Clinical trial NCT04011475: A Study in Taiwan Based on Medical Records That Looks at the Occurrence of Flare-ups in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Started LABA/LAMA or LAMA Treatment
Official title: Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-07-08
Enrollment: 1617
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: The data will be retrospectively abstracted from the medical chart after eligibility assessment. Eligible patients will be categorized into the cohort A (patients treated with Tio + Olo), B (patients treated with other LABA/LAMA therapy), and C (patients treated with LAMA therapy).

Brief summary: Study to collect the data on Chronic Obstructive Pulmonary Disease (COPD) patients who were administered with Long-Acting Beta-Agonist/ Long-Acting Muscarinic Antagonist (LABA/LAMA) (Fixed-dose Combination (FDC) or free combo) or LAMA treatment


Eligibility criteria: Inclusion Criteria:

Patients who fulfil ALL the following criteria are included.

1. Patients who diagnosed with COPD who were prescribed with LABA/LABA (FDC or free combo) as a new initiation or switching from other therapy (i.e., single/dual/triple), or newly receiving LAMA treatment for 3 months at least prior to 30 June 2018
2. Male or female patients ≥ 40 years of age

Exclusion Criteria:

1. Patients who meet the following criterion are not included.

* Patients with documented diagnosis of bronchial asthma, asthma-COPD overlap syndrome (ACOS), bronchiectasis, cystic fibrosis, or lung cancer

Primary outcomes:
measure: Number of Participants With Moderate-to-severe Acute Exacerbation
timeFrame: Up to 1 year after the index date (Baseline).
Secondary outcomes:
measure: Annualized Rate of Moderate-to-severe Exacerbation
timeFrame: Up to 1 year after the index date (Baseline).
measure: Annualized Rate of Mild Exacerbation
timeFrame: Up to 1 year after the index date (Baseline).
measure: Annualized Rate of Moderate Exacerbation
timeFrame: Up to 1 year after the index date (Baseline).
measure: Annualized Rate of Severe Exacerbation
timeFrame: Up to 1 year after the index date (Baseline).
measure: Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)
timeFrame: Up to 1 year after the index date (Baseline).
measure: Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy
timeFrame: Up to 1 year after index date (Baseline).
measure: Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Expiratory Volume in One Second (Post-FEV1) at 12 Months After Index Date
timeFrame: At index date (Baseline) and at 12 months after index date.
measure: Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 Months After Index Date
timeFrame: At index date (Baseline) and at 12 months after index date.
measure: Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by COPD Assessment Test (CAT) Score at 12 Months After Index Date
timeFrame: At index date (Baseline) and at 12 months after index date.
measure: Change From Baseline in Pulmonary Function After LABA+LAMA or LAMA Initiation Evaluating by Modified Medical Research Council Dyspnea Scale (mMRC) at 12 Months After Index Date
timeFrame: At index date (baseline) and at 12 months after index date
measure: Percentage of Patients Using Rescue Medications
timeFrame: Up to 1 year after index date (Baseline).
Other outcomes:
Locations:
city: Chia YI City
country: Taiwan
facility: Ditmanson Medical Foundation Chia - Yi Christian Hospital
city: Chia YI City
country: Taiwan
facility: CGMH Chia YI
city: Kaohsiung City
country: Taiwan
facility: Eda hospital
city: Kaohsiung City
country: Taiwan
facility: CGMH Kaohsiung
city: New Taipei City
country: Taiwan
facility: Far east memorial hospital
city: Taichung City
country: Taiwan
facility: China medicine memorial hospital
city: Taichung City
country: Taiwan
facility: VGH Taichung
city: Taipei City
country: Taiwan
facility: National Taiwan University hospital
city: Taipei City
country: Taiwan
facility: Makay memorial hospital
city: Taipei City
country: Taiwan
facility: Cheng Hsin general hospital
city: Taipei City
country: Taiwan
facility: Taipei Tzu Chi hospital
city: Taoyuan City
country: Taiwan
facility: CGMH Linkou
Study officials:
References: