Special Drug Use Investigation for ALLERMIST (Long Term)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by GlaxoSmithKline.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01420822
First received: June 2, 2011
Last updated: June 6, 2013
Last verified: August 2011
  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)

Resource links provided by NLM:


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: Yes ]
  • 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: Yes ]

Estimated Enrollment: 500
Study Start Date: December 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (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
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 fluticason
  Contacts and Locations
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: June 6, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on April 16, 2014