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

Western Sky Medical Research

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Fluticasone furoate Nasal Spray 110 mcg; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00997620

2008-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis.

Treatment:

Drug: Placebo

Fluticasone Furoate

Experimental group

Description:

IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis

Treatment:

Drug: Fluticasone furoate Nasal Spray 110 mcg