Rhinitis, Allergic, Perennial and Seasonal Clinical Trial
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
Verified date | June 2014 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Observational |
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.
Status | Completed |
Enrollment | 3244 |
Est. completion date | May 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 2 Years and older |
Eligibility |
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. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | GSK Investigational Site | Seongnam-si Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with an adverse event | Number of participants with an adverse event | 2 weeks | No |
Secondary | Number of participants with a serious adverse event | Number of participants with a serious adverse event | 2 weeks | No |
Secondary | Number of participants with an unexpected or expected adverse drug reaction | Number of participants with an unexpected or expected adverse drug reaction | 2 weeks | No |
Secondary | Effectiveness after AVAMYS nasal spray administration | Effectiveness after AVAMYS nasal spray administration | 2 weeks | No |
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