Special Drug Use Investigation for ALLERMIST (Long Term)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01420822
First received: June 2, 2011
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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 Intervention
Rhinitis
Drug: Fluticasone

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ALLERMIST (Long Term)

Further study details as provided by GlaxoSmithKline:

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: 500
Study Start Date: December 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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

Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420822

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01420822     History of Changes
Other Study ID Numbers: 113406
Study First Received: June 2, 2011
Last Updated: July 17, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on September 18, 2014