Clinical trial NCT03219255: RELVAR® 100 ELLIPTA® Special Drug Use Investigation (COPD, Long-term)
Official title: Relvar 100 Ellipta Special Drug Use Investigation (COPD, Long-term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Post-marketing
Chronic obstructive pulmonary disease
Drug use investigation
RELVAR 100 ELLIPTA
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-07-17
Enrollment: 1047
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of subjects with adverse events (AEs), serious adverse events (SAEs) and drug related AEs
timeFrame: One year from the start of RELVAR treatment
measure: Number of subjects with pneumonia, systemic effects caused by corticosteroids and cardiovascular events
timeFrame: One year from the start of RELVAR treatment
measure: Efficacy rate based on global efficacy assessment
timeFrame: One year from the start of RELVAR treatment
measure: Time to COPD exacerbation
timeFrame: One year from the start of RELVAR treatment
measure: Change from Baseline in CAT score
timeFrame: Baseline and up to one year from the start of RELVAR treatment
measure: Change from Baseline in forced expiratory volume in 1 second (FEV1)
timeFrame: Baseline and up to one year from the start of RELVAR treatment
measure: Change from Baseline in forced vital capacity (FVC)
timeFrame: Baseline and up to one year from the start of RELVAR treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: GSK Investigational Site
city: Kanagawa
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: