Regulatory Avamys PMS

This study is currently recruiting participants.
Verified January 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01001130
First received: October 22, 2009
Last updated: November 14, 2013
Last verified: January 2013

October 22, 2009
November 14, 2013
May 2010
May 2014   (final data collection date for primary outcome measure)
Number of participants with an adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
The primary objective of this PMS is to investigate adverse events of AVAMYS® Nasal Spray(NS) in Korean patients with SAR or PAR [ Time Frame: Every adverse event which occur after visit 1 will be collected ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01001130 on ClinicalTrials.gov Archive Site
  • Number of participants with a serious adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
  • Number of participants with an unexpected adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]
The secondary objectives are to identify any unexpected adverse events and serious adverse events, and to evaluate efficacy after AVAMYS® NS administration in Korean patients with SAR or PAR. [ Time Frame: Every adverse event which occur after Visit 1 will be collected ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Regulatory Avamys PMS
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

Non-interventional, open-label, single group, multicentric post-marketing surveillance to monitor the safety and effectiveness of Avamys® administered in Korean patients according to the prescribing information

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients administrated Avamys at the site

Rhinitis, Allergic, Perennial and Seasonal
Drug: fluticasone furoate group
patients who are administered fluticasone furoate at least once
Other Name: according to label and physician's decision
fluticasone furoate group
Korean patients administered fluticasone furoate according to the Prescription information
Intervention: Drug: fluticasone furoate group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
May 2014
May 2014   (final data collection date for primary outcome measure)

All subjects must satisfy the following criteria at PMS entry according to KFDA PMS regulation:

  • Subjects with indication in the prescribing information
  • Subjects administrated Avamys® by physician's decision
  • Subjects with no contraindication according to the prescribing information
Both
2 Years and older
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Korea, Republic of
 
NCT01001130
113596
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP