Last updated: 11/07/2018 06:04:31
Special Drug Use Investigation for ALLERMIST (Long term)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for ALLERMIST (Long term)
Trial description: This post-marketing surveillance study is to investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with allergic rhinitis under the conditions of actual practical use.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use
Timeframe: One year
Efficacy evaluation based on the subjective/objective symptom progresses in the period from the start of Allermist treatment to the end of the observation period
Timeframe: One year
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone
Enrollment:
500
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Yanagita,Y; Nakano,N; Hara,T; Yoshida,P . Long-term Safety and Effectiveness of Fluticasone Furoate (Allermist®) Nasal Spray in Patients with Perennial Allergic Rhinitis: Results of Special Drug Use Investigation. J Clin Therapeut Med. 2015;31(11):
Medical condition
Rhinitis
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
December 2010 to August 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- Diagnosis of allergic rhinitis
- Use ALLERMIST for the first time
- Subjects with infection which fluticasone is not effective
- Subjects with deep mycosis
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosis of allergic rhinitis
- Use ALLERMIST for the first time
- Expected to use ALLERMIST for long-term (1 year).
Exclusion criteria:
- Subjects with infection which fluticasone is not effective
- Subjects with deep mycosis
- Subjects with hypersensitivity to fluticasone
Trial location(s)
No location data available.
Study documents
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
Not applicable
Actual study completion date
2014-29-08
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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