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

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ClinicalTrials.gov Identifier: NCT03543176
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 19, 2018
Sponsor:
Collaborator:
Optum-data vendor
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Other: UMEC/VI Other: FLUT/SAL Other: CAT Other: mMRC Device: Ellipta Device: Diskus

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Study Type : Observational
Estimated Enrollment : 2700 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Claims-linked Survey Study to Assess Burden of Illness Among Patients Treated With LAMA/LABA vs ICS/LABA Single Inhaler Dual Therapy
Actual Study Start Date : May 31, 2018
Estimated Primary Completion Date : May 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Group/Cohort Intervention/treatment
UMEC/VI
The subjects in this arm had received, UMEC/VI as 62.5/25 microgram (mcg), which is an approved once-daily single inhaler dual LAMA/LABA therapy, given via Ellipta .
Other: UMEC/VI
UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .

Other: CAT
Questionnaire used to asses Condition-related well-being, for COPD subjects.

Other: mMRC
Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.

Device: Ellipta
It is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects.

FLUT/SAL
The subjects in this arm had received, FLUT/SAL as 250/50 mcg, which is an approved twice-daily single inhaler dual therapy ICS/LABA treatment, given via DISKUS.
Other: FLUT/SAL
FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.

Other: CAT
Questionnaire used to asses Condition-related well-being, for COPD subjects.

Other: mMRC
Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.

Device: Diskus
It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.




Primary Outcome Measures :
  1. Number of subject's reporting COPD symptoms while treated with FLUT/SAL or UMEC/VI-CAT score [ Time Frame: Up to 12 months ]
    The number of subject's reporting COPD symptoms will be computed for survey respondents. The number of COPD subjects, who report COPD symptoms as measured by a CAT score.

  2. Number of subject's reporting COPD symptoms while treated with FLUT/SAL or UMEC/VI- mMRC score [ Time Frame: Up to 12 months ]
    The number of subject's reporting COPD symptoms will be computed for survey respondents based on an mMRC score


Secondary Outcome Measures :
  1. Number of subject's with Baseline health care resource utilization [ Time Frame: Up to 12 months ]
    All-cause and COPD-related health care resource utilization, used by the subjects, like the physician office, hospital outpatient visits, emergency department visits, and inpatient stays, will be presented, for the 12-month baseline period.

  2. Number of subject's with Baseline health care costs incurred [ Time Frame: Up to 12 months ]
    All-cause and COPD-related health care costs incurred, like the total costs, pharmacy costs, and medical costs, medical costs include (physician office and hospital outpatient) costs, emergency costs, inpatient costs, and other costs will be presented.

  3. Number of subject's with evidence of selected clinical characteristics [ Time Frame: Up to 12 months ]
    The number of subjects' with evidence of selected clinical characteristics, will be presented. The top 20 claims-based comorbidities and up to 10 COPD-related comorbidities will be identified. The number of subjects with each of the conditions, will be identified and reported.

  4. Number of subject's in each category of GOLD classification [ Time Frame: Up to 12 months ]
    The number of subjects in each GOLD category of symptom burden and exacerbation, will be presented. The calculation will use count of COPD exacerbations during the Baseline combined with CAT total score and mMRC score to create mutually exclusive counts for each category.


Biospecimen Retention:   None Retained
No bio-specimen samples were evaluated.


Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include Medicare Advantage (Medicare) health plan members with evidence of COPD, in the 12 months prior to sample identification and evidence of treatment with UMEC/VI or FLUT/SAL, single-inhaler dual therapy in the six months prior to sample identification. All adults (male and female) subjects with age, greater than or equal to 65 years will be included.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543176


Contacts
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Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
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United States, North Carolina
GSK Investigational Site Recruiting
Durham, North Carolina, United States, 27709
Contact: US GSK Clinical Trials Call Center    877-379-3718      
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466      
Sponsors and Collaborators
GlaxoSmithKline
Optum-data vendor
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03543176     History of Changes
Other Study ID Numbers: 208782
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD for this study will be made available via the Clinical Study Date Request site.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD will be made available, within 6 months of publishing the results of the primary endpoints of the study.
Access Criteria: Access is provided, after a research proposal is submitted and has submitted approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided, for an initial period of 12 months but an extension can be granted, when justified for up to another 12 months.
URL: http://clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by GlaxoSmithKline:
Cohort
Chronic obstructive pulmonary disease
Observational
GOLD
Claims
Health plan recruitment

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes