Last updated: 07/17/2024 17:37:22

Chronic Obstructive Pulmonary Disease (COPD) Dual Therapy Burden of Illness

GSK study ID
208782
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2019-21-08
    Observational study model:
    Cohort
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    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
    Study complete
    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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