Special Drug Use Investigation for ALLERMIST (Long Term)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: June 2, 2011
Last updated: July 17, 2014
Last verified: July 2014
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.
||Time Perspective: Prospective
||Special Drug Use Investigation for ALLERMIST (Long Term)
Primary Outcome Measures:
- The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use [ Time Frame: One year ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Subjects prescribed ALLERMIST
Subjects with allergic rhinitis prescribed ALLERMIST during study period
Collection of safety data
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
The target subjects shall be those who with allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time and also who are expected to use ALLERMIST for long-term (1 year).
- Diagnosis of allergic rhinitis
- Use ALLERMIST for the first time
- Expected to use ALLERMIST for long-term (1 year).
- Subjects with infection which fluticasone is not effective
- Subjects with deep mycosis
- Subjects with hypersensitivity to fluticasone
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01420822
||GSK Clinical Trials
No publications provided
ClinicalTrials.gov processed this record on November 19, 2014
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 2, 2011
||July 17, 2014
||Japan: Pharmaceuticals and Medical Devices Agency