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
Sponsor study identifier
interventional
40
0 countries
N/A
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)Study Completion
October 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 15, 2009
Actual (reported)October 19, 2009
Actual (reported)March 2010
Date type not reportedThis date has not been verified as actual or estimated.
September 2010
Actual (reported)October 2010
Actual (reported)May 18, 2018
Actual (reported)Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance
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.
over 2 weeks
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission.
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.
after 2 weeks intervention
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets.
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.
over 2 weeks
Change in Epworth Sleep Scale
Baseline and after 2 weeks intervention
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire
2 weeks
Nasal Symptom Scores
2 weeks
Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis.
IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis
Fluticasone fuorate nasal spray 110 mcg 2 sprays each nostril am will be compared to similar appearing placebo given 2 sprays each nostril am. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of fluticasone furoate 110 mcg once daily and continue the evaluations.
40 participants (actual enrollment reported by the registry).
First Submitted
October 15, 2009
First Posted
October 19, 2009
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Vitamin D Plus Fluticasone Propionate
Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo. The subjects will receive one week placebo nasal spray to establish a baseline then they will then be switched to a nasal spray of Placebo once daily and continue the evaluations.
Contact the study team to confirm eligibility.
Primary Completion
September 2010
Actual (reported)Study Completion
October 2010
Actual (reported)Last Updated
May 18, 2018
Results First Posted
May 18, 2018
Record last verified: 2018-05
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Source: ClinicalTrials.gov.
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