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
  Purpose

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


Condition Intervention
Rhinitis, Allergic, Perennial and Seasonal
Drug: fluticasone furoate group

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of participants with an adverse event [ Time Frame: 2weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 3000
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fluticasone furoate group
Korean patients administered fluticasone furoate according to the Prescription information
Drug: fluticasone furoate group
patients who are administered fluticasone furoate at least once
Other Name: according to label and physician's decision

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients administrated Avamys at the site

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001130

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
Korea, Republic of
GSK Investigational Site Recruiting
Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01001130     History of Changes
Other Study ID Numbers: 113596
Study First Received: October 22, 2009
Last Updated: November 14, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
avamys
Allergic Rhinitis
post marketing surveillance
Seasonal Allergic Rhinitis
Perennial Allergic Rhinitis (PAR)
rhinitis

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 14, 2014