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Drug Use Investigation for ALLERMIST

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376206
First Posted: June 20, 2011
Last Update Posted: May 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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 Intervention
Rhinitis Drug: Fluticasone

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: Drug Use Investigation for ALLERMIST

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of adverse events in Japanese subjects with allergic rhinitis treated with fluticasone nasal spray [ Time Frame: Four weeks ]

Enrollment: 2000
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed ALLERMIST
Subjects with allergic rhinitis prescribed ALLERMIST during study period
Drug: Fluticasone
Collection of safety data

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376206     History of Changes
Other Study ID Numbers: 113407
First Submitted: June 9, 2011
First Posted: June 20, 2011
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


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