Phase 4
Completed N=40
Fluticasone Furoate Treatment of Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis
Source: ClinicalTrials.gov NCT00997620 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance — 2.63; 3.95; 1.20; 1.83 number of errors
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance |
2.63; 3.95; 1.20; 1.83 | — |
| PRIMARY Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Errors of Commission. |
2.33; 1.54; 5.75; 1.58 | — |
| PRIMARY Performance on Test of Variables of Attention (TOVA) - a Standardized Test of Cognitive Performance, Response Time for Targets. |
387.58; 363.38; 412.47; 391.81 | — |
| SECONDARY Change in Epworth Sleep Scale |
13.28; 13.83; 12.80; 10.80 | < .05 sig |
| SECONDARY Change From Baseline in Nocturnal Rhinoconjunctivitis Quality of Life Questionaire |
-0.158; -0.67; -0.579; -0.904; -0.789; -0.90 | — |
| SECONDARY Nasal Symptom Scores |
12.65; 12.88; 13.74; 10.84; 13.53; 12.99 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00997620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.