RELVAR® 100 ELLIPTA® Special Drug Use Investigation (COPD, Long-term)

NCT03219255 | Completed

• 1 other identifier: 205653
• Study Type: observational
• Target: 1,047
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to investigate the long-term safety and efficacy of RELVAR® 100 ELLIPTA® (hereinafter referred to as "Relvar") in daily clinical practice in subjects with chronic obstructive pulmonary disease (COPD), who are naive to RELVAR. A total of 1000 subjects, from approximately 200 medical institutions, will be registered for this study and 332 of them will be considered for safety analysis. In the investigation, subject registration and data collection will be conducted using an Electronic Data Capture (EDC) system. Post-registration, the investigator will monitor the information regarding the safety and efficacy of RELVAR for one year from the start date of treatment with RELVAR. Pneumonia, systemic effects caused by corticosteroids and cardiovascular events will be considered as the priority investigation matters. At the end of observation period, the investigator will enter the obtained information into the EDC system and submit it. RELVAR 100 ELLIPTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Post-marketing; Chronic obstructive pulmonary disease; Drug use investigation; RELVAR 100 ELLIPTA

Outcome Measures

Primary Outcomes (7)

• Number of subjects with adverse events (AEs), serious adverse events (SAEs) and drug related AEs

  The investigator will collect the information about all AEs (e.g., a disease, symptom, abnormal laboratory value) occurring after the start of RELVAR administration, regardless of whether or not RELVAR is related to an AE. The AEs assessed as 'related' to RELVAR will be handled as adverse drug reactions (ADRs).

  One year from the start of RELVAR treatment

• Number of subjects with pneumonia, systemic effects caused by corticosteroids and cardiovascular events

  Pneumonia, systemic effects such as suppression of adrenal cortical function, bone disorders, eye disorders, etc. caused by corticosteroids and cardiovascular events will be considered as priority investigation matter for this investigation and its occurrence will be monitored throughout the study period.

  One year from the start of RELVAR treatment

• Efficacy rate based on global efficacy assessment

  The efficacy rate is the proportion of subjects assessed as "effective." Efficacy will be globally assessed based on the courses of subjective and clinical symptoms, COPD exacerbation, changes in values for respiratory function tests, change in COPD assessment test (CAT) scores, etc. during the period between the start date of treatment and the end of the observation period.

  One year from the start of RELVAR treatment

• Time to COPD exacerbation

  The COPD exacerbations are episodes, which may refer to an increase in the severity of disease or its sign and symptoms. The presence or absence of exacerbation for one year before and after the start of treatment with RELVAR (or at the time of withdrawal/ termination), presence or absence of hospitalization, treatment with antimicrobial agents and/or systemic steroids and exacerbation not corresponding to the above-mentioned parameters in each exacerbation episode will be determined.

  One year from the start of RELVAR treatment

• Change from Baseline in CAT score

  The CAT is a questionnaire designed to measure the impact of COPD on subject's life and how it changes over time. Investigator will record the information of CAT completed by subjects at the start of treatment with RELVAR, Month 3 and Year 1 or at the time of withdrawal/termination.

  Baseline and up to one year from the start of RELVAR treatment

• Change from Baseline in forced expiratory volume in 1 second (FEV1)

  Respiratory function test will be performed by spirometry. Information regarding presence or absence of tests, date of tests, presence or absence of short-acting Beta-2 agonists within four hours before measurement, and FEV1 at the start of treatment with RELVAR, Month 3 and Year 1 or at the time of withdrawal/termination will be collected.

  Baseline and up to one year from the start of RELVAR treatment

• Change from Baseline in forced vital capacity (FVC)

  Respiratory function test will be performed by spirometry. Information regarding presence or absence of tests, date of tests, presence or absence of short-acting Beta-2 agonists within four hours before measurement, and FVC at the start of treatment with RELVAR, Month 3 and Year 1 or at the time of withdrawal/termination will be collected.

  Baseline and up to one year from the start of RELVAR treatment

Study Arms (1)

Subjects receiving RELVAR 100 ELLIPTA

Subjects with a diagnosis of COPD, for which RELVAR is indicated, who are naive to RELVAR will be included.

Drug: RELVAR 100 ELLIPTA

Interventions

RELVAR 100 ELLIPTA DRUG

RELVAR 100 ELLIPTA contains fluticasone furoate, an inhaled corticosteroid and vilanterol, an ultra-long-acting Beta-2 agonist and it is indicated for the treatment of COPD (bronchitis chronic/emphysema). Post-marketing investigation of RELVAR 100 ELLIPTA will be carried out in this analysis.

Subjects receiving RELVAR 100 ELLIPTA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will assess and collect the information about safety and effectiveness of RELVAR in approximately 1000 subjects with COPD (bronchitis chronic/emphysema), for which RELVAR is indicated, who are naïve to RELVAR.

You may qualify if:

• Subjects with a diagnosis of COPD (bronchitis chronic/emphysema) and who are naive to RELVAR will be included.

You may not qualify if:

• Among subjects with concomitant asthma, subjects with experience of taking RELVAR for treatment of asthma will be excluded from the investigation.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Hokkaido, 003-0825, Japan

Location

GSK Investigational Site

Kanagawa, 211-0025, Japan

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

Study Design

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

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: July 17, 2017
• Study Start: August 30, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: July 27, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)