Pulmonary Disease, Chronic ObstructiveNCT03030638
Drug Utilization Study for Olodaterol
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 28 days and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Olodaterol and Indacaterol
- How many people
- 27,606 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 8 Feb 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Individuals with missing or implausible values for age or sex will be excluded.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Olodaterol, Indacaterol
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlodaterolDrug
Also called STRIVERDI
Drug
IndacaterolDrug
Drug
| Study group | Role | What they receive |
|---|---|---|
| Olodaterol | Patients initiating Olodaterol for the first time Receives: Drug: Olodaterol | |
| Indacaterol | Patients initiating Indacaterol for the first time Receives: Drug: Indacaterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline
Baseline Characteristics of New Users of Olodaterol: Gender
Baseline characteristics of patients in treatment group by data source: Gender
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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
Measured: Baseline
Baseline Characteristics of New Users of Indacaterol: Gender
Baseline characteristics of patients in treatment group by data source: Gender
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start8 Feb 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 27,606 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03030638
- Sponsor's protocol ID
- 1222.53
- Status last verified
- Mar 2019
- First submitted
- 23 Jan 2017
- Last updated
- 27 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Study for Olodaterol
- ClinicalTrials.gov ID
- NCT03030638
- Acronym / sponsor ID
- 1222.53
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,606 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 25 Jan 2017 (estimated)
- Results
- Posted 27 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olodaterol | – | Drug: OlodaterolPatients initiating Olodaterol for the first time |
| Indacaterol | – | Drug: IndacaterolPatients initiating Indacaterol for the first time |
Who may qualify
- Ages
- 28 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals with missing or implausible values for age or sex will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlodaterolAlso: STRIVERDIDrug | Drug | Olodaterol |
| IndacaterolDrug | Drug | Indacaterol |
Primary outcome
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.
Baseline Characteristics of New Users of Olodaterol: Age
Time frame: Baseline
Baseline characteristics of patients in treatment group by data source: Age
Baseline Characteristics of New Users of Olodaterol: Gender
Time frame: Baseline
Baseline characteristics of patients in treatment group by data source: Gender
3 secondary outcomes
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.
Baseline Characteristics of New Users of Indacaterol: Age
Time frame: Baseline
Baseline Characteristics of New Users of Indacaterol: Gender
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.