Not Signed In -
Seasonal Affective Disorder (SAD) |
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Clinical Trial: Study in Adolescent and Adult Subjects 12 Years of Age and Older with Seasonal Allergic Rhinitis
This study is currently recruiting patients.
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Purpose
Allergic rhinitis is an inflammatory disorder of the upper airway that occurs following allergen exposure. The focus of this study, seasonal allergic rhinitis (SAR), is one type of allergic rhinitis that is triggered by the pollen from trees, grasses, and weeds. Commonly referred to as hayfever, it is characterized by sneezing, nasal congestion and pruritus, rhinorrhea, and pruritic, watery, red eyes. The purpose of the study is to evaluate the onset of action of an investigational nasal spray in the treatment of seasonal allergic rhinitis.
| Condition | Intervention | Phase |
|---|---|---|
| Rhinitis, Allergic, Seasonal | Drug: GW685698X Aqueous Nasal Spray | Phase III |
MedlinePlus related topics: Allergy
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double Blind, Placebo-Controlled, Single-Dose, Parallel-Group Study to Evaluate the Onset of Action of a Single Dose of Intranasal GW685698X Aqueous Nasal Spray 100 Mcg in Adolescent and Adult Subjects (≥12 Years of Age) with Seasonal Allergic Rhinitis Exposed to Ragweed Pollen in an Allergen Challenge Chamber
Further Study Details:
Expected Total Enrollment: 380
Study start: April 2005
Eligibility
Ages Eligible for Study: 12 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
- Informed consent
- Outpatient
- Females must use appropriate contraception
- Diagnosis of seasonal allergic rhinitis
- Able to comply with study procedures
- Literate
Exclusion criteria:
- Significant concomitant medical condition
- Use of corticosteroids, allergy medications, or tobacco
- Clinically significant abnormal ECG
- Laboratory abnormality
- Positive pregnancy test
- Allergy to any component of investigational product
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00118729
Georgia
Robert Berkowitz, Atlanta, Georgia, 30188, United States; Recruiting
Robert Berkowitz 770-592-4210
Study chairs or principal investigators
GSK Clinical Trials, Study Director, GlaxoSmithKline
More Information
Study ID Numbers: FFR101816
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 11, 2005
ClinicalTrials.gov Identifier: NCT00118729
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
Record last reviewed: July 2005
Last Updated: July 25, 2005
Record first received: July 11, 2005
ClinicalTrials.gov Identifier: NCT00118729
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-26
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