Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
To assess the comparative effectiveness of combination Tiotropium and Olodaterol (Tio+Olo) (FDC) compared to combination LAMA/LABA and ICS (fixed or open), and to explore whether this varies across COPD sub populations defined by exacerbation risk
Interventions
DRUGTiotropium and Olodaterol (Tio+Olo)
drug
DRUGLong-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* New users of Tio+Olo on the same date or of LABA, LAMA and ICS, either as a fixed-dose combination (LABA/LAMA/ICS) or free combination (LABA/ICS + LAMA, etc), on the same date between January 2013 and March 2019. * Diagnosis of COPD prior to first maintenance inhaler and age ≥ 40 years at index date
Exclusion criteria
* Less than one year of medical history information prior to the date of combined treatment initiation (index date) * Lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date * Asthma diagnosis within one year prior to the index date
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). |
| Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry. | Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry. | Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia). |
Countries
United States
Participant flow
Recruitment details
The study investigate the effectiveness and safety of maintenance treatment with combination of tiotropium and olodaterol comparing to maintenance treatment with combination of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) based on existing data.
Pre-assignment details
The study was conducted using existing administrative healthcare claims and laboratory result data captured in the HealthCore Integrated Research Database (HIRD). The observation period was from January 2013 until the most recent date available at the time that the cohort is extracted (March 2019).
Participants by arm
| Arm | Count |
|---|---|
| Tiotropium+Olodaterol All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Tiotropium+Olodaterol (Tio + Olo) treatment from 1 January 2013 until 31 March 2019. | 2,864 |
| LABA/LAMA/ICS All patients in the HealthCore Integrated Research Database (HIRD) with a diagnosis of Chronic obstructive pulmonary disease (COPD) who received combination Long-acting beta2-agonist (LABA) / Long-acting muscarinic antagonists (LAMA) / Inhaled corticosteroids (ICS) treatment from 1 January 2013 until 31 March 2019. | 24,326 |
| Total | 27,190 |
Baseline characteristics
| Characteristic | Tiotropium+Olodaterol | LABA/LAMA/ICS | Total |
|---|---|---|---|
| Age, Continuous | 65.4 Years STANDARD_DEVIATION 10.5 | 66.8 Years STANDARD_DEVIATION 10.7 | 66.7 Years STANDARD_DEVIATION 10.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1349 Participants | 11701 Participants | 13050 Participants |
| Sex: Female, Male Male | 1515 Participants | 12625 Participants | 14140 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
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrence of a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Time frame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Population: Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 1.32 Events per 1000 person-days |
| LABA/LAMA/ICS | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation | 1.14 Events per 1000 person-days |
Comparison: Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.95% CI: [0.76, 0.96]Regression, Cox
Primary
Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry
Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation excluding participants who had exacerbation within 30 days prior to cohort entry, was reported. Time to the first Chronic obstructive pulmonary disease (COPD) exacerbation will be measured from cohort entry until the occurrenceof a hospitalization for COPD (severe exacerbation) or Emergency Department (ED) visit for COPD with the prescription of an antibiotic and/or an oral corticosteroid on the same day (moderate exacerbation).
Time frame: From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to 1 year after cohort entry.
Population: Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, and non-missing endpoint outcomes. Participants with exacerbation within 30 days prior to cohort entry were excluded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | 1.18 Events per 1000 person-days |
| LABA/LAMA/ICS | Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation - Without Exacerbation Within 30 Days Prior to Cohort Entry | 0.99 Events per 1000 person-days |
Comparison: Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of first COPD exacerbation for overall population.95% CI: [0.91, 1.19]Regression, Cox
Secondary
Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia)
Overall incidence rate of first hospitalization for community-acquired pneumonia (serious pneumonia).
Time frame: From cohort entry (index date) until the occurrence of hospitalization for community-acquired pneumonia (serious pneumonia). Up to 1 year after cohort entry.
Population: Patients with Chronic Obstructive Pulmonary Disease (COPD) from HealthCore Integrated Research Database (January 2013 - March 2019) that meet all inclusion criteria, with laboratory result data available and non-missing endpoint outcomes.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tiotropium+Olodaterol | Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | 0.25 Events per 1000 person-days |
| LABA/LAMA/ICS | Overall Incidence Rate of Hospitalization for Community-acquired Pneumonia (Serious Pneumonia) | 0.24 Events per 1000 person-days |
Comparison: Cox proportional hazard regression models were used to assess the effect of Tiotropium + Olodaterol combination versus the Long-acting beta agonist / inhaled corticosteroid (LABA/LAMA/ICS) therapy combination on the risk of a hospitalization for community-acquired pneumonia for overall population.95% CI: [0.64, 1.07]Regression, Cox