CompletedNot Applicable

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

China19,467 participantsStarted 2022-09-30

Plain-language summary

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

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Aged ≥ 40 years on the index date.
✓. At least one diagnosis of 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.

✕. Any use of Tio+Olo in free or fixed form within 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.
✕. 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.
✕. Aged ≥ 40 years on the index date.
✕. At least one diagnosis of 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.
✕. Any use of LAMA+LABA in free or fixed form for one year prior to the index date.

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.

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.

NCT IDNCT05393245

SponsorBoehringer Ingelheim

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-07

Results submitted2023-12-05

Who can participate

Age range40 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. Aged ≥ 40 years on the index date.
✓. At least one diagnosis of 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.

✕. Any use of Tio+Olo in free or fixed form within 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.
✕. 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.
✕. Aged ≥ 40 years on the index date.
✕. At least one diagnosis of 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.
✕. Any use of LAMA+LABA in free or fixed form for one year prior to the index date.

What they're measuring

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.

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.