Rhinitis, Allergic, Perennial and Seasonal
Conditions
Keywords
avamys, Allergic Rhinitis, post marketing surveillance, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis (PAR)
Brief summary
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.
Interventions
DRUGfluticasone furoate group
patients who are administered fluticasone furoate at least once
Sponsors
GlaxoSmithKline
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with an adverse event | 2 weeks | Number of participants with an adverse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a serious adverse event | 2 weeks | Number of participants with a serious adverse event |
| Number of participants with an unexpected or expected adverse drug reaction | 2 weeks | Number of participants with an unexpected or expected adverse drug reaction |
| Effectiveness after AVAMYS nasal spray administration | 2 weeks | Effectiveness after AVAMYS nasal spray administration |
Countries
South Korea
Outcome results
None listed