Early Intervention Efficacy in COPD

NCT04249310 | Completed Results FDA Drug

• 1 other identifier: 1237-0100
• Study Type: observational
• Target: 6,788
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Time to Triple Therapy Initiation

  Time to triple therapy initiation (first event per patient) defined as any fixed dose combination of Long-acting muscarinic antagonists (LAMA) / Long-acting beta agonist (LABA) / Inhaled Corticosteroid (ICS) or any concurrent use for 30 consecutive days of the following: * any LAMA/LABA fixed dose combination + any ICS single formulation * any LAMA single formulation + any LABA/ICS fixed dose combination * any LAMA single formulation + any LABA single formulation + any ICS single formulation. Patients will be censored if they had an occurrence of any of the following: outcome (initiation of triple therapy), death, or end of data. The analysis will use an intention-to-treat censoring approach, which does not account for treatment change.

  From index date (cohort entry date) until first occurence of event, up to 42 months.

Secondary Outcomes (2)

• Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

  From index date until first occurence of event, up to 42 months.

• Number of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

  From index date until first occurence of event, up to 42 months.

Study Arms (2)

Tiotropium/Olodaterol

Combination of Tiotropium and Olodaterol

Drug: Tiotropium/Olodaterol

Tiotropium

Drug: Tiotropium

Interventions

Tiotropium/Olodaterol DRUG

Soft Mist Inhaler product

Also known as: Spiolto®

Tiotropium/Olodaterol

Tiotropium DRUG

Soft Mist Inhaler product

Also known as: Spiriva®

Tiotropium

Eligibility Criteria

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

Study Population

The study cohort will include all patients who initiate Tiotropium/Olodaterol (Tio/Olo) or Tiotropium (Tio) during the patient selection period. Initiation (new use) will be determined based on no prescription claims for Tio/Olo or Tio during the baseline period or during all available data prior to cohort entry date. All patients will additionally be required to have a second claim for the index medication within 60 days after cohort entry to ensure primary adherence of index therapy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Nara Medical University

Nara, 634-8522, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

tiotropium-olodaterol; Tiotropium Bromide

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 Centre
• 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: January 29, 2020
• First Posted: January 30, 2020
• Study Start: March 27, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2020
• Last Updated: June 14, 2022
• Results First Posted: August 30, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)