Last updated: 09/01/2022 05:30:10
RELVAR® 100 ELLIPTA® Special Drug Use Investigation (COPD, Long-term)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
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:
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
- 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.
Inclusion and exclusion 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.
Trial location(s)
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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