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

Status

Completed

Intervention / Treatment

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

        • GSK Investigational Site

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
Adverse events and laboratory blood test

Secondary Outcome Measures

Outcome Measure
Change of nasal symptom score

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

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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