Last updated: 11/07/2018 06:27:03
Regulatory AVAMYS nasal spray PMS
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Avamys® administered in Korean patients according to the prescribing information
Trial description: Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of AVAMYS nasal spray administered in Korean patients according to the prescribing information.AVAMYS 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:
Number of participants with an adverse event
Timeframe: 2 weeks
Secondary outcomes:
Number of participants with a serious adverse event
Timeframe: 2 weeks
Number of participants with an unexpected or expected adverse drug reaction
Timeframe: 2 weeks
Effectiveness after AVAMYS nasal spray administration
Timeframe: 2 weeks
Interventions:
Drug: fluticasone furoate group
Enrollment:
3244
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Cho, J; Min,S; Lee,Y. A Post-marketing Surveillance to Evaluate the Safety of Fluticasone furoate nasal spray in Korean with seasonal and perennial allergic rhinitis. JPERM. 2017;9(1):16-22
Medical condition
Rhinitis, Allergic, Perennial and Seasonal
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
May 2010 to May 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
2+ years
Accepts healthy volunteers
No
- All subjects must satisfy the following criteria.
- 1. Subject who is treated with AVAMYS nasal spray for the first time.
Inclusion and exclusion criteria
Inclusion criteria:
- All subjects must satisfy the following criteria. 1. Subject who is treated with AVAMYS nasal spray for the first time. 2. Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years. 3. Subject who is considered to follow the PMS protocol by an investigator. 4. Subject who is contactable via telephone. 5. Subject who is treated with AVAMYS nasal spray according to its prescribing information. As considering the characteristic of the observational post marketing surveillance, the exclusion criteria is not strict. All investigators should prescribe AVAMYS nasal spray according to prescribing information which approved in Korea. All subjects must not satisfy the following criteria. 1. Subject who has hypersensitivity to its ingredients. 2. As corticosteroids can slow the healing of wounds, if a subject who has surgery on his/her nose recently, or has a sore in his/her nose, or if his/her nose has been injured, the subject does not use AVAMYS nasal spray until his/her nose has healed.
Trial location(s)
Location
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 463-707
Status
Study Complete
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
2014-13-05
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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