Regulatory AVAMYS Nasal Spray PMS | NCT01001130

Studies
Regulatory AVAMYS Nasal Spray PMS

NCT01001130

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Jun 30, 2014Estimated

Enrollment

3,244Actual

Phase

Not provided

Conditions

Rhinitis, Allergic, Perennial and Seasonal

Interventions

fluticasone furoate group

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Oct 22, 2009

First Submission Date that Met QC Criteria

Oct 22, 2009

First Posted Date

Oct 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2014

Last Update Posted Date

Jun 30, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,244Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fluticasone furoate group		Korean patients administered fluticasone furoate according to the Prescription information	Drug: fluticasone furoate group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fluticasone furoate group	Drug	patients who are administered fluticasone furoate at least once	fluticasone furoate group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with an adverse event	Number of participants with an adverse event	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with a serious adverse event	Number of participants with a serious adverse event	2 weeks
Number of participants with an unexpected or expected adverse drug reaction	Number of participants with an unexpected or expected adverse drug reaction

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

All subjects must satisfy the following criteria.

Subject who is treated with AVAMYS nasal spray for the first time.
Subject who is treated due to symptoms of seasonal and perennial allergic rhinitis in adults and children ≥2 years.
Subject who is considered to follow the PMS protocol by an investigator.
Subject who is contactable via telephone.
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.

Subject who has hypersensitivity to its ingredients.
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients administrated AVAMYS nasal spray at the site

Sampling Method

Probability Sample

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Seongnam-si Gyeonggi-do		463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012220	Rhinitis
D065631	Rhinitis, Allergic
D006255	Rhinitis, Allergic, Seasonal
D012221	Rhinitis, Allergic, Perennial

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided