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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01001130
Other study ID # 113596
Secondary ID
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


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
See also
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