Drug Use Investigation for ALLERMIST

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376206
First received: June 9, 2011
Last updated: June 16, 2011
Last verified: June 2011

June 9, 2011
June 16, 2011
December 2009
September 2010   (final data collection date for primary outcome measure)
The number of adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray [ Time Frame: Four weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01376206 on ClinicalTrials.gov Archive Site
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Drug Use Investigation for ALLERMIST
Drug Use Investigation for ALLERMIST

To investigate possible problems or questions in safety and efficacy of ALLERMIST Nasal Spray in Japanese subjects with allergic rhinitis under the practical use conditions

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Observational
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Non-Probability Sample

Subjects who have allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time.

Rhinitis
Drug: Fluticasone
Collection of safety data
Subjects prescribed ALLERMIST
Subjects with allergic rhinitis prescribed ALLERMIST during study period
Intervention: Drug: Fluticasone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2000
May 2011
September 2010   (final data collection date for primary outcome measure)

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 fluticason
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01376206
113407
No
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP