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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Tiotropium bromide + Olodaterol; Device: Sp(t)iolto® Respimat®

• Registration Number: NCT04926233
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2020-04-14
• Study Completion: 2020-04-14
• Study First Submitted: 2021-06-13
• Study First Submitted QC: 2021-06-13
• Study First Posted: 2021-06-15
• Results First Submitted: 2021-06-29
• Results First Submitted QC: 2021-06-29
• Results First Posted: 2021-07-20
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1371146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
COPD patients from US IBM Marketscan database	Tiotropium bromide + Olodaterol	-
COPD patients from US IBM Marketscan database	Sp(t)iolto® Respimat®	-
COPD patients from UK CPRD GOLD database	Tiotropium bromide + Olodaterol	-
COPD patients from UK CPRD GOLD database	Sp(t)iolto® Respimat®	-

Primary Outcome Measures

Name	Time	Method
Charlson Comorbidity Index (CCI) of Patients Receiving First Maintenance Treatment - US	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	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	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	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	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	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
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 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.
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 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.
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	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.
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.	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.
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	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.
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.	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.
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	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.
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.	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.

Trial Locations

Locations (1)

AETION inc; 🇺🇸 New York, New York, United States