Trial Outcomes & Findings for Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis (NCT NCT00997620)

Last Updated: 2018-05-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

over 2 weeks

Results posted on

2018-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Overall Study STARTED	19	21
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Total n=40 Participants Total of all reporting groups
Age, Continuous	36 years n=5 Participants	38 years n=7 Participants	37 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: over 2 weeks

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance Baseline	2.63 number of errors Standard Deviation 2.98	3.95 number of errors Standard Deviation 3.18
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance After 2 weeks intervention	1.20 number of errors Standard Deviation 1.24	1.83 number of errors Standard Deviation 1.90

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. Baseline	2.33 non identified targets Standard Deviation 4.54	1.54 non identified targets Standard Deviation 3.72
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. After 2 weeks intervention	5.75 non identified targets Standard Deviation 14.10	1.58 non identified targets Standard Deviation 4.11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. Baseline	387.58 milliseconds Standard Deviation 77.03	363.38 milliseconds Standard Deviation 61.91
Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. After 2 weeks intervention	412.47 milliseconds Standard Deviation 66.16	391.81 milliseconds Standard Deviation 91.41

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Change in Epworth Sleep Scale Baseline	13.28 units on a scale Standard Deviation 3.42	13.83 units on a scale Standard Deviation 3.82
Change in Epworth Sleep Scale After 2 weeks intervention	12.80 units on a scale Standard Deviation 4.10	10.80 units on a scale Standard Deviation 5.48

SECONDARY outcome

Timeframe: 2 weeks

Population: The NRQLQ values represent the average for each intervention.

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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Difficulty getting to sleep	-0.158 units on a scale Standard Error .384	-0.67 units on a scale Standard Error 0.326
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Unable to get a good nights sleep	-0.579 units on a scale Standard Error 0.369	-0.904 units on a scale Standard Error 0.389
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Restless (tossing and turning)	-0.789 units on a scale Standard Error 0.329	-0.90 units on a scale Standard Error 0.37
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Having to get up because of stuffy nose.	-0.632 units on a scale Standard Error 0.298	1.49 units on a scale Standard Error 3.01
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Nasal congestion	-0.7894 units on a scale Standard Error 0.329	-0.76 units on a scale Standard Error 0.44
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Sinus pressure or pain	-0.738 units on a scale Standard Error 0.389	1.569 units on a scale Standard Error 4.2494
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Runny nose	-0.895 units on a scale Standard Error 0.252	-0.429 units on a scale Standard Error 0.405
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Post-nasal drip	-1.2105 units on a scale Standard Error 0.493	-1.333 units on a scale Standard Error 0.380
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Headache	-1.105 units on a scale Standard Error 0.431	-1.3 units on a scale Standard Error 0.576
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Feel tired and unrefreshed	-1.158 units on a scale Standard Error 0.448	-0.286 units on a scale Standard Error 0.962
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Nasal congestion or stuffy nose	-0.684 units on a scale Standard Error 0.380	-0.857 units on a scale Standard Error 0.340
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Congestion in sinuses	0.05 units on a scale Standard Error 0.354	-1.048 units on a scale Standard Error 0.297
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire time to clear nighttime drainage after waking	-0.474 units on a scale Standard Error 0.299	-1.190 units on a scale Standard Error 0.418
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Need to rub nose or eyes	-0.053 units on a scale Standard Error 0.0291	-1.4286 units on a scale Standard Error 0.369
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Have to take medication	-0.474 units on a scale Standard Error 0.337	-1.429 units on a scale Standard Error 0.434
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire Having to avoid symptom triggers	-0.474 units on a scale Standard Error 0.345	-1.190 units on a scale Standard Error 0.541

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants Placebo for comparison Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo	Fluticasone Furoate n=21 Participants Active treatment Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Nasal Symptom Scores Instaneous Baseline	12.65 units on a scale Standard Deviation 4.9	12.88 units on a scale Standard Deviation 4.26
Nasal Symptom Scores Instaneous Post 2 Weeks Therapy	13.74 units on a scale Standard Deviation 4.52	10.84 units on a scale Standard Deviation 6.34
Nasal Symptom Scores Reflective Baseline	13.53 units on a scale Standard Deviation 4.4	12.99 units on a scale Standard Deviation 3.73
Nasal Symptom Scores Reflective Post 2 Weeks Therapy	14.02 units on a scale Standard Deviation 4.65	11.19 units on a scale Standard Deviation 6.05

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fluticasone Furoate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lyndon E Mansfield, MD

Westernsky

Phone: 915-544-2557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place