Last updated: 07/17/2024 17:37:22
Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Claims-linked Survey Study to Assess Burden of Illness among Patients Treated with LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subject’s reporting COPD symptoms while treated with FLUT/SAL or UMEC/VI-CAT score
Timeframe: Up to 12 months
Number of subject’s reporting COPD symptoms while treated with FLUT/SAL or UMEC/VI- mMRC score
Timeframe: Up to 12 months
Secondary outcomes:
Number of subject’s with Baseline health care resource utilization
Timeframe: Up to 12 months
Number of subject’s with Baseline health care costs incurred
Timeframe: Up to 12 months
Number of subject’s with evidence of selected clinical characteristics
Timeframe: Up to 12 months
Number of subject’s in each category of GOLD classification
Timeframe: Up to 12 months
Interventions:
Other: UMEC/VI
Other: FLUT/SAL
Other: CAT
Other: mMRC
Device: Ellipta
Device: Diskus
Enrollment:
789
Observational study model:
Cohort
Primary completion date:
2019-21-08
Time perspective:
Cross-Sectional
Clinical publications:
Moretz C, Hahn B, White J, Goolsby Hunter A, Essoi BL, Elliott C, Ray R. Symptom Burden and GOLD Classification in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone Propionate/Salmeterol Therapy. Int J Chron Obstruct Pulmon Dis. 2020;2020(15):2715–2725
DOI: 10.2147/COPD.S265037
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol, umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Optum-data vendor
Study date(s)
May 2018 to August 2019
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
No
- >=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.
- >=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.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Durham, North Carolina, United States, 27709
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2019-21-08
Actual study completion date
2019-21-08
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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