Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
To compare the persistence in using two different medications from the same drug class (LAMA/LABA FDC) which are delivered through different devices, a dry-powder inhalers (DPI) and Soft Mist Inhalers (SMI).
Interventions
DRUGOlodaterol/Tiotropium Bromide
(Stiolto®) delivered via Respimat inhaler
(Anoro®) delivered via Ellipta Inhaler
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
\-
Exclusion criteria
* Aged \<40 years * Enrolment with medical and pharmacy coverage prior to the cohort entry \< 180 days * Never had COPD diagnosis on the cohort entry date or prior to cohort entry * A record for dispensed Olodaterol/Tiotropium Bromide delivered with Respimat inhalator or Umeclidinium/Vilanterol delivered with the Ellipta Inhaler during the 180-day baseline prior to cohort entry * Diagnosis of asthma any time prior to cohort entry * Diagnosis of lung cancer any time prior to cohort entry * Diagnosis of lung transplant any time prior to cohort entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol) | From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data). | The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days \[not including treatment Switch, nor death\] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation. |
Countries
United States
Participant flow
Recruitment details
The study compared the treatment persistence of patients with Chronic Obstructive Pulmonary Disease (COPD) using Olodaterol/Tiotropium Bromide inhaled via Respimat soft mist inhaler (SMI) versus patients with COPD using Umeclidinium/Vilanterol inhaled via the Ellipta Dry powder inhaler (DPI).
Pre-assignment details
Only subjects that met all inclusion and none of the exclusion criteria were included in the study. Initiators of Olodaterol/Tiotropium Bromide were matched to patients receiving Umeclidinium/Vilanterol using a 1:2 propensity score matching, resulting in a matched cohort of 11296 overall.
Participants by arm
| Arm | Count |
|---|---|
| Olodaterol/Tiotropium Bromide - Matched Cohort Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Olodaterol/Tiotropium Bromide (Stiolto®) delivered with the Respimat soft mist inhaler (SMI), within the Truven MarketScan database between November 2015 and March 2018. | 3,876 |
| Umeclidinium/Vilanterol - Matched Cohort Propensity score matched cohort of patients with Chronic Obstructive Pulmonary Disease (COPD), who initiated Umeclidinium/Vilanterol (Anoro®) delivered with the Ellipta dry powder Inhaler (DPI), within Truven MarketScan database between November 2015 and March 2018. | 7,420 |
| Total | 11,296 |
Baseline characteristics
| Characteristic | Olodaterol/Tiotropium Bromide - Matched Cohort | Umeclidinium/Vilanterol - Matched Cohort | Total |
|---|---|---|---|
| Age, Continuous | 64.63 Years STANDARD_DEVIATION 10.5 | 64.58 Years STANDARD_DEVIATION 10.53 | 64.60 Years STANDARD_DEVIATION 10.52 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1785 Participants | 3409 Participants | 5194 Participants |
| Sex: Female, Male Male | 2091 Participants | 4011 Participants | 6102 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
Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol)
The primary outcome of interest was discontinuation of index treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol), defined as persistence, (i.e. no refill Claim within 60 days \[not including treatment Switch, nor death\] after end of supply) during follow-up. Persistence was assessed by calculating rates of discontinuation in the matched cohorts using a 60-day allowable gap. Rates of discontinuation are reported as the number of events divided by the number of Person-years at risk. Addition of another treatment to index treatment did not count as discontinuation.
Time frame: From first day after the cohort entry date to the earliest occurence of the outcome (discontinuation or refills), or any censoring criteria (365 days of follow-up without discontinuation, death, disenrollment end of data).
Population: 1:2 propensity score matched cohort of initiators of Olodaterol/Tiotropium Bromide and initiators of Umeclidinium/Vilanterol, identified from Truven MarketScan Claims database between November 2015 and March 2018.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Olodaterol/Tiotropium Bromide - Matched Cohort | Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol) | 1826.00 Events per 1000 person-years |
| Umeclidinium/Vilanterol - Matched Cohort | Rate of Discontinuation of Index Treatment (Olodaterol/Tiotropium Bromide or Umeclidinium/Vilanterol) | 1647.03 Events per 1000 person-years |
95% CI: [1.06, 1.17]