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OpenTrials
Completed

NCT Number: NCT01001130

Regulatory AVAMYS Nasal Spray PMS

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.

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Key information

Conditions

Rhinitis, Allergic, Perennial and Seasonal Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial Rhinitis, Allergic, Seasonal

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Seongnam-si Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fluticasone furoate group

Drug

patients who are administered fluticasone furoate at least once

Other names: according to label and physician's decision

Primary outcomes

  1. Number of participants with an adverse event

    Time frame: 2 weeks

    Number of participants with an adverse event

Secondary outcomes

  1. Number of participants with a serious adverse event

    Time frame: 2 weeks

    Number of participants with a serious adverse event

  2. Number of participants with an unexpected or expected adverse drug reaction

    Time frame: 2 weeks

    Number of participants with an unexpected or expected adverse drug reaction

  3. Effectiveness after AVAMYS nasal spray administration

    Time frame: 2 weeks

    Effectiveness after AVAMYS nasal spray administration

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 23, 2009
Registry last updated
Jun 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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