Regulatory AVAMYS Nasal Spray PMS

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001130
• Other study ID #: 113596
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: June 26, 2014
• Start date: May 2010
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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 prescribing information.

AVAMYS is a registered trademark of the GSK group of companies.

Recruitment information / eligibility

• 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Perennial
• Rhinitis, Allergic, Perennial and Seasonal

Intervention

Drug:
• fluticasone furoate group
patients who are administered fluticasone furoate at least once

Locations

Country	Name	City	State
Korea, Republic of	GSK Investigational Site	Seongnam-si Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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