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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olodaterol | Patients initiating Olodaterol for the first time |
| |
| Indacaterol | Patients initiating Indacaterol for the first time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olodaterol | Drug | Drug |
|
|
| 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 |
| 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. |
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Inclusion criteria:
Exclusion criteria:
- Individuals with missing or implausible values for age or sex will be excluded.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital Skejby | Aarhus | Denmark | ||||
| IMS Health Information solutions |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Indacaterol - PHARMO Overall | Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| FG006 | 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. |
| FG007 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Indacaterol - PHARMO Overall |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Study population | Posted | Number | Percentage of participants | 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days. |
|
Based on the data planned for this study, no suspected adverse events/reactions were expected.
Adverse Events were not monitored/assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olodaterol | Patients initiating Olodaterol for the first time | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 13, 2014 | Mar 29, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 16, 2017 | Mar 29, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C549647 | olodaterol |
| C510790 | indacaterol |
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| Indacaterol |
| Drug |
Drug |
|
| 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 |
| Courbevoie |
| France |
| Pharmo Institute | Utrecht | Netherlands |
Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | 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. |
| BG005 | 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. |
| BG006 | 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. |
| BG007 | 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. |
| BG008 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG001 | Olodaterol - PHARMO-GP | Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months. |
| OG002 | 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. |
| OG003 | 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. |
| OG004 | 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. |
|
|
| 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. | Study population | Posted | Number | Percentage of participants | 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days. |
|
|
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| Secondary | Baseline Characteristics of New Users of Indacaterol: Age | Baseline characteristics of patients in treatment group by data source: Age | Study population | Posted | Median | Inter-Quartile Range | Years | Baseline |
|
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| Primary | Baseline Characteristics of New Users of Olodaterol: Age | Baseline characteristics of patients in treatment group by data source: Age | Study population | Posted | Median | Inter-Quartile Range | Years | Baseline |
|
|
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| Primary | Baseline Characteristics of New Users of Olodaterol: Gender | Baseline characteristics of patients in treatment group by data source: Gender | Study population | Posted | Count of Participants | Participants | Baseline |
|
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| Secondary | Baseline Characteristics of New Users of Indacaterol: Gender | Baseline characteristics of patients in treatment group by data source: Gender | Study population | Posted | Count of Participants | Participants | Baseline |
|
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|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Indacaterol | Patients initiating Indacaterol for the first time | 0 | 0 | 0 | 0 | 0 | 0 |
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
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| Off-label |
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| Male |
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| Male |
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