N/A
Completed N=1,617
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
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04011475 ↗
Enrolled (actual)
1,617
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Moderate-to-severe Acute Exacerbation — 20; 22; 9 Participants — p=0.0276
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Moderate-to-severe Acute Exacerbation |
20; 22; 9 | 0.0276 sig |
| SECONDARY Annualized Rate of Moderate-to-severe Exacerbation |
0.28; 0.42; 0.10 | 0.0756 |
| SECONDARY Annualized Rate of Mild Exacerbation |
0.00; 0.04; 0.04 | 0.7394 |
| SECONDARY Annualized Rate of Moderate Exacerbation |
0.19; 0.30; 0.08 | 0.1116 |
| SECONDARY Annualized Rate of Severe Exacerbation |
0.09; 0.12; 0.02 | 0.4164 |
| SECONDARY Incidence of Patients Escalating Therapy (From Single/Dual to Dual/Triple Therapy) |
10; 17; 19 | 0.2035 |
| SECONDARY Percentage of Patients Receiving Dual Therapy Escalated to Triple Therapy or LAMA Escalated to Dual Therapy |
8.8; 14.9; 16.7 | 0.1858 |
| SECONDARY 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 |
-142.0; 20.0; -2.1 | 0.0144 sig |
| SECONDARY 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 |
-74.0; 134.5; 63.7 | 0.2909 |
| SECONDARY 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 |
0.0; 1.0; 2.4 | > 0.9999 |
| SECONDARY 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 |
0.1; 0.1; 0.2 | 0.6189 |
| SECONDARY Percentage of Patients Using Rescue Medications |
58.8; 43.9; 45.6 | 0.0483 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04011475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.