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

NCT04138758 | Completed Results FDA Drug

• 1 other identifier: 1237-0093
• Study Type: observational
• Target: 42,953
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to compare the effectiveness of maintenance therapy initiation with the combination treatment Tiotropium and Olodaterol (Olo+Tio) compared with LABA/ICS combination in COPD as the time to the first COPD exacerbation. Secondary objectives are to compare patients treated with Tio+Olo and patients treated with LABA/ ICS combination.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

  Incidence rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbation after cohort entry. The event was defined as follows: Severe exacerbation: Hospitalization with a principal discharge diagnosis of COPD. or Moderate exacerbation: An emergency department (ED) visit with a discharge diagnosis of COPD, or, an antibiotic for a respiratory condition dispensed the same day as an oral corticosteroid.

  From cohort entry (index date) until the occurrence of a hospitalization for COPD (severe exacerbation), ED visit for COPD or prescription of an antibiotic and oral corticosteroid on the same day (moderate exacerbation). Up to one year after cohort entry.

Secondary Outcomes (5)

• Incidence Rate of First Hospitalization for Community-acquired Pneumonia

  From cohort entry (index date) until the occurrence of first hospitalization for community-acquired pneumonia (serious pneumonia). Up to one year after cohort entry.

• Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Original Case Definition) to Triple Therapy

  From cohort entry (index date) until the escalation, up to one year after cohort entry.

• Incidence Rate of the First Date of a Pharmacy Dispensing Indicating Escalation (Alternative Case Definition) to Triple Therapy

  From cohort entry (index date) until the escalation, up to one year after cohort entry.

• Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Original Case Definition) to Triple Therapy

  From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry.

• Incidence Rate of Any Element of a Composite Outcome Including Exacerbation, Hospitalization for Pneumonia, or Escalation (Alternative Case Definition) to Triple Therapy

  From cohort entry (index date) until exacerbation, hospitalization (for community-acquired pneumonia) or escalation, up to one year after cohort entry.

Study Arms (2)

Patients initiating Tiotropium+Olodaterol therapy

Drug: Tiotropium bromide + Olodaterol

Patients initiating Long-acting beta agonist/inhaled corticosteroid therapy

Drug: LABA/ICS

Interventions

Tiotropium bromide + Olodaterol DRUG

Tiotropium bromide + Olodaterol

Patients initiating Tiotropium+Olodaterol therapy

LABA/ICS DRUG

Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)

Patients initiating Long-acting beta agonist/inhaled corticosteroid therapy

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

Subjects with COPD inititated with Tio+Olo in comparison to patients treated with ICS/LABA/LAMA

You may qualify if:

• At least one prescription for Tio+Olo combined inhaler or a LABA/ICS combined inhaler between 1 January 2013 and 31 March 2019.
• The first dispensing of either Tio+Olo or LABA/ICS combined inhaler will be defined as the index date.
• For the main analyses, only fixed dose combination (FDC) inhalers will be included. Sensitivity analyses will also accept free combinations of LABA/ICS.
• At least one diagnosis of COPD at any time prior to the index date.
• At least one year of continuous medical and pharmacy health plan eligibility prior to the index date will be required to allow a baseline period for the covariates and identification of new use of the study drugs.

You may not qualify if:

• To increase the likelihood of a true diagnosis of COPD, we will exclude:
• All patients less than 40 years of age on the index date, and
• All patients with a diagnosis of asthma in the year prior to the index date
• To limit the population to those without severe lung compromise outside of COPD, we will exclude individuals with lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date
• To restrict the cohort to new users of Tio+Olo or LABA/ICS, we will exclude any individual with use of either Tio+Olo, LABA/ICS, or LABA/LAMA/ICS combination therapy in free or fixed form for at least one year prior to the index date.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

HealthCore, Inc.

Watertown, Massachusetts, 02472, United States

Location

Related Publications (1)

• Quint JK, Montonen J, Esposito DB, He X, Koerner L, Wallace L, de la Hoz A, Miravitlles M. Effectiveness and Safety of COPD Maintenance Therapy with Tiotropium/Olodaterol versus LABA/ICS in a US Claims Database. Adv Ther. 2021 May;38(5):2249-2270. doi: 10.1007/s12325-021-01646-5. Epub 2021 Mar 15.

  PMID: 33721209 DERIVED

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: October 23, 2019
• First Posted: October 24, 2019
• Study Start: November 1, 2019
• Primary Completion: November 4, 2019
• Study Completion: November 4, 2019
• Last Updated: November 15, 2021
• Results First Posted: November 30, 2020

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)