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

Last updated: May 14, 2018
Sponsor: Western Sky Medical Research
Overall Status: Completed

Phase

4

Condition

Common Cold

Allergy

Rhinitis, Allergic, Perennial

Treatment

N/A

Clinical Study ID

NCT00997620
2008-4
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Symptomatic seasonal allergic rhinitis symptoms for at least 2 years at the time ofstudy in the season of the study.

  • Allergy skin tests positive for the airborne allergens present at the study timewithin 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 sleepscales 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

Exclusion Criteria:

  • Any chronic disease or other acute disease, which could influence central nervoussystem.

  • 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.

Study Design

Total Participants: 40
Study Start date:
March 01, 2010
Estimated Completion Date:
October 31, 2010

Study 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.