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Completed

NCT Number: 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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CGMH Chia YI, Chia YI City, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who fulfil ALL the following criteria are included.

  • 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
  • Male or female patients ≥ 40 years of age

Exclusion criteria

  • 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

Treatment and study plan

tiotropium + olodaterol

Drug

Spiolto®

Other LABA/LAMA

Drug

tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium

LAMA

Drug

aclidinium bromide, glycopyrronium, tiotropium, umeclidinium

Primary outcomes

  1. Number of Participants With Moderate-to-severe Acute Exacerbation

    Time frame: Up to 1 year after the index date (Baseline).

    Number of participants with moderate-to-severe acute exacerbation within 1 year after the index date was reported.

Secondary outcomes

  1. Annualized Rate of Moderate-to-severe Exacerbation

    Time frame: Up to 1 year after the index date (Baseline).

    The annualized rate of moderate-to-severe exacerbation was calculated as: total number of episodes of moderate-to-severe exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.

  2. Annualized Rate of Mild Exacerbation

    Time frame: Up to 1 year after the index date (Baseline).

    The annualized rate of mild exacerbation was calculated as: total number of episodes of mild exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.

  3. Annualized Rate of Moderate Exacerbation

    Time frame: Up to 1 year after the index date (Baseline).

    The annualized rate of moderate exacerbation was calculated as: total number of episodes of moderate exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.

  4. Annualized Rate of Severe Exacerbation

    Time frame: Up to 1 year after the index date (Baseline).

    The annualized rate of severe exacerbation was calculated as: total number of episodes of severe exacerbation of all participants divided by the sum of follow-up period [years] of all participants. The corresponding 95% confidence interval was from Poisson regression.

  5. Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy)

    Time frame: Up to 1 year after the index date (Baseline).

    Incidence of patients escalating therapy, from single/dual to dual/triple therapy such as receiving Long-Acting Muscarinic Antagonist (LAMA) escalated to dual therapy or receiving LABA+LAMA (Tiotropium+Olodaterol) escalated to triple therapy(LABA+LAMA+inhaled corticosteroids (ICS)), within 1 year after the index date was reported.

  6. Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy

    Time frame: Up to 1 year after index date (Baseline).

    Percentage of patients receiving dual therapy (Tiotropium+Olodaterol or other Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) therapy) escalated to triple therapy (LABA+LAMA + inhaled corticosteroids (ICS)) or LAMA escalated to dual therapy (LABA + LAMA) was reported.

  7. 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

    Time frame: At index date (Baseline) and at 12 months after index date.

    Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by post-bronchodilatorForced Expiratory Volume in one second (Post-FEV1) at 12 months after index date was reported.

    Spirometry was the most common tool to evaluate the lung function of patients with respiratory disease. Among the results of spirometry, post-bronchodilator Forced Expiratory Volume in one second was used for assisting in the diagnosis, determining disease severity, and following up the prognosis.

  8. 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

    Time frame: At index date (Baseline) and at 12 months after index date.

    Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by post-bronchodilator Forced Volume Vital Capacity (Post-FVC) at 12 months after index date was reported.

    Spirometry was the most common tool to evaluate the lung function of patients with respiratory disease. Among the results of spirometry, post-bronchodilator Forced Volume Vital Capacity was used for assisting in the diagnosis, determining disease severity, and following up the prognosis.

  9. 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

    Time frame: At index date (Baseline) and at 12 months after index date.

    Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) score at 12 months after index date was reported.

    The COPD assessment test (CAT) was a simple, 8-item, health status instrument which provided a simple method for assessing the impact of COPD on the patient's health and the quality of life. Each item was on a 6-point scale: 0 (no impact) to 5 (maximum impact). The CAT score ranging from 0 (better health status) to 40 (worse health status) was calculated by summing the points for each item. A decrease in CAT score represents an improvement in health status, whereas an increase in CAT score represents a worsening in health status.

  10. 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

    Time frame: At index date (baseline) and at 12 months after index date

    Change from baseline in pulmonary function after Long-Acting Beta-Agonist (LABA)+Long-Acting Muscarinic Antagonist (LAMA) (Tiotropium+Olodaterol or other LABA+LAMA therapy) or LAMA initiation evaluating by modified Medical Research Council dyspnea scale (mMRC) at 12 months after index date is reported.

    Modified Medical Research Council dyspnea scale (mMRC) is a 5 points scale measuring the severity of dyspnea of patients. The scale ranges from 0 (better outcome) to 4 (worse outcome). The higher the scale value, the more severe the dyspnea is. If mMRC scale of the patient was > 2, it means the patient may suffer from dyspnea.

  11. Percentage of Patients Using Rescue Medications

    Time frame: Up to 1 year after index date (Baseline).

    Percentage of patients using rescue medications within 1 year after index date was reported.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Taiwan Outcomes and Real-world Treatment Options for Chronic Obstructive Pulmonary Disease

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2019
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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