Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis

Launched by WESTERN SKY MEDICAL RESEARCH · Oct 16, 2009

Keywords

ClinConnect Summary

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 weekly as measured by a validated test of cognitive performance (TOVA). The treatment group with intervention of fluticasone furoate nasal spray 110 mcg two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.