Fluticasone Furoate Versus Placebo in Treating Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Information source: Western Sky Medical Research
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: Fluticasone furoate (Drug); Placebo (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Western Sky Medical Research
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.
Clinical Details
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 design: Other, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Performance on Test of Variables of Attention (TOVA) - a standardized test of cognitive performance
Secondary outcome: Change in Epworth sleep scaleNocturnal Rhinoconjunctivitis Quality of Life Questionaire Nasal Symptom Scores
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: March 2010
Ending date: May 2010
Last updated: October 16, 2009
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