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

November 12, 2021 updated by: Boehringer Ingelheim
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1371146

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10018
        • AETION inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population for the analysis will consist of all patients with at least one medical claim with a diagnosis code of COPD identified.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
COPD patients from US IBM Marketscan database
Drug: Tiotropium bromide + Olodaterol
Tiotropium bromide + Olodaterol
Other Names:
  • Sp(t)iolto® Respimat®
Device: Sp(t)iolto® Respimat®
Sp(t)iolto® Respimat®
COPD patients from UK CPRD GOLD database
Drug: Tiotropium bromide + Olodaterol
Tiotropium bromide + Olodaterol
Other Names:
  • Sp(t)iolto® Respimat®
Device: Sp(t)iolto® Respimat®
Sp(t)iolto® Respimat®

What is the study measuring?

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
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).
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
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).
At index date of cohort entry (baseline; time of COPD diagnosis).
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.
At index date of cohort entry (baseline; time of COPD diagnosis).
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.
At index date of the first maintenance treatment
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.
At index date of the first maintenance treatment
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.
At index date of the first maintenance treatment
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.
At index date of the first maintenance treatment
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.
At index date of the first maintenance treatment
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.
At index date of the second maintenance treatment
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.
At index date of the second maintenance treatment
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.
At index date of the second maintenance treatment
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.
At index date of the second maintenance treatment
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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
At index date of the second maintenance treatment
Days Between Index and Initiation of First Maintenance Therapy - US
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
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
Time Frame: 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.
From the index date of first maintenance initiation until the initiation of the second maintenance therapy, up to 10133 days before this study started.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2019

Primary Completion (Actual)

April 14, 2020

Study Completion (Actual)

April 14, 2020

Study Registration Dates

First Submitted

June 13, 2021

First Submitted That Met QC Criteria

June 13, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1237-0091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:

  1. studies in products where Boehringer Ingelheim is not the license holder;
  2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials;
  3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datasharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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