Regulatory AVAMYS Nasal Spray PMS

GlaxoSmithKline3,244 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

3,244

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Interventions

fluticasone furoate groupDRUG

patients who are administered fluticasone furoate at least once

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

Number of participants with an adverse event

Time frame: 2 weeks

Secondary Outcomes

Number of participants with a serious adverse event

Time frame: 2 weeks

Number of participants with an unexpected or expected adverse drug reaction

Time frame: 2 weeks

Effectiveness after AVAMYS nasal spray administration

Time frame: 2 weeks

Data from ClinicalTrials.gov

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