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
  Purpose

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.


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: 2 weeks ] [ Designated as safety issue: No ]
    Number of participants with an adverse event


Secondary Outcome Measures:
  • 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


Enrollment: 3244
Study Start Date: May 2010
Study Completion Date: May 2014
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 nasal spray at the site

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
GSK Investigational Site
Seongnam-si Gyeonggi-do, Korea, Republic of, 463-707
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: June 26, 2014
Health Authority: Korea: Food and Drug Administration

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

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 July 23, 2014