- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420822
Special Drug Use Investigation for ALLERMIST (Long Term)
March 26, 2015 updated by: GlaxoSmithKline
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
500
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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).
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects prescribed ALLERMIST
Subjects with allergic rhinitis prescribed ALLERMIST during study period
|
Collection of safety data
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of incidence of adverse events in Japanese subjects treated with ALLERMIST Nasal Spray for long-term use
Time Frame: One year
|
One year
|
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
|
One year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
August 1, 2014
Study Completion (ACTUAL)
August 1, 2014
Study Registration Dates
First Submitted
June 2, 2011
First Submitted That Met QC Criteria
August 18, 2011
First Posted (ESTIMATE)
August 22, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 27, 2015
Last Update Submitted That Met QC Criteria
March 26, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Otorhinolaryngologic Diseases
- Nose Diseases
- Rhinitis
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
Other Study ID Numbers
- 113406
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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