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

NCT04926233 | Completed Results FDA Drug FDA Device

• 1 other identifier: 1237-0091
• Study Type: observational
• Target: 1,371,146
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (13)

• 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).

• 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).

• 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).

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• 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 - UK

  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

  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

  At index date of the second maintenance treatment

• 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.

Study Arms (2)

COPD patients from US IBM Marketscan database

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

COPD patients from UK CPRD GOLD database

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

Interventions

Tiotropium bromide + Olodaterol DRUG

Tiotropium bromide + Olodaterol

Also known as: Sp(t)iolto® Respimat®

COPD patients from UK CPRD GOLD database; COPD patients from US IBM Marketscan database

Sp(t)iolto® Respimat® DEVICE

Sp(t)iolto® Respimat®

COPD patients from UK CPRD GOLD database; COPD patients from US IBM Marketscan database

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

AETION inc

New York, New York, 10018, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide; olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: June 15, 2021
• Study Start: November 15, 2019
• Primary Completion: April 14, 2020
• Study Completion: April 14, 2020
• Last Updated: November 15, 2021
• Results First Posted: July 20, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)