N/A
Completed N=789
Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT03543176 ↗
Enrolled (actual)
789
Serious AEs
—
Results posted
Aug 2020
Primary outcomePrimary: Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire — 13.27; 11.34; 51.28; 43.58 Percentage of participants — p=0.448
Summary
The main purpose of the study is to assess the burden of illness for, COPD using both patient-reported symptom burden and claims-based economic burden, among the subjects treated with single-inhaler dual therapy treatments, Fluticasone/Salmeterol FLUT/SAL; Advair) or Umeclidinium/Vilanterol (UMEC/VI; Anoro) to support Global Initiative for Chronic Lung Disease (GOLD) category B recommendations. The study will use a health plan recruitment strategy and subject's will be recruited using Optum's health plan recruitment strategy to collect information relating to the subject's condition history, current treatment, smoking history, symptoms and symptom severity (Modified Medical Research Council Dyspnoea Scale [mMRC] and COPD Assessment Test [CAT]), and demographic and sociodemographic characteristics. A total of 2700 subject's, are planned to be enrolled in the study to reach the target evaluable sample size, n=770 subjects. Following completion of data collection, results of the survey, will be merged with claims data, covering the 12-month Baseline period for analysis. Pharmacy and medical claims data, will be used to calculate all-cause and COPD-related health care utilization and costs, treatment patterns, and Baseline clinical characteristics. The study duration is estimated to be of 12-months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire |
13.27; 11.34; 51.28; 43.58; 30.36; 35.01 | 0.448 |
| PRIMARY Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale |
51.79; 46.85; 48.21; 53.15 | 0.176 |
| SECONDARY Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics |
2.53; 2.49 | 0.732 |
| SECONDARY Mean Count of Unique Medications-Baseline All Cause Utilization |
13.39; 14.52 | 0.013 sig |
| SECONDARY Mean Total Number of Medications Dispensing-Baseline All Cause Utilization |
43.55; 46.22 | 0.178 |
| SECONDARY Percentage of Participants With All Cause Healthcare Resource Utilization |
28.83; 31.49; 44.64; 50.38; 100.00; 100.00 | — |
| SECONDARY Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts |
0.40; 0.47 | — |
| SECONDARY Length of Stay in Hospital-Baseline All Cause Utilization Counts |
3.51; 3.95 | — |
| SECONDARY Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline All Cause Utilization Counts |
0.91; 1.18; 26.79; 25.51; 16.70; 15.54 | — |
| SECONDARY Mean Total Baseline All Cause Healthcare Costs |
19915.66; 17591.88 | — |
| SECONDARY Mean Count of Unique COPD Medications-Baseline COPD Medication |
0.99; 0.99 | 0.692 |
| SECONDARY Mean Total Number of COPD Medications Dispensing-Baseline COPD Medications |
2.50; 1.76 | <0.001 sig |
| SECONDARY Percentage of Participants With COPD Related Baseline Healthcare Resource Utilization |
13.78; 13.60; 10.71; 16.37; 83.93; 75.57 | — |
| SECONDARY Mean Number of Inpatient Admissions -Baseline COPD Related Utilization Counts |
0.17; 0.17 | — |
| SECONDARY Length of Inpatient Stay-Baseline COPD Related Utilization Counts |
2.02; 1.57 | — |
| SECONDARY Mean Number of Emergency Room, Ambulatory, Office and Outpatient Visits-Baseline COPD Related Utilization Counts |
0.16; 0.21; 3.21; 2.38; 2.18; 1.47 | — |
| SECONDARY Mean Total Baseline COPD-related Healthcare Costs |
5008.86; 3797.44 | — |
| SECONDARY Number of Participants With Atleast One Baseline COPD Exacerbation |
164; 184 | — |
| SECONDARY Percentage of Participants in Each Global Initiative for Chronic Lung Disease (GOLD) Category Classification |
43.37; 37.28; 33.42; 38.54; 8.42; 9.57 | — |
Eligibility Criteria
Inclusion Criteria
- >=2 International Statistical Classification of Diseases and Related Health Problems (ICD)-10-CM diagnosis codes for COPD at least 30 days apart during the 12 month period prior to sample identification.
- Diagnosis codes J40-J44 will be included.
- >=1 pharmacy claim for UMEC/VI or FLUT/SAL single-inhaler dual therapy during Baseline.
- Age >= 65 years.
- Self-reported health care provider diagnosis of COPD.
- Self-reported prescription for FLUT/SAL or UMEC/VI.
- 12 months of continuous enrollment during the Baseline period.
- Ability to complete the study survey in English.
Exclusion Criteria
- >=2 ICD-10-CM diagnosis codes for asthma at least 30 days apart during the, 12 month period, prior to sample identification.
- Claims for both UMEC/VI and FLUT/SAL in the 6 months, closest to sample identification.
- Claims for triple therapy (Inhaled Corticosteroid [ICS] + Long-acting Antimuscarinic [LAMA] + Long-acting Beta-agonist [LABA] during the Baseline period.
- Evidence of lung cancer diagnosis and/or treatment
Data sourced from ClinicalTrials.gov (NCT03543176). 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.