Seasonal Allergic Rhinitis
Conditions
Keywords
Hay Fever, Daytime somnolence, Cognition
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.
Interventions
DRUGFluticasone furoate Nasal Spray 110 mcg
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.
DRUGPlacebo
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.
Sponsors
GlaxoSmithKline
Western Sky Medical Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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, 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo for comparison
Placebo: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo | 19 |
| Fluticasone Furoate Active treatment
Fluticasone furoate Nasal Spray: Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Placebo | Fluticasone Furoate | Total |
|---|---|---|---|
| Age, Continuous | 36 years | 38 years | 37 years |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 21 |
| other Total, other adverse events | 0 / 19 | 0 / 21 |
| serious Total, serious adverse events | 0 / 19 | 0 / 21 |
Outcome results
Primary
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.
Time frame: over 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Placebo | 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 |
| Fluticasone Furoate | Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance | Baseline | 3.95 number of errors | Standard Deviation 3.18 |
| Fluticasone Furoate | Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance | After 2 weeks intervention | 1.83 number of errors | Standard Deviation 1.9 |
Primary
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.
Time frame: after 2 weeks intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Placebo | 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 14.1 |
| Fluticasone Furoate | Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. | Baseline | 1.54 non identified targets | Standard Deviation 3.72 |
| Fluticasone Furoate | Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. | After 2 weeks intervention | 1.58 non identified targets | Standard Deviation 4.11 |
Primary
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.
Time frame: over 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Placebo | 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 |
| Fluticasone Furoate | Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. | Baseline | 363.38 milliseconds | Standard Deviation 61.91 |
| Fluticasone Furoate | Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. | After 2 weeks intervention | 391.81 milliseconds | Standard Deviation 91.41 |
Secondary
Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire
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.
Time frame: 2 weeks
Population: The NRQLQ values represent the average for each intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Difficulty getting to sleep | -0.158 units on a scale | Standard Error 0.384 |
| Placebo | 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 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Restless (tossing and turning) | -0.789 units on a scale | Standard Error 0.329 |
| Placebo | 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 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Nasal congestion | -0.7894 units on a scale | Standard Error 0.329 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Sinus pressure or pain | -0.738 units on a scale | Standard Error 0.389 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Runny nose | -0.895 units on a scale | Standard Error 0.252 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Post-nasal drip | -1.2105 units on a scale | Standard Error 0.493 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Headache | -1.105 units on a scale | Standard Error 0.431 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Feel tired and unrefreshed | -1.158 units on a scale | Standard Error 0.448 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Nasal congestion or stuffy nose | -0.684 units on a scale | Standard Error 0.38 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Congestion in sinuses | 0.05 units on a scale | Standard Error 0.354 |
| Placebo | 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 |
| Placebo | 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 |
| Placebo | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Have to take medication | -0.474 units on a scale | Standard Error 0.337 |
| Placebo | 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 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Having to avoid symptom triggers | -1.190 units on a scale | Standard Error 0.541 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Difficulty getting to sleep | -0.67 units on a scale | Standard Error 0.326 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Headache | -1.3 units on a scale | Standard Error 0.576 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Unable to get a good nights sleep | -0.904 units on a scale | Standard Error 0.389 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | time to clear nighttime drainage after waking | -1.190 units on a scale | Standard Error 0.418 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Restless (tossing and turning) | -0.90 units on a scale | Standard Error 0.37 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Feel tired and unrefreshed | -0.286 units on a scale | Standard Error 0.962 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Having to get up because of stuffy nose. | 1.49 units on a scale | Standard Error 3.01 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Have to take medication | -1.429 units on a scale | Standard Error 0.434 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Nasal congestion | -0.76 units on a scale | Standard Error 0.44 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Nasal congestion or stuffy nose | -0.857 units on a scale | Standard Error 0.34 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Sinus pressure or pain | 1.569 units on a scale | Standard Error 4.2494 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Need to rub nose or eyes | -1.4286 units on a scale | Standard Error 0.369 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Runny nose | -0.429 units on a scale | Standard Error 0.405 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Congestion in sinuses | -1.048 units on a scale | Standard Error 0.297 |
| Fluticasone Furoate | Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire | Post-nasal drip | -1.333 units on a scale | Standard Error 0.38 |
Secondary
Change in Epworth Sleep Scale
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.
Time frame: Baseline and after 2 weeks intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change in Epworth Sleep Scale | Baseline | 13.28 units on a scale | Standard Deviation 3.42 |
| Placebo | Change in Epworth Sleep Scale | After 2 weeks intervention | 12.80 units on a scale | Standard Deviation 4.1 |
| Fluticasone Furoate | Change in Epworth Sleep Scale | Baseline | 13.83 units on a scale | Standard Deviation 3.82 |
| Fluticasone Furoate | Change in Epworth Sleep Scale | After 2 weeks intervention | 10.80 units on a scale | Standard Deviation 5.48 |
Comparison: The statistical analysis was of t testing of the difference of the mean between the baseline and after two weeks. The power analysis was prior to data collection was not performed for this test. The null hypothesis is no different, no difference between placebo and active treatment.p-value: <0.05t-test, 2 sided
Secondary
Nasal Symptom Scores
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.
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Nasal Symptom Scores | Reflective Post 2 Weeks Therapy | 14.02 units on a scale | Standard Deviation 4.65 |
| Placebo | Nasal Symptom Scores | Reflective Baseline | 13.53 units on a scale | Standard Deviation 4.4 |
| Placebo | Nasal Symptom Scores | Instaneous Baseline | 12.65 units on a scale | Standard Deviation 4.9 |
| Placebo | Nasal Symptom Scores | Instaneous Post 2 Weeks Therapy | 13.74 units on a scale | Standard Deviation 4.52 |
| Fluticasone Furoate | Nasal Symptom Scores | Reflective Baseline | 12.99 units on a scale | Standard Deviation 3.73 |
| Fluticasone Furoate | Nasal Symptom Scores | Instaneous Post 2 Weeks Therapy | 10.84 units on a scale | Standard Deviation 6.34 |
| Fluticasone Furoate | Nasal Symptom Scores | Reflective Post 2 Weeks Therapy | 11.19 units on a scale | Standard Deviation 6.05 |
| Fluticasone Furoate | Nasal Symptom Scores | Instaneous Baseline | 12.88 units on a scale | Standard Deviation 4.26 |