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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04926233
Other study ID # 1237-0091
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2019
Est. completion date April 14, 2020

Study information

Verified date November 2021
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1371146
Est. completion date April 14, 2020
Est. primary completion date April 14, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tiotropium bromide + Olodaterol
Tiotropium bromide + Olodaterol
Device:
Sp(t)iolto® Respimat®
Sp(t)iolto® Respimat®

Locations

Country Name City State
United States AETION inc New York New York

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
Primary 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).
Primary 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).
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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