N/A
Completed N=11,316
A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT05127304 ↗
Enrolled (actual)
11,316
Serious AEs
—
Results posted
Nov 2023
Primary outcomePrimary: All-cause Health Care Resource Utilization — 32.54; 32.91; 17.80; 17.57 visits/year — p=0.639
Summary
The purpose of this study is to estimate disease-related and all-cause burden and clinical outcomes of interest following initiation of chronic obstructive lung disease (COPD) maintenance therapy with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Health Care Resource Utilization |
32.54; 32.91; 17.80; 17.57; 14.82; 15.42 | 0.639 |
| PRIMARY All-cause Health Care Resource Utilization: Inpatient Days |
4.30; 4.68 | 0.313 |
| PRIMARY All-cause Health Care Resource Utilization: Pharmacy Fills |
59.39; 57.13 | 0.021 sig |
| PRIMARY COPD-related Health Care Resource Utilization |
8.77; 9.56; 3.92; 4.07; 4.85; 5.51 | 0.022 sig |
| PRIMARY COPD-related Health Care Resource Utilization: Inpatient Days |
3.91; 4.42 | 0.163 |
| PRIMARY COPD-related Health Care Resource Utilization: Pharmacy Fills |
15.48; 15.08 | 0.037 sig |
| PRIMARY COPD and/or Pneumonia-related Health Care Resource Utilization |
9.01; 9.85; 4.04; 4.19; 4.98; 5.67 | 0.017 sig |
| PRIMARY COPD and/or Pneumonia-related Health Care Resource Utilization: Inpatient Days |
3.97; 4.49 | 0.162 |
| PRIMARY COPD and/or Pneumonia-related Health Care Resource Utilization: Pharmacy Fills |
15.48; 15.08 | 0.037 sig |
| PRIMARY Pneumonia-related Health Care Resource Utilization |
0.49; 0.66; 0.13; 0.15; 0.36; 0.50 | 0.065 |
| PRIMARY Pneumonia-related Health Care Resource Utilization: Inpatient Days |
1.72; 1.98 | 0.357 |
| PRIMARY COPD or Pneumonia-attributable Health Care Resource Utilization |
4.20; 4.90; 2.09; 2.14; 2.12; 2.77 | 0.002 sig |
| PRIMARY COPD or Pneumonia-attributable Health Care Resource Utilization: Inpatient Days |
2.87; 3.08 | 0.520 |
| PRIMARY COPD or Pneumonia-attributable Health Care Resource Utilization: Pharmacy Fills |
15.48; 15.08 | 0.037 sig |
| PRIMARY All-cause Health Care Costs (Insurer + Patient Paid Amounts) |
16911.48; 18471.61; 7321.14; 7858.06; 2986.46; 3030.56 | 0.060 |
| PRIMARY COPD-related Health Care Costs (Insurer + Patient Paid Amounts) |
9635.45; 10820.05; 2088.43; 2278.21; 468.94; 493.42 | 0.066 |
| PRIMARY COPD and/or Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) |
9828.60; 11065.38; 2121.76; 2316.77; 481.16; 508.60 | 0.057 |
| PRIMARY Pneumonia-related Health Care Costs (Insurer + Patient Paid Amounts) |
2857.23; 3466.72; 80.62; 98.19; 15.03; 18.03 | 0.189 |
| PRIMARY COPD or Pneumonia-attributable Health Care Costs (Insurer + Patient Paid Amounts) |
5630.81; 6006.47; 517.27; 623.53; 231.09; 242.99 | 0.483 |
| PRIMARY Chronic Obstructive Pulmonary Disease (COPD) Exacerbations |
1.02; 0.98; 0.28; 0.26 | 0.205 |
| SECONDARY Percentage of Patients With 30-day All-cause Readmission After COPD Hospitalization |
12.04; 18.25 | 0.060 |
Eligibility Criteria
Inclusion Criteria
- ≥30 consecutive days with Tiotropium Bromide/Olodaterol (TIO/OLO) or Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) initiated during the patient identification period of 01 June 2015 to 30 November 2019. The index date will be the date of the TIO/OLO or FF/UMEC/VI pharmacy claim that starts the ≥30 consecutive days with the medication.
- >1 facility claim with a diagnosis of chronic obstructive lung disease (COPD) in the primary position or ≥2 professional claims with a diagnosis code for COPD in any position on separate dates of service during the study period
- ≥40 years of age as of the year of the index date
- Continuous enrollment with medical and pharmacy coverage for 12 months prior to and including the index date (baseline period)
- Continuous enrollment with medical and pharmacy coverage for ≥30 days following the index date and without discontinuation of the index medication or switch to a non-index regimen (follow-up period); discontinuation and switch as defined in the protocol.
Exclusion Criteria
- ≥2 medical claims with a diagnosis code for asthma, cystic fibrosis, lung cancer, or interstitial lung disease in any position on separate dates of service during the baseline period
- Pharmacy claims for both TIO/OLO and FF/UMEC/VI on the index date
- A pharmacy claim for any non-index COPD maintenance medication on the index date, defined as: long-acting muscarinic antagonists (LAMA) monotherapy; long-acting beta2 agonists (LABA) monotherapy; inhaled corticosteroids (ICS) monotherapy; fixed-dose combination (FDC) ICS/LABA, or FDC LAMA/LABA
- Free or fixed dose LAMA+LABA maintenance therapy defined as ≥7 consecutive days of overlapping days' supply with a LAMA and LABA during a 6-month pre-index period, excluding the index date
-- Flags will be created to identify patients excluded for baseline LAMA/LABA use overall and specifically for each FDC LAMA/LABA medication
- Free or fixed dose triple therapy (TT) defined as ≥7 consecutive days of overlapping days' supply with an ICS, LABA, and LAMA during a 6-month pre-index period, excluding the index date
- ≥1 medical claim with a procedure code for lung volume reduction during the study period
- Unknown age, gender, or business line, or unknown/other geographic region
Data sourced from ClinicalTrials.gov (NCT05127304). 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.