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Drug Use Investigation for ALLERMIST

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ClinicalTrials.gov Identifier: NCT01376206
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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

Condition or disease Intervention/treatment
Rhinitis Drug: Fluticasone

Study Type : Observational
Actual Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Other
Official Title: Drug Use Investigation for ALLERMIST
Study Start Date : December 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : May 2011

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 adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray [ Time Frame: Four weeks ]


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:   Non-Probability Sample
Study Population
Subjects who have allergic rhinitis for which the indication of ALLERMIST has been approved and who are using ALLERMIST for the first time.
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 fluticason

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): NCT01376206


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376206     History of Changes
Other Study ID Numbers: 113407
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

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