- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00358475
Study Of Perennial Allergic Rhinitis
August 30, 2018 updated by: GlaxoSmithKline
Study of Perennial Allergic Rhinitis -Long Term Treatment Study-
This study was designed to assess safety of an investigational nasal spray in the treatment of perennial allergic rhinitis.
Perennial allergic rhinitis is triggered by house dust, mite and mold etc.
Typical symptoms are sneezing, nasal congestion and pruritus and rhinorrhea.
Study Overview
Study Type
Interventional
Enrollment (Actual)
65
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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- GSK Investigational Site
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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
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Informed consent.
- Outpatient.
- Diagnosis of perennial allergic rhinitis with symptoms.
- Able to comply with study procedures.
Exclusion criteria:
- Significant concomitant medical condition.
- Use of corticosteroids/allergy medications.
- Laboratory abnormality.
- Positive pregnancy test.
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
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Adverse events and laboratory blood test
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Secondary Outcome Measures
Outcome Measure |
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Change of nasal symptom score
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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
June 21, 2005
Primary Completion (Actual)
October 1, 2005
Study Completion (Actual)
October 12, 2005
Study Registration Dates
First Submitted
July 27, 2006
First Submitted That Met QC Criteria
July 27, 2006
First Posted (Estimate)
July 31, 2006
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 30, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FFR100688
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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