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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Tiotropium bromide + Olodaterol
* Device: Sp(t)iolto® Respimat®


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: parent cohort -- COPD diagnosis child cohort -- any initiation of first maintenance therapy after July 1, 2015 grandchild cohort -- any initiation of second maintenance therapy after August 2, 2015 Exclusion criteria: - parent cohort age <40 on index date any COPD diagnosis in baseline any use of long-acting muscarinic antagonists (LAMA), long-acting beta-agonists (LABA), or inhaled corticosteroid (ICS) in baseline <365 days of continuous medical and pharmacy coverage

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COPD patients from US IBM Marketscan database<br> | Drug: Tiotropium bromide + Olodaterol<br>* Tiotropium bromide + Olodaterol<br>* Other names: Sp(t)iolto® Respimat®;Device: Sp(t)iolto® Respimat®<br>* Sp(t)iolto® Respimat®<br>|
| COPD patients from UK CPRD GOLD database<br> | Drug: Tiotropium bromide + Olodaterol<br>* Tiotropium bromide + Olodaterol<br>* Other names: Sp(t)iolto® Respimat®;Device: Sp(t)iolto® Respimat®<br>* Sp(t)iolto® Respimat®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age of the Chronic Obstructive Pulmonary Disease (COPD) Patients at the Time of COPD Diagnosis - US | 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). | 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 - UK | 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). | At index date of cohort entry (baseline; time of COPD diagnosis). | 
| Charlson Comorbidity Index (CCI) at the 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. | At index date of cohort entry (baseline; time of COPD diagnosis). | 
| Age of Patients Receiving First Maintenance Treatment - US | Age of chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United States (US) IBM MarketScan database was reported. | At index date of the first maintenance treatment | 
| Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US | 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. | At index date of the first maintenance treatment | 
| Characteristics of Patients Receiving First Maintenance Treatment - US | 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. | At index date of the first maintenance treatment | 
| Age of Patients Receiving First Maintenance Treatment - UK | 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. | At index date of the first maintenance treatment | 
| Characteristics of Patients Receiving First Maintenance Treatment - UK | 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. | At index date of the first maintenance treatment | 
| Age of Patients Receiving Second Maintenance Treatment - US | Age of patients receiving second maintenance treatment from the United States (US) IBM MarketScan database was reported. | At index date of the second maintenance treatment | 
| Charlson Comorbidity Index (CCI) of Patients Receiving Second Maintenance Treatment - US | 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. | At index date of the second maintenance treatment | 
| Characteristics of Patients Receiving Second Maintenance Treatment - US | 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. | At index date of the second maintenance treatment | 
| Age of Patients Receiving Second Maintenance Treatment - UK | 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. | At index date of the second maintenance treatment | 
| Characteristics of Patients Receiving Second Maintenance Treatment - UK | 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. | At index date of the second maintenance treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - US | Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported. | At index date of the first maintenance treatment | 
| Number of Participants With Zero Exacerbations in the Year Prior to the Start of First Maintenance Therapy - UK | Number of participants with zero exacerbations in the year prior to the start of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported. | 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 - US | Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database was reported. | At index date of the second maintenance treatment | 
| Number of Participants With Zero Exacerbations in the Year Prior to the Start of Second Maintenance Therapy - UK | Number of participants with zero exacerbations in the year prior to the start of second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database was reported. | At index date of the second maintenance treatment | 
| Days Between Index and Initiation of First Maintenance Therapy - US | Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy the United States (US) IBM MarketScan database was reported. | From index date until initiation of first maintenance, up to 3368 days before this study started. | 
| Days Between Index and Initiation of First Maintenance Therapy - UK | Days between index and initiation of first maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their first maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported. | From index date until initiation of first maintenance therapy, up to 9795 days before this study started. | 
| Days Between First and Second Maintenance Therapy - US | Days between first and second maintenance therapy among the chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy the United States (US) IBM MarketScan database were reported. | From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 1020 days before this study started. | 
| Days Between First and Second Maintenance Therapy - UK | Days between first and second maintenance therapy among chronic obstructive pulmonary disease (COPD) patients initiated their second maintenance therapy in the United Kingdom (UK) CPRD GOLD database were reported. | From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started. |