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
Study complete
Study complete
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
    Primary completion date:
    2021-30-03
    Observational study model:
    Cohort
    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
    Study complete
    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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