Last updated: 02/03/2020 18:10:06
Drug Use Investigation of RELVAR® (vilanterol trifenatate and fluticasone furoate) for Asthma Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Drug Use Investigation of RELVAR® (vilanterol trifenatate and fluticasone furoate) for Asthma Patients
Trial description: This is a post-marketing surveillance (PMS) study conducted in Japan. The purpose of this investigation is to collect and evaluate information on the safety and effectiveness of vilanterol trifenatate and fluticasone furoate in routine clinical practice. RELVAR is a registered trademark of the GSK group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of adverse drug reactions and infections in routine clinical practice.
Timeframe: 12 weeks
Total scores of Athma Control Test
Timeframe: 12 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Vilanterol trifenatate and fluticasone furoate
Enrollment:
908
Observational study model:
Case-Only
Primary completion date:
2015-20-01
Time perspective:
Prospective
Clinical publications:
Junko Minami, Isao Mukai, Akihiro Kobayashi, Terufumi Hara,Hironori Sagara.Safety and Effectiveness of Vilanterol Trifenatate/Fluticasone Furoate Dry-Powder Inhaler (Relvar® Ellipta®) in Patients with Bronchial Asthma: Results of Drug Use Investigation.Ther Res.2015;36(5):455-467
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2013 to January 2015
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
none
- Patients with asthma
- Patients who are treated with vilanterol trifenatate and fluticasone furoate for the first time
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with asthma
- Patients who are treated with vilanterol trifenatate and fluticasone furoate for the first time
Exclusion criteria:
- None
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
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
2015-20-01
Actual study completion date
2015-20-01
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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