Characteristics and Treatment Patterns of Patients With Chronic Obstructive Pulmonary Disease (COPD), Initiating Tio+Olo or Other Maintenance Therapies in the US and the UK: A Retrospective Claims Database Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 1,371,146
- Locations
- 1
- Primary Endpoint
- Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US
Study Overview
Brief Summary
The primary objectives of the study are to use US and UK data to describe the characteristics of Chronic Obstructive Pulmonary Disease (COPD) patients according to various demographic, lifestyle, clinical, and medication use.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
COPD patients from US IBM Marketscan database
Intervention: Tiotropium bromide + Olodaterol (Drug)
COPD patients from US IBM Marketscan database
Intervention: Sp(t)iolto® Respimat® (Device)
COPD patients from UK CPRD GOLD database
Intervention: Tiotropium bromide + Olodaterol (Drug)
COPD patients from UK CPRD GOLD database
Intervention: Sp(t)iolto® Respimat® (Device)
Outcomes
Primary Outcomes
Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US
Time Frame: At index date of the first maintenance treatment
The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.
Characteristics of Patients Receiving First Maintenance Treatment - US
Time Frame: At index date of the first maintenance treatment
Characteristics of patients receiving first maintenance treatment among chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database were reported.
Age of Patients Receiving First Maintenance Treatment - UK
Time Frame: At index date of the first maintenance treatment
Age of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.
Charlson Comorbidity Index (CCI) at the Time of COPD Diagnosis
Time Frame: At index date of cohort entry (baseline; time of COPD diagnosis).
The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.
Age of Patients Receiving First Maintenance Treatment - US
Time Frame: At index date of the first maintenance treatment
Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported.
Age of Patients Receiving Second Maintenance Treatment - US
Time Frame: At index date of the second maintenance treatment
Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported.
Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - UK
Time Frame: At index date of cohort entry (baseline; time of COPD diagnosis).
Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the the United Kingdom (UK) CPRD GOLD database was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).
Characteristics of Patients Receiving First Maintenance Treatment - UK
Time Frame: At index date of the first maintenance treatment
Characteristics of patients receiving first maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.
Characteristics of Patients Receiving Second Maintenance Treatment - US
Time Frame: At index date of the second maintenance treatment
Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United States (US) IBM MarketScan database were reported.
Age of Patients Receiving Second Maintenance Treatment - UK
Time Frame: At index date of the second maintenance treatment
Age of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported.
Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US
Time Frame: At index date of cohort entry (baseline; time of COPD diagnosis).
Age of the chronic obstructive pulmonary disease (COPD) patients at the time of COPD diagnosis from the United States (US) IBM MarketScan was reported by groups stratified according to their COPD diagnosis times (Before versus after the approval of Tiotropium + Olodaterol in 2015).
Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US
Time Frame: At index date of the second maintenance treatment
The Charlson Comorbidity Index (CCI) was a method of categorizing comorbidities of patients based on the International Classification of Diseases diagnosis. The CCI score ranged from 0 (better outcome) to 21 (worse outcome). The higher the score, the more fragile/ill the patient was.
Characteristics of Patients Receiving Second Maintenance Treatment - UK
Time Frame: At index date of the second maintenance treatment
Characteristics of patients receiving second maintenance treatment from chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported.
Secondary Outcomes
- Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK(At index date of the first maintenance treatment)
- Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK(At index date of the second maintenance treatment)
- Days Between Index and Initiation of First Maintenance Therapy - US(From index date until initiation of first maintenance, up to 3368 days before this study started.)
- Days Between First and Second Maintenance Therapy - US(From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started.)
- Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US(At index date of the first maintenance treatment)
- Days Between Index and Initiation of First Maintenance Therapy - UK(From index date until initiation of first maintenance therapy, up to 9795 days before this study started.)
- Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - US(At index date of the second maintenance treatment)
- Days Between First and Second Maintenance Therapy - UK(From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.)