N/A
Completed N=9,117
A Study in the US Based on Pharmacy and Medical Claims That Compares How Well Stiolto® and Trelegy® Work in People With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT05169424 ↗
Enrolled (actual)
9,117
Serious AEs
—
Results posted
Oct 2023
Primary outcomePrimary: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry — 0.28; 0.32 exacerbation per patient-year — p=0.064
Summary
This study looks at data from people with chronic obstructive pulmonary disease (COPD). Some used Stiolto Respimat and the others Trelegy Ellipta as their first treatment for COPD.
The purpose of this study is to find out how well the treatments worked. Researchers compare the time to first COPD flare-up (exacerbation) between the 2 treatments.
The study analyses anonymous data from pharmacy claims collected over 3.5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry |
0.28; 0.32 | 0.064 |
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With no Baseline Exacerbation |
0.25; 0.3 | 0.057 |
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 0 or 1 Baseline Exacerbation |
0.27; 0.31 | 0.114 |
| PRIMARY Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation After Cohort Entry - Among Patients With 2 or More Baseline Exacerbations |
0.49; 0.58 | 0.273 |
| SECONDARY Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) |
0.025; 0.030 | 0.429 |
| SECONDARY Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With no Baseline Exacerbation |
0.024; 0.023 | 0.935 |
| SECONDARY Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 0 or 1 Baseline Exacerbation |
0.024; 0.028 | 0.507 |
| SECONDARY Incidence Rate of Pneumonia Hospitalization (Diagnosis in Any Position) - Among Patients With 2 or More Baseline Exacerbations |
0.075; 0.072 | 0.726 |
| SECONDARY Total Costs of COPD or Pneumonia-related Health Care Cost and Resource Utilization (HCRU) |
9834; 10020 | 0.874 |
| SECONDARY Total Costs of COPD-related HCRU |
9688; 9834 | 0.899 |
| SECONDARY Total Costs of Pneumonia-related HCRU |
2244; 2274 | 0.974 |
| SECONDARY Total Costs of COPD or Pneumonia Attributable HCRU |
5729; 5409 | 0.622 |
| SECONDARY Total Costs of All-cause HCRU |
20849; 19384 | 0.328 |
Eligibility Criteria
Inclusion Criteria
- ≥40 years of age as of the year of the index date
- At least one pharmacy claim for Stiolto Respimat or Trelegy Ellipta.
- For Stiolto Respimat users, the first pharmacy claim of Fixed Dose Combination (FDC) of Tiotropium + Olodaterol (5/5 micrograms (mcg)) will be defined as the index date.
- For Trelegy Ellipta users, the first pharmacy claim of FDC of Fluticasone Furoate + Umeclidinium + Vilanterol (100/62.5/25 mcg), will be defined as the index date.
- Two medical claims (at least one claim on index date or before in the baseline period) with an International Statistical Classification of Diseases and Related Health Problems (ICD)-9/10 diagnosis code(s) for chronic obstructive pulmonary disease (COPD) in any position during the study period (baseline ± post index date).
- At least one year of continuous medical and pharmacy health plan eligibility prior to the index date is required (to allow a baseline period for the covariates and characterizing the study population).
Exclusion Criteria
- To increase the likelihood of a true diagnosis of COPD, we will exclude all patients with two medical claims of asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the study period.
- To restrict the cohort to first line maintenance therapy of Stiolto Respimat or first line maintenance therapy of Trelegy Ellipta we will exclude: patients on long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; free or FDC of: ICS+LABA, LAMA+LABA, ICS+LABA+LAMA therapy within six months prior to index date.
- Pharmacy claims for multiple index medications on the index date.
- Pharmacy claims for non-index COPD maintenance medications on the index date.
Data sourced from ClinicalTrials.gov (NCT05169424). 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.