Burden of Disease Among Subjects With Eosinophilic Chronic Obstructive Pulmonary Disease (COPD)

NCT03436511 | Completed

• 1 other identifier: 206555
• Study Type: observational
• Target: 341
• Locations: 1 country
• Sites: 4

Brief Summary

This observational study is designed to more specifically describe the burden of the disease and the use of healthcare resources of subjects with eosinophilic COPD that may be eligible in the future for a biologic treatment. Subjects who attend a routine follow-up visit and fulfill the inclusion/exclusion criteria defined provide a signed informed consent will be invited by the investigator to participate in this study. Subjects will be recruited in hospital Pulmonology Services across Spain. It is planned to include approximately 20 centers. To select the final participating centers, a feasibility study has been carried out in approximately 50 potential participating centers. It has been estimated that each investigator will include 18 subjects during the 4-month inclusion period. Total 354 subjects will be required: 250 subjects with an eosinophil level \>=150 cells per microliter and 104 subjects with an eosinophil level \<150 cells per microliter. The study inclusion period will be 4 months (expected to be from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Health resource utilization; Eosinophilic COPD; Mepolizumab

Outcome Measures

Primary Outcomes (8)

• Number of subjects requiring COPD maintenance treatment and rescue medication

  Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an inhaled corticosteroid (ICS) with a long-acting beta2-agonist (LABA) and with a long-acting muscarinic antagonist (LAMA) in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions along with rescue medication use will be analyzed.

  12 months prior to the inclusion visit

• Number of subjects with moderate and severe exacerbations

  Subjects who have experienced \>=2 moderate exacerbations or \>=1 severe exacerbation in the 12 months prior to the inclusion visit. Moderate exacerbation is defined as an exacerbation requiring antibiotics and/or oral corticosteroids or requiring an emergency visit \<24 hours (without hospitalization). Severe exacerbation is defined as an exacerbation requiring hospitalization.

  12 months prior to the inclusion visit

• Number of subjects with COPD-related scheduled and unscheduled primary and secondary care visits

  Subjects with COPD-related scheduled and unscheduled primary and secondary care visits will be analyzed.

  12 months prior to the inclusion visit

• Number of subjects with COPD-related emergency visits to primary care and hospital

  Subjects with COPD-related emergency visits to primary care and hospital will be analyzed.

  12 months prior to the inclusion visit

• Number of subjects with COPD-related hospitalizations

  Subjects with COPD-related hospitalizations will be analyzed.

  12 months prior to the inclusion visit

• Number of days of hospitalizations

  The number of days of hospitalization for subjects will be analyzed.

  12 months prior to the inclusion visit

• Number of subjects with COPD-related complementary tests

  Subjects with COPD-related complementary tests will be analyzed.

  12 months prior to the inclusion visit

• Number of subjects with COPD-related days-off work

  Subjects with COPD-related days-off work will be analyzed.

  12 months prior to the inclusion visit

Secondary Outcomes (8)

• Subjects age as a measure of sociodemographic characteristics

  4 months (inclusion period)

• Number of subjects with different gender

  4 months (inclusion period)

• Number of subjects with different sociodemographic variables

  4 months (inclusion period)

• Number of subjects with abnormal clinical variables

  4 months (inclusion period)

• Number of subjects with abnormal COPD related variables

  12 months prior to the inclusion visit

Study Arms (1)

Subjects with COPD

Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity \<70% recorded at any time in the medical record who have a qualifying peripheral blood eosinophil test recorded in the 3 months prior to the inclusion visit attend to a routine follow-up visit during the inclusion period, fulfill the inclusion/exclusion criteria and provide informed consent to participate, will be included in this study.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who attend a routine follow-up visit and who fulfill inclusion/exclusion criteria will be invited by the investigator to participate in the study. The study inclusion period will be four months (from November 2017 to March 2018) and the retrospective data collection period will be 12 months prior to the inclusion visit.

You may qualify if:

• Subjects of both sexes aged \>=40 years.
• Subjects with a COPD diagnosis confirmed with a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital capacity \<70% recorded at any time in the medical record.
• Subjects with a history of smoking (current or past) \>=10 pack-years.
• Subjects currently exposed to inhaled triple maintenance therapy, defined as at least one overlapping prescription of an ICS with a LABA and with a LAMA in 2 or 3 inhaler devices, without more than 30 days of separation between prescriptions.
• Subjects who consent to participate in the study by signing the subjects written informed consent form.

You may not qualify if:

• Subjects with a diagnosis of Churg-Strauss disease, hypereosinophilic syndrome, allergic bronchopulmonary aspergillosis or other conditions that result in increased eosinophil levels independently of COPD.
• Subjects with oncologic disease undergoing treatment or with advanced oncologic disease (without possibility of remission), terminal subjects and/or subjects receiving palliative care.
• Cognitively impaired subjects who are not able to understand or complete the informed consent and HRQoL questionnaires.

Sponsors & Collaborators

• GlaxoSmithKline: lead
• Oblikue Consulting: collaborator

Study Sites (4)

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Valencia, 46017, Spain

Location

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: December 5, 2017
• Primary Completion: October 31, 2018
• Study Completion: December 10, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

ES (4)