Status:
COMPLETED
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Lead Sponsor:
Western Sky Medical Research
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The hypothesis is that treating hay fever patients who had daytime sleepiness and slowed thinking because of the hay fever will improve when treated with an effective anti-hay fever medication, an int...
Detailed Description
In this study of patients with seasonal allergic rhinitis we will monitor daytime sleepiness as measured by validated daytime sleep score (Eppworth Daytime Sleepiness Scale) and cognitive performance ...
Eligibility Criteria
Inclusion
- Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time of study in the season of the study.
- Allergy skin tests positive for the airborne allergens present at the study time within the past 12 months.
- A score of 2 or more on the NRQLQ of the Rhinitis Quality of LIfe Questionnaire.
- Active allergic rhinitis on 4 of 7 days during run-in week, and evidence on sleep scales of drowsiness on 3 of 7 days.
- Ability to read, understand and give informed consent.
- Ability to understand and carry out responsibilities of the study
Exclusion
- Any chronic disease or other acute disease, which could influence central nervous system.
- The use of any medication, which could affect central nervous system function.
- Unwillingness to participate in the study.
- Inability to understand testing procedures or use of medication.
- Hypersensitivity to fluticasone or vehicle of nasal sprays.
- Any sleep disorders including obstructive sleep apnea.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00997620
Start Date
March 1 2010
End Date
October 1 2010
Last Update
May 18 2018
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