Clinical trial NCT05393245: Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Official title: Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-05-26
Enrollment: 19467
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with chronic obstructive pulmonary disease (COPD) in routine clinical practice in Taiwan.

Brief summary: The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).


Eligibility criteria: Patients treated with Tio+Olo:

Inclusion criteria:

1. At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date.
4. 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.
5. At least one record in the health insurance system database.

Exclusion criteria:

1. Any use of Tio+Olo in free or fixed form within one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs):

Inclusion criteria:

1. At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019.
2. Aged ≥ 40 years on the index date.
3. At least one diagnosis of COPD at any time prior to or on the index date-
4. 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.
5. At least one record in the health insurance system database.

Exclusion criteria:

1. Any use of LAMA+LABA in free or fixed form for one year prior to the index date.
2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Primary outcomes:
measure: Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
timeFrame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
measure: Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
timeFrame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
Secondary outcomes:
measure: Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex
timeFrame: At index date between 2014-2019. Up to 2160 days.
measure: Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age
timeFrame: At index date between 2014-2019
measure: Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry
timeFrame: At index date between 2014-2019
measure: Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date
timeFrame: At index date between 2014-2019
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date
timeFrame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
measure: Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date
timeFrame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
measure: Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date
timeFrame: Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
measure: Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date
timeFrame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.
Other outcomes:
Locations:
city: Taiwan
country: China
facility: Health Data Research Center, National Taiwan University
Study officials:
References: