 17.3 |
| Off-label | 3.5 | 6.2 | 4.4 | 12.4 | 4.9 |
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.
| Percentage of participants | Indacaterol - PHARMO Overall | Indacaterol - PHARMO-GP | Indacaterol - National Health Databases, Denmark | Indacaterol - IMS RWE LPD GP Panel | Indacaterol - IMS RWE LPD Pulmonologist Panel |
|---|---|---|---|---|---|
| Potential off-label | 61.1 | 29.2 | 66.6 | 34.9 | 20.5 |
| Off-label | 3.5 | 6.8 | 4.6 | 11.9 | 9.4 |
Baseline characteristics of patients in treatment group by data source: Age
| Years | Indacaterol - PHARMO Overall | Indacaterol - National Health Databases, Denmark | Indacaterol - IMS RWE LPD GP Panel | Indacaterol - IMS RWE LPD Pulmonologist Panel |
|---|---|---|---|---|
| Baseline Characteristics of New Users of Indacaterol: Age | 67 (59.0 to 75.0) | 69 (61.2 to 76.5) | 63 (53.0 to 73.0) | 68 (59.0 to 78.0) |
Baseline characteristics of patients in treatment group by data source: Age
| Years | Olodaterol - PHARMO Overall | Olodaterol - National Health Databases, Denmark | Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Olodaterol - IMS RWE LPD Pulmonologist Panel |
|---|---|---|---|---|
| Baseline Characteristics of New Users of Olodaterol: Age | 68 (60.0 to 75.0) | 71 (64.0 to 78.5) | 63 (53.0 to 72.0) | 67 (59.0 to 75.0) |
Baseline characteristics of patients in treatment group by data source: Gender
| Participants | Olodaterol - PHARMO Overall | Olodaterol - National Health Databases, Denmark | Olodaterol - IMS RWE LPD General Practitioner (GP) Panel | Olodaterol - IMS RWE LPD Pulmonologist Panel |
|---|---|---|---|---|
| Female | 702 | 977 | 322 | 129 |
| Male | 684 | 735 | 374 | 235 |
Baseline characteristics of patients in treatment group by data source: Gender
| Participants | Indacaterol - PHARMO Overall | Indacaterol - National Health Databases, Denmark | Indacaterol - IMS RWE LPD GP Panel | Indacaterol - IMS RWE LPD Pulmonologist Panel |
|---|---|---|---|---|
| Female | 887 | 3324 | 696 | 42 |
| Male | 954 | 3082 | 896 | 85 |
Collected over Based on the data planned for this study, no suspected adverse events/reactions were expected.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Olodaterol | — | — | — |
| Indacaterol | — | — | — |
Study population: The study population included those patients from the source population who received a first dispensing for single-agent formulations of olodaterol or indacaterol during the study period and had at
| Age, Continuous(Years) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 66.9 ± 11.33 | 66.3 ± 12.83 | 70.6 ± 11.12 | 68.3 ± 11.45 | 62.5 ± 13.77 | 62.4 ± 14.40 | 65.8 ± 13.26 | 67.3 ± 13.39 | 67.2 ± 12.09 |
| Sex: Female, Male(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Female | 702 | 887 | 977 | 3324 | 322 | 696 | 129 | 42 | 7079 |
| Male | 684 | 954 | 735 | 3082 | 374 | 896 | 235 | 85 | 7045 |
| Race and Ethnicity Not Collected(Participants) | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | — | 0 |
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Pulmonary Disease, Chronic Obstructive→
Boehringer Ingelheim