Early Intervention Efficacy in COPD

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

6788 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-27

Study Completion Date

2020-08-12

Brief Summary

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

This study aims to evaluate the time to escalation to triple therapy among the Japanese Chronic obstructive pulmonary disease (COPD) patients newly initiating therapy with a combination of Olodaterol and Tiotropium (herein referred to as Tio/Olo) using real world data.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to Triple Therapy

NCT04184297

Pulmonary Disease, Chronic Obstructive

COMPLETED

A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.

NCT01703845

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE1

Comparing the Efficacy of Tiotropium + Olodaterol Fixed Dose Combination (FDC) Over Tiotropium in Improvement of Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese COPD Patients

NCT02629965

Pulmonary Disease, Chronic Obstructive

COMPLETED PHASE3

Comparative Effectiveness and Safety of Tiotropium and Olodaterol in Comparison to LABA/ICS

NCT04138758

COPD

COMPLETED

Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan

NCT05402020

Pulmonary Disease, Chronic Obstructive

COMPLETED

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.

Tiotropium/Olodaterol

Combination of Tiotropium and Olodaterol

Tiotropium/Olodaterol

Intervention Type DRUG

Soft Mist Inhaler product

Tiotropium

Intervention Type DRUG

Soft Mist Inhaler product

Interventions

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

Tiotropium/Olodaterol

Soft Mist Inhaler product

Intervention Type DRUG

Tiotropium

Soft Mist Inhaler product

Intervention Type DRUG

Other Intervention Names

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

Spiolto® Spiriva®

Eligibility Criteria

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

Inclusion Criteria

The study cohort will include all patients who initiate Tiotropium/ Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period.

Exclusion Criteria

* Aged \<40 years on cohort entry.
* Any LAMA, LABA, or ICS maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration \>30 days, or any prescription within the 30 days prior to cohort entry.
* Patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period.
* No prior diagnosis of COPD \[International Classification of Diseases (ICD)-10: J41\*, J43\*, J44\* and doubt (UTAGAIFLG) = 0 (no)\]
* Patients without a second prescription claim of their index medication within 60 days after the cohort entry date.
* Diagnosis of asthma \[ICD-10: J45\* and doubt (UTAGAIFLG) = 0 (no)\] during the baseline period.
* Diagnosis of lung cancer \[ICD-10: C34\*, D02.2, Z80.1, Z85.1 and doubt (UTALAIFLG) = 0 (no)\] or lung transplant (Health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data.
* Patients who initiate both Tio/Olo and Tio simultaneously on the cohort entry date.
* Any use of triple therapy (LAMA + LABA + ICS) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No