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

NCT03543176 | Completed Results FDA Drug FDA Device

• 1 other identifier: 208782
• Study Type: observational
• Target: 789
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Cohort; Chronic obstructive pulmonary disease; Observational; GOLD; Claims; Health plan recruitment

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants That Reported COPD Symptom Burden- Measured Using COPD Assessment Test (CAT) Questionnaire

  The CAT questionnaire is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact). Respondents were allowed to have up to two missing CAT items. If one or two items were missing, the total score was set to the average of the non-missing item scores. Percentage of participants reporting low, medium, high and very high impact COPD symptom burden on CAT scale has been presented. All enrolled Population comprises of all participants with claims \>= 1.

  Day 1

• Percentage of Participants That Reported COPD Symptom Burden- Measured Using Modified Medical Research Council (mMRC) Dyspnea Scale

  Breathlessness was assessed using the mMRC, a single item (0-4) scale assessing current level of dyspnea. The mMRC comprised of five statements that describe almost the entire range of respiratory disability from none (Grade 0) to almost complete incapacity (Grade 4). The score (Grade) was the number that best fit the participant's level of activity. The mMRC categorized participants into low dyspnea (Grades 0-1) and high dyspnea (Grades 2-4).

  Day 1

Secondary Outcomes (17)

• Mean Baseline Comorbidity Burden Score Using Quan-Charlson-clinical Characteristics

  12 months

• Mean Count of Unique Medications-Baseline All Cause Utilization

  12 months

• Mean Total Number of Medications Dispensing-Baseline All Cause Utilization

  12 months

• Percentage of Participants With All Cause Healthcare Resource Utilization

  12 months

• Mean Number of Inpatient Admissions -Baseline All Cause Utilization Counts

  12 months

Study Arms (2)

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; Other: CAT; Other: mMRC; Device: Ellipta

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; Other: CAT; Other: mMRC; Device: Diskus

Interventions

UMEC/VI OTHER

UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .

UMEC/VI

FLUT/SAL OTHER

FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.

FLUT/SAL

CAT OTHER

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

FLUT/SAL; UMEC/VI

mMRC OTHER

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

FLUT/SAL; UMEC/VI

Ellipta DEVICE

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

UMEC/VI

Diskus DEVICE

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

FLUT/SAL

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• \>=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.
• months of continuous enrollment during the Baseline period.
• Ability to complete the study survey in English.

You may not qualify if:

• \>=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

Sponsors & Collaborators

• GlaxoSmithKline: lead
• UnitedHealth Group: collaborator

Study Sites (1)

GSK Investigational Site

Durham, North Carolina, 27709, United States

Location

Biospecimen

Retention: NONE RETAINED

No bio-specimen samples were evaluated.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 1, 2018
• Study Start: May 31, 2018
• Primary Completion: August 21, 2019
• Study Completion: August 21, 2019
• Last Updated: August 5, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)