Last updated: 02/15/2019 19:40:47
Special Drug Use Investigation of RELVAR® for Asthma patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Special Drug Use Investigation of RELVAR® 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 assess information on the safety and effectiveness for long-term use 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: 1 year
Total scores of Athma Control Test
Timeframe: 1 year
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
1240
Primary completion date:
2018-29-03
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Hironori Sagara, Junko Minami, Naho Oyanagi, Isao Mukai, Akihiro Kobayashi, Terufumi Hara. Safety and effectiveness of vilanterol trifenatate / fluticasone furoate dry powder inhaler in patients with bronchial asthma in clinical practice: A report of 1-year special drug use investigation. Ther Res. 2018;39(11):935-952
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/vilanterol, vilanterol
Collaborators
Not applicable
Study date(s)
September 2014 to March 2018
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, and expected for long-term use.
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Patients with asthma
- Patients who are treated with vilanterol trifenatate and fluticasone furoate for the first time, and expected for long-term use.
Exclusion criteria:
- None
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
Clinical study report
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
2018-29-03
Actual study completion date
2018-29-03
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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