Last updated: 05/01/2019 18:30:27
Claims-linked Survey Study to Assess Patient-reported COPD Symptoms and Burden of Illness among a Prevalent Population
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Claims-linked Survey Study to Assess Patient-reported COPD Symptoms and Burden of Illness among a Prevalent Population
Trial description: COPD is a prevalent respiratory condition characterized by a gradual loss of lung function and progressive airflow limitation leading to conditions like dyspnea. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) Science Committee guidelines emphasize treatment regimens based on disease severity. Among subjects with higher symptoms and lower exacerbation risk, long-acting muscarinic antagonist (LAMA) monotherapy is recommended as first-line treatment, with LAMA+long-acting beta-agonists (LABA) combination therapy as an alternative treatment for these subjects. Treated COPD subjects, however, may continue to experience dyspnea and other COPD-related symptoms. The aim of this study is to assess the subject-reported and economic burden of COPD by examining symptoms and resource utilization among a prevalent population of subjects treated with LAMA monotherapy.This is a claims-linked cross-sectional survey study of commercial and Medicare Advantage (MA) enrollees of a large United States (US) health plan with evidence of COPD and currently receiving treatment with monotherapy. Study subjects will be identified from health plan database using administrative claims data from a 12-month period beginning October 1, 2015 and ending September 30, 2016. A target population of 2,275 potential study subjects will be contacted directly by mail with initial study packets containing the study survey and diary and will be invited to participate in the study. Subjects will be asked to return the study survey and diary if they consent to participate. The cross-sectional survey and 7-day daily diary will collect information on subject’s COPD symptoms, condition duration, condition-related quality of life, general health and well-being, current treatment, and demographic and sociodemographic characteristics. The estimated time for survey completion is about 10-12 minutes and the daily diary is 3-5 minutes. Data collection will occur over the course of nine weeks. Following completion of survey data collection and the 4-month administrative claims lag, 12 months of surveyed subject’s pharmacy and medical claims data for the baseline period will be re-extracted. The results of the survey will be merged with claims data covering the period 12 months prior to the survey sample identification for analysis (baseline period). The survey data and health care claims data will be combined and analyzed.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Subject reported burden of illness based on COPD assessment test (CAT) scores
Timeframe: Up to 9 weeks (survey field period)
Subject reported symptom severity based on Exacerbations of Chronic Pulmonary Disease Tool (EXACT-PRO) Scores
Timeframe: Up to 9 weeks (survey field period)
Subject reported dyspnea severity based on Modified Medical Research Council Dyspnea scale (mMRC) scores.
Timeframe: Up to 9 weeks (survey field period)
Subject reported quality of life based on Medical Outcomes Study (MOS) Short Form Health Surveys, 12 item (SF-12V2) domain scores
Timeframe: Up to 9 weeks (survey field period)
Number of subjects reporting COPD symptoms while treated with monotherapy
Timeframe: Up to 9 weeks (survey field period)
Secondary outcomes:
Evaluation of Baseline health care resource utilization (HCRU)
Timeframe: Up to 12 months (baseline period)
Evaluation of Baseline health care costs
Timeframe: Up to 12 months (baseline period)
Number of subjects with evidence of clinical characteristics
Timeframe: Up to 12 months (baseline period)
Interventions:
Enrollment:
Not applicable
Primary completion date:
2017-18-07
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Hahn B, Stanford R, Goolsby-Hunter A, Essoi B, White J, Ray R. Patient-reported Burden of Illness in a Prevalent COPD Population Treated with Long-Acting Muscarinic Antagonist Monotherapy: A Claims-linked Patient Survey Study. Pulm Ther. 2019;:1-12
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
umeclidinium bromide, umeclidinium bromide/vilanterol, vilanterol
Collaborators
Optum-data vendor
Study date(s)
January 2017 to July 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
Not applicable
- 2 or more COPD diagnosis codes at least 30 days apart during the 12-month baseline period. Diagnosis codes can be in any position on the medical claim. ICD-10-CM diagnosis codes are included based on the study sample identification period, which is estimated to begin no earlier than October 2015. Codes J40-J44 will be used to identify COPD, which is commensurate with current Centers for Disease Control and Prevention (CDC) measurement of COPD.
- 2 or more pharmacy or medical claims for COPD LAMA monotherapy treatment in the 6 months prior and closest to sample identification in the absence of pharmacy claims for dual or triple therapy treatment. Feasibility of requiring 2 or more pharmacy claims for COPD LAMA monotherapy treatment will be investigated at the time of sample identification. If adequate sample is not available, 1 or more LAMA pharmacy claim will be required.
- Subjects with prescription claims for prior use of inhaled corticosteroids (ICS) or LAMA monotherapy treatment during the 12-month sample identification period will be excluded.
- Subjects with evidence of dual therapy or triple therapy during the 12-month baseline period will be excluded. Dual therapy and triple therapy will be defined as claims for formulations of ICS/LABA, anticholinergic/LABA, ICS/LABA/LAMA. Claims for both fixed-dose combinations (FDC) and combined monotherapy formulations of dual and triple therapy treatments will be excluded. Multiple monotherapy prescription claims may be considered to comprise dual or triple therapy in the following cases: Same-day fills: All claims occur on the same calendar date; 30 day period: All claims occur within 30 days of each other; and/or 60 day period. All claims occur within 60 days of each other (that is., there is less than a 30 day gap between run-out of any medications comprising the combination therapy).
Inclusion and exclusion criteria
Inclusion criteria:
- 2 or more COPD diagnosis codes at least 30 days apart during the 12-month baseline period. Diagnosis codes can be in any position on the medical claim. ICD-10-CM diagnosis codes are included based on the study sample identification period, which is estimated to begin no earlier than October 2015. Codes J40-J44 will be used to identify COPD, which is commensurate with current Centers for Disease Control and Prevention (CDC) measurement of COPD.
- 2 or more pharmacy or medical claims for COPD LAMA monotherapy treatment in the 6 months prior and closest to sample identification in the absence of pharmacy claims for dual or triple therapy treatment. Feasibility of requiring 2 or more pharmacy claims for COPD LAMA monotherapy treatment will be investigated at the time of sample identification. If adequate sample is not available, 1 or more LAMA pharmacy claim will be required.
- Subjects may take appropriate COPD medications of interest.
- Age 40 and older.
- 12 months of baseline continuous enrollment during the period prior to sample identification in the large, geographically diverse US health plan affiliated with Optum.
- Ability to complete the study survey and diary in English
Exclusion criteria:
- Subjects with prescription claims for prior use of inhaled corticosteroids (ICS) or LAMA monotherapy treatment during the 12-month sample identification period will be excluded.
- Subjects with evidence of dual therapy or triple therapy during the 12-month baseline period will be excluded. Dual therapy and triple therapy will be defined as claims for formulations of ICS/LABA, anticholinergic/LABA, ICS/LABA/LAMA. Claims for both fixed-dose combinations (FDC) and combined monotherapy formulations of dual and triple therapy treatments will be excluded. Multiple monotherapy prescription claims may be considered to comprise dual or triple therapy in the following cases: Same-day fills: All claims occur on the same calendar date; 30 day period: All claims occur within 30 days of each other; and/or 60 day period. All claims occur within 60 days of each other (that is., there is less than a 30 day gap between run-out of any medications comprising the combination therapy).
- Optum and GlaxoSmithKline (GSK) will review the impact on sample size of the dual and triple therapy definitions and may elect to use a subset of these definitions for identification of the final survey sample.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
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
2017-18-07
Actual study completion date
2017-18-07
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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