Regulatory AVAMYS Nasal Spray PMS

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Rhinitis, Allergic, Perennial and Seasonal

Treatments: Drug: fluticasone furoate group

Study type: Observational

Funder types: Industry

Identifiers

NCT01001130

113596

Details and patient eligibility

About

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.

Enrollment: 3,244 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

3,244 participants in 1 patient group

fluticasone furoate group

Description:

Korean patients administered fluticasone furoate according to the Prescription information

Treatment:

Drug: fluticasone furoate group