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

NCT ID: NCT04926233

Last Updated: 2021-11-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1371146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-04-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

COPD patients from US IBM Marketscan database

Tiotropium bromide + Olodaterol

Intervention Type DRUG

Tiotropium bromide + Olodaterol

Sp(t)iolto® Respimat®

Intervention Type DEVICE

Sp(t)iolto® Respimat®

COPD patients from UK CPRD GOLD database

Tiotropium bromide + Olodaterol

Intervention Type DRUG

Tiotropium bromide + Olodaterol

Sp(t)iolto® Respimat®

Intervention Type DEVICE

Sp(t)iolto® Respimat®

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tiotropium bromide + Olodaterol

Tiotropium bromide + Olodaterol

Intervention Type DRUG

Sp(t)iolto® Respimat®

Sp(t)iolto® Respimat®

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Sp(t)iolto® Respimat®

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

AETION inc

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1237-0091

Identifier Type: -

Identifier Source: org_study_id