Regulatory AVAMYS Nasal Spray PMS

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rhinitis, Allergic, Perennial and Seasonal

Intervention / Treatment
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* Drug: fluticasone furoate group


Participation Criteria
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Eligibility Criteria
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All subjects must satisfy the following criteria. Subject who is treated with AVAMYS nasal spray for the first time. Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years. Subject who is considered to follow the PMS protocol by an investigator. Subject who is contactable via telephone. 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. Subject who has hypersensitivity to its ingredients. 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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fluticasone furoate group<br>Korean patients administered fluticasone furoate according to the Prescription information | Drug: fluticasone furoate group<br>* patients who are administered fluticasone furoate at least once<br>* Other names: according to label and physician's decision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with an adverse event | Number of participants with an adverse event | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a serious adverse event | Number of participants with a serious adverse event | 2 weeks | 
| Number of participants with an unexpected or expected adverse drug reaction | Number of participants with an unexpected or expected adverse drug reaction | 2 weeks | 
| Effectiveness after AVAMYS nasal spray administration | Effectiveness after AVAMYS nasal spray administration | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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avamys, Allergic Rhinitis, post marketing surveillance, Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis (PAR)