Trial Outcomes & Findings for Drug Utilization Study for Olodaterol (NCT NCT03030638)
NCT ID: NCT03030638
Last Updated: 2019-06-27
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
27606 participants
Primary outcome timeframe
01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.
Results posted on
2019-06-27
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Indacaterol - PHARMO Overall
Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1386
|
1841
|
1712
|
6406
|
696
|
1592
|
364
|
127
|
|
Overall Study
PHARMO-GP (Sub-set of PHARMO Overall)
|
372
|
636
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1386
|
1841
|
1712
|
6406
|
696
|
1592
|
364
|
127
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Olodaterol - PHARMO Overall
n=1386 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Indacaterol - PHARMO Overall
n=1841 Participants
Patients from the data source PHARMO overall received Indacaterol inhalation powder for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=1712 Participants
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.
|
Indacaterol - National Health Databases, Denmark
n=6406 Participants
Patients from the data source National Health Databases, Denmark received Indacaterol inhalation powder for the first time, continuing for 12 months.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=696 Participants
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.
|
Indacaterol - IMS RWE LPD GP Panel
n=1592 Participants
Patients from the data source IMS RWE LPD GP Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
|
Olodaterol - IMS RWE LPD Pulmonologist Panel
n=364 Participants
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.
|
Indacaterol - IMS RWE LPD Pulmonologist Panel
n=127 Participants
Patients from the data source IMS RWE LPD Pulmonologist Panel received Indacaterol inhalation powder for the first time, continuing for 12 months.
|
Total
n=14124 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
66.9 Years
STANDARD_DEVIATION 11.33 • n=1386 Participants
|
66.3 Years
STANDARD_DEVIATION 12.83 • n=1841 Participants
|
70.6 Years
STANDARD_DEVIATION 11.12 • n=1712 Participants
|
68.3 Years
STANDARD_DEVIATION 11.45 • n=6406 Participants
|
62.5 Years
STANDARD_DEVIATION 13.77 • n=696 Participants
|
62.4 Years
STANDARD_DEVIATION 14.40 • n=1592 Participants
|
65.8 Years
STANDARD_DEVIATION 13.26 • n=364 Participants
|
67.3 Years
STANDARD_DEVIATION 13.39 • n=127 Participants
|
67.2 Years
STANDARD_DEVIATION 12.09 • n=14124 Participants
|
|
Sex: Female, Male
Female
|
702 Participants
n=1386 Participants
|
887 Participants
n=1841 Participants
|
977 Participants
n=1712 Participants
|
3324 Participants
n=6406 Participants
|
322 Participants
n=696 Participants
|
696 Participants
n=1592 Participants
|
129 Participants
n=364 Participants
|
42 Participants
n=127 Participants
|
7079 Participants
n=14124 Participants
|
|
Sex: Female, Male
Male
|
684 Participants
n=1386 Participants
|
954 Participants
n=1841 Participants
|
735 Participants
n=1712 Participants
|
3082 Participants
n=6406 Participants
|
374 Participants
n=696 Participants
|
896 Participants
n=1592 Participants
|
235 Participants
n=364 Participants
|
85 Participants
n=127 Participants
|
7045 Participants
n=14124 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.Population: Study population
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.
Outcome measures
| Measure |
Olodaterol - PHARMO Overall
n=1386 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - PHARMO-GP
n=372 Participants
Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=1712 Participants
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.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=696 Participants
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.
|
Olodaterol - IMS RWE LPD Pulmonologist Panel
n=364 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Off-label Use of Olodaterol Among New Users
Potential off-label
|
48.6 Percentage of participants
|
19.6 Percentage of participants
|
30.3 Percentage of participants
|
33.9 Percentage of participants
|
17.3 Percentage of participants
|
|
Percentage of Off-label Use of Olodaterol Among New Users
Off-label
|
3.5 Percentage of participants
|
6.2 Percentage of participants
|
4.4 Percentage of participants
|
12.4 Percentage of participants
|
4.9 Percentage of participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Study population
Baseline characteristics of patients in treatment group by data source: Age
Outcome measures
| Measure |
Olodaterol - PHARMO Overall
n=1386 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - PHARMO-GP
n=1712 Participants
Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=696 Participants
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.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=364 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Baseline Characteristics of New Users of Olodaterol: Age
|
68 Years
Interval 60.0 to 75.0
|
71 Years
Interval 64.0 to 78.5
|
63 Years
Interval 53.0 to 72.0
|
67 Years
Interval 59.0 to 75.0
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Study population
Baseline characteristics of patients in treatment group by data source: Gender
Outcome measures
| Measure |
Olodaterol - PHARMO Overall
n=1386 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - PHARMO-GP
n=1712 Participants
Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=696 Participants
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.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=364 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Baseline Characteristics of New Users of Olodaterol: Gender
Female
|
702 Participants
|
977 Participants
|
322 Participants
|
129 Participants
|
—
|
|
Baseline Characteristics of New Users of Olodaterol: Gender
Male
|
684 Participants
|
735 Participants
|
374 Participants
|
235 Participants
|
—
|
SECONDARY outcome
Timeframe: 01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.Population: Study population
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.
Outcome measures
| Measure |
Olodaterol - PHARMO Overall
n=1841 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - PHARMO-GP
n=636 Participants
Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=6406 Participants
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.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=1592 Participants
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.
|
Olodaterol - IMS RWE LPD Pulmonologist Panel
n=127 Participants
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.
|
|---|---|---|---|---|---|
|
Percentage of Off-label Use of Indacaterol Among New Users
Potential off-label
|
61.1 Percentage of participants
|
29.2 Percentage of participants
|
66.6 Percentage of participants
|
34.9 Percentage of participants
|
20.5 Percentage of participants
|
|
Percentage of Off-label Use of Indacaterol Among New Users
Off-label
|
3.5 Percentage of participants
|
6.8 Percentage of participants
|
4.6 Percentage of participants
|
11.9 Percentage of participants
|
9.4 Percentage of participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Study population
Baseline characteristics of patients in treatment group by data source: Age
Outcome measures
| Measure |
Olodaterol - PHARMO Overall
n=1841 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - PHARMO-GP
n=6406 Participants
Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=1592 Participants
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.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=127 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Baseline Characteristics of New Users of Indacaterol: Age
|
67 Years
Interval 59.0 to 75.0
|
69 Years
Interval 61.2 to 76.5
|
63 Years
Interval 53.0 to 73.0
|
68 Years
Interval 59.0 to 78.0
|
—
|
SECONDARY outcome
Timeframe: BaselinePopulation: Study population
Baseline characteristics of patients in treatment group by data source: Gender
Outcome measures
| Measure |
Olodaterol - PHARMO Overall
n=1841 Participants
Patients from the data source PHARMO overall received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - PHARMO-GP
n=6406 Participants
Patients from the data source PHARMO-GP received Olodaterol inhalation solution via Striverdi Respimat inhaler for the first time, continuing for 12 months.
|
Olodaterol - National Health Databases, Denmark
n=1592 Participants
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.
|
Olodaterol - IMS RWE LPD General Practitioner (GP) Panel
n=127 Participants
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.
|
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.
|
|---|---|---|---|---|---|
|
Baseline Characteristics of New Users of Indacaterol: Gender
Female
|
887 Participants
|
3324 Participants
|
696 Participants
|
42 Participants
|
—
|
|
Baseline Characteristics of New Users of Indacaterol: Gender
Male
|
954 Participants
|
3082 Participants
|
896 Participants
|
85 Participants
|
—
|
Adverse Events
Olodaterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Indacaterol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER