Regulatory AVAMYS Nasal Spray PMS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01001130
First received: October 22, 2009
Last updated: June 26, 2014
Last verified: June 2014

October 22, 2009
June 26, 2014
May 2010
May 2014   (final data collection date for primary outcome measure)
Number of participants with an adverse event [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Number of participants with an adverse event
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: 2 weeks ] [ Designated as safety issue: No ]
    Number of participants with a serious adverse event
  • Number of participants with an unexpected or expected adverse drug reaction [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Number of participants with an unexpected or expected adverse drug reaction
  • Effectiveness after AVAMYS nasal spray administration [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Effectiveness after AVAMYS nasal spray administration
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 Nasal Spray 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 nasal spray administered in Korean patients according to the prescribing information.

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

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

Patients administrated AVAMYS nasal spray 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.
 
Completed
3244
May 2014
May 2014   (final data collection date for primary outcome measure)

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.
Both
2 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01001130
113596
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2014

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