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Special Drug Use Investigation for ALLERMIST (Long Term)

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ClinicalTrials.gov Identifier: NCT01420822
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Rhinitis Drug: Fluticasone

Study Type : Observational
Actual Enrollment : 500 participants
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ALLERMIST (Long Term)
Study Start Date : December 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fluticasone
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects prescribed ALLERMIST
Subjects with allergic rhinitis prescribed ALLERMIST during study period
Drug: Fluticasone
Collection of safety data



Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420822


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01420822     History of Changes
Other Study ID Numbers: 113406
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents