Last updated: 09/01/2022 05:30:10

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

GSK study ID
205653
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Relvar 100 Ellipta Special Drug Use Investigation (COPD, Long-term)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

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

Timeframe: One year from the start of RELVAR treatment

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

Timeframe: One year from the start of RELVAR treatment

Efficacy rate based on global efficacy assessment

Timeframe: One year from the start of RELVAR treatment

Time to COPD exacerbation

Timeframe: One year from the start of RELVAR treatment

Change from Baseline in CAT score

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

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

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

Change from Baseline in forced vital capacity (FVC)

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

Secondary outcomes:
Not applicable
Interventions:
Drug: RELVAR 100 ELLIPTA
Enrollment:
1047
Observational study model:
Cohort
Primary completion date:
2021-30-03
Time perspective:
Prospective
Clinical publications:
Kanae Sakata; Shigeomi Iimura; Yukiko Yanagita; Kiyomi Aizawa; Takeo Ishii; Naohiro Takahashi. Evaluation of Long-term Safety and Effectiveness of Vilanterol/Fluticasone Furoate Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease (COPD) in Routine Clinical Practice - Report of Special Drug Use Investigation Results. Ther Res. 2022;43(7):585-599 DOI: NULL PMID: NULL
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
August 2017 to March 2021
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
  • Subjects with a diagnosis of COPD (bronchitis chronic/emphysema) and who are naive to RELVAR will be included.
  • Among subjects with concomitant asthma, subjects with experience of taking RELVAR for treatment of asthma will be excluded from the investigation.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Hokkaido, Japan, 003-0825
Status
Study Complete
Location
GSK Investigational Site
Kanagawa, Japan, 211-0025
Status
Study Complete

Study documents

Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Finalized
Actual primary completion date
2021-30-03
Actual study completion date
2021-30-03

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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