Clinical trial NCT00997620: Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Official title: A Double Blind, Placebo Controlled Randomized Trial Evaluating the Effects of Fluticasone Nasal Spray in Subjects With Seasonal Allergic Rhinitis and a History of Sleep Disturbance on Cognitive Performance and Daytime Sleepiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: Hay Fever
Daytime somnolence
Cognition
Lead sponsor: Western Sky Medical Research
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-10-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 intranasal steroid, that is will have less daytime sleepiness and demonstrate better thinking.

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 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.

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.

Primary outcomes:
measure: Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance
timeFrame: over 2 weeks
measure: Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.
timeFrame: after 2 weeks intervention
measure: Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.
timeFrame: over 2 weeks
Secondary outcomes:
measure: Change in Epworth Sleep Scale
timeFrame: Baseline and after 2 weeks intervention
measure: Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire
timeFrame: 2 weeks
measure: Nasal Symptom Scores
timeFrame: 2 weeks
Other outcomes:
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