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

NCT05402020 | Completed Results

• 1 other identifier: 1237-0110
• Study Type: observational
• Target: 17,018
• Locations: 1 country
• Sites: 1

Brief Summary

The real world study aims to assess effectiveness and safety profile between tiotropium/olodaterol (Tio/Olo) and inhaled corticosteroids(ICS) / Long-acting β2-agonists (LABA) in patients with chronic obstructive pulmonary disease (COPD) in Taiwan. The data used in this study will come from the Taiwan National Health Insurance (NHI) claims data between 2014 and 2019.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date

  Number of subjects with event first moderate or severe COPD exacerbations after index date. The first dispensing of either Tio/Olo or ICS/LABA combined inhaler was defined as the index date. Definition of moderate or severe COPD exacerbation: 1. Moderate exacerbation was defined as an outpatient visit with a diagnosis code for COPD in any field and a prescription for an oral corticosteroid or an antibiotic for respiratory infections 2. Severe exacerbation was defined as a hospitalization or emergency room visit with a primary diagnosis for COPD

  From the index date (the first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Secondary Outcomes (5)

• Number of Subjects With Event Triple Therapy Escalation After Index Date

  From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

• Incidence Rate of Triple Therapy Initiation

  From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

• Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry

  From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

• Annualized Rate of Prescriptions of Rescue Medications After the Index Date

  From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

• Annualized Rate of COPD Exacerbations After Index Date

  From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.

Study Arms (2)

Tiotropium + Olodaterol cohort

Subjects who initiated Tiotropium + Olodaterol between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.

Drug: Tiotropium (Tio); Drug: Olodaterol (Olo)

Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort

Subjects who initiated Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) between 1st January 2014 and 31st December 2019 according to data from the Taiwan National Health Insurance (NHI), Taiwan Cancer Registry (TCR) and Taiwan Mortality Data.

Drug: Inhaled corticosteroids (ICS); Drug: Long-acting β2-agonists (LABA)

Interventions

Tiotropium (Tio) DRUG

Tiotropium (Tio)

Tiotropium + Olodaterol cohort

Inhaled corticosteroids (ICS) DRUG

Inhaled corticosteroids (ICS)

Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort

Olodaterol (Olo) DRUG

Olodaterol (Olo)

Tiotropium + Olodaterol cohort

Long-acting β2-agonists (LABA) DRUG

Long-acting β2-agonists (LABA)

Inhaled Corticosteroids (ICS) + Long-acting ß2 agonists (LABA) cohort

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

Patients with chronic obstructive pulmonary disease, included in the NHI database between 2014 and 2019, who received either Tiotropium + Olodaterol or Inhaled Corticosteroids + Long-acting ß2 agonist.

You may qualify if:

• At least one prescriptions for Tiotropium/Olodaterol (Tio/Olo) combined inhaler or Long-acting ß2 agonist / Inhaled Corticosteroids (LABA/ICS) combined inhaler between 1st January 2014 and 31st December 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.
• Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
• At least one diagnosis of chronic obstructive pulmonary disease (COPD) at any time prior to or on the index date;
• At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs;
• At least one record in the health insurance system database

You may not qualify if:

• Any use of Tio/Olo, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) in free or fixed form for one year prior to the index date;
• Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date (in a sensitivity analysis we will include patients with asthma);

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

National Tawain University Hospital

Taipei, 100225, China

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

Limitations and Caveats

Clinically important parameters and reasons for using medications were not available. Anticipated is that a certain level of misclassification of disease conditions occurred. Not accounting for such confounders may have resulted in biased findings. Follow-up was censored resulting in limited follow-up time. This may have compromised statistical power, but was not likely to contribute substantial bias in the comparisons. SEAP template does not contain a document date as per internal SOP.

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: May 30, 2022
• First Posted: June 2, 2022
• Study Start: September 30, 2022
• Primary Completion: February 13, 2023
• Study Completion: February 13, 2023
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)