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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: RELVAR 100 ELLIPTA

• Registration Number: NCT03219255
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-07-07
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-17
• Study Start: 2017-08-30
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1047

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects receiving RELVAR 100 ELLIPTA	RELVAR 100 ELLIPTA	Subjects with a diagnosis of COPD, for which RELVAR is indicated, who are naive to RELVAR will be included.

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events (AEs), serious adverse events (SAEs) and drug related AEs	One year from the start of RELVAR treatment	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).
Change from Baseline in CAT score	Baseline and up to one year from the start of RELVAR treatment	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.
Number of subjects with pneumonia, systemic effects caused by corticosteroids and cardiovascular events	One year from the start of RELVAR treatment	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.
Efficacy rate based on global efficacy assessment	One year from the start of RELVAR treatment	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.
Time to COPD exacerbation	One year from the start of RELVAR treatment	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.
Change from Baseline in forced vital capacity (FVC)	Baseline and up to one year from the start of RELVAR treatment	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.
Change from Baseline in forced expiratory volume in 1 second (FEV1)	Baseline and up to one year from the start of RELVAR treatment	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Kanagawa, Japan