Last updated: 07/31/2020 14:30:05
Special Drug Use Investigation of ALLERMIST Nasal Spray in Pediatric Patients
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation of ALLERMIST Nasal Spray in Pediatric Patients
Trial description: This post-marketing surveillance(PMS)study is conducted to collect safety and effectiveness data in pediatric patients with allergic rhinitis who are treated with fluticasone nasal spray for the first time. ALLERMIST 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:
The incidence of adverse drug reactions
Timeframe: 24 weeks
Secondary outcomes:
Not applicable
Interventions:
Drug: Fluticasone nasal spray
Enrollment:
1000
Observational study model:
Case-Only
Primary completion date:
2017-31-10
Time perspective:
Prospective
Clinical publications:
Yasuyo Nose, Yoshifumi Inagaki,Hirohiko Murayama,Kiyomi Aizawa,Terufumi Hara,Wataru Sugiura. Safety and efficacy evaluation of fluticasone furoate (ALLERMIST) nasal spray in pediatric patients with allergic rhinitis Special drug use investigation results. Jpn J Pediatr. 2018;71(11):109-121
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
October 2014 to October 2017
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
- 15 Years
Accepts healthy volunteers
Not applicable
- Inclusion Criteria
- Subjects with allergic rhinitis
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Subjects with allergic rhinitis
- Subjects who are treated with fluticasone nasal spray for the first time
- Subjects who are under 15 years of age Exclusion Criteria
- none
Trial location(s)
No location data available.
Study documents
Clinical study report
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
Finalized
Actual primary completion date
2017-31-10
Actual study completion date
2017-31-10
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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