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OpenTrials
Completed

NCT Number: NCT01420822

Special Drug Use Investigation for ALLERMIST (Long Term)

This post-marketing surveillance study is to investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray for long-term use in Japanese subjects with allergic rhinitis under the conditions of actual practical use.

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Key information

Conditions

Rhinitis Infections Nose Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of allergic rhinitis
  • Use ALLERMIST for the first time
  • Expected to use ALLERMIST for long-term (1 year).

Exclusion criteria

  • Subjects with infection which fluticasone is not effective
  • Subjects with deep mycosis
  • Subjects with hypersensitivity to fluticasone

Treatment and study plan

Fluticasone

Drug

Collection of safety data

Primary outcomes

  1. The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use

    Time frame: One year

  2. Efficacy evaluation based on the subjective/objective symptom progresses in the period from the start of Allermist treatment to the end of the observation period

    Time frame: One year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 22, 2011
Registry last updated
Mar 27, 2015

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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