Status:
COMPLETED
Regulatory AVAMYS Nasal Spray PMS
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rhinitis, Allergic, Perennial and Seasonal
Eligibility:
All Genders
2+ years
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 pr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
3244 Patients enrolled
Trial Details
Trial ID
NCT01001130
Start Date
May 1 2010
End Date
May 1 2014
Last Update
June 30 2014
Active Locations (1)
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1
GSK Investigational Site
Seongnam-si Gyeonggi-do, South Korea, 463-707