Clinical trial NCT05402020: Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Official title: Effectiveness of Maintenance Treatment With Tiotropium + Olodaterol in Comparison to Inhaled Corticosteroids + Long-acting β2 Agonists 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: 2022-06-02
Enrollment: 17018
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: 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.

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.


Eligibility criteria: Inclusion Criteria:

1. 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.

   1. The first dispensing of either Tio/Olo or LABA/ICS combined inhaler will be defined as the index date;
   2. For the main analyses, only fixed dose combination (FDC) inhalers will be included.
2. Aged ≥ 40 years on the index date (in a sensitivity analysis we will only include patients aged ≥ 55 years on the index date);
3. At least one diagnosis of chronic obstructive pulmonary disease (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, ICS/LABA, or ICS/LABA/ Long-acting muscarinic antagonists (LAMA) 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 (in a sensitivity analysis we will include patients with asthma);

Primary outcomes:
measure: Number of Subjects With Event First Moderate or Severe COPD Exacerbations After Index Date
timeFrame: 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:
measure: Number of Subjects With Event Triple Therapy Escalation After Index Date
timeFrame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.
measure: Incidence Rate of Triple Therapy Initiation
timeFrame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.
measure: Number of Subjects With Event First Hospitalization for Community-acquired Pneumonia After Entry
timeFrame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.
measure: Annualized Rate of Prescriptions of Rescue Medications After the Index Date
timeFrame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.
measure: Annualized Rate of COPD Exacerbations After Index Date
timeFrame: From the index date (The first dispensing of either Tio/Olo or ICS/LABA combined inhaler) until first event, up to 6 years.
Other outcomes:
Locations:
city: Taipei
country: China
facility: National Tawain University Hospital
Study officials:
References: