Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT00997620
- Lead Sponsor
- Western Sky Medical Research
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis. Fluticasone Furoate Fluticasone furoate Nasal Spray 110 mcg IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis
- Primary Outcome Measures
Name Time Method Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance over 2 weeks The outcomes measures for TOVA are errors of omission. Targets which were not identified. Errors of commission are when targets are identified incorrectly. Reaction time is reported as the average time in milliseconds for the responses. The results are reported as mean and standard deviation as baseline and after 2 weeks of intervention. The difference between the means was evaluated by paired t testing.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. over 2 weeks The outcomes measures for TOVA are the length of time to respond to targets. The time function represents the average time spent in milliseconds spent on each target.
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. after 2 weeks intervention The outcomes measures for TOVA are errors of commission. Targets which were identified incorrectly. Targets which are not identified, errors of omission and average time of each target viewing.
- Secondary Outcome Measures
Name Time Method Change in Epworth Sleep Scale Baseline and after 2 weeks intervention The Epworth sleepiness scale measures is a validated test of daytime sleepiness which involved the subjects answering 8 questions. Each question is answered on a 0 - 3 scale with 3 being the most likely associated with drowsiness. The score is reported as a composite score of 8 questions, with a minimum score of 0 and a maximum score of 24. A higher composite score represents more likelihood of daytime sleepiness. It is administered between 1500 and 1700 daily.
Nasal Symptom Scores 2 weeks Total nasal symptom score was measured AM and PM. The reflective scale measures subjective symptoms over the previous 12 hours. Instantaneous symptoms measure how subjects felt at the present time. The score consists of subjective perception of nasal congestion, rhinorrhea, nasal itching and sneezing. The scale for each symptom is 0 - not present, 1- mild (present but minimal), 2 - moderate (symptoms are bothersome but tolerable), 3 - severe (symptoms are not tolerable). The baseline value was the mean of the 7 day placebo run-in for the combined scores. This was calculated for the placebo group and the fluticasone group for both the instantaneous and the reflective scores. The intervention time utilized the same combined AM and PM reflective and instantaneous scoring. The data was analyzed using two sample t test comparison of the placebo vs fluticasone furoate group. Low value, less symptoms. High value, more symptoms. Minimum score is 0. Maximum score is 24.
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire 2 weeks In nocturnal rhinoconjunctivitis quality of life questionnaire instrument to measure the effects of nasal disorder on nighttime sleep and awakening. It consists of 16 questions. The scale is from 0-6, 0 being not troubled and 6 reflecting extreme trouble. This survey is interpreted as a minimal clinically important difference of each question. A change of +/- 0.5 is a threshold of minimally important clinical difference. Higher value mean more disturbance.