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

This study has been completed.
Information provided by (Responsible Party):
Lyndon Mansfield, Western Sky Medical Research
ClinicalTrials.gov Identifier:
First received: October 15, 2009
Last updated: December 15, 2015
Last verified: June 2012
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.

Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Fluticasone furoate Nasal Spray
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Western Sky Medical Research:

Primary Outcome Measures:
  • Performance on Test of Variables of Attention (TOVA) - a standardized test of cognitive performance [ Time Frame: over 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Epworth sleep scale [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Nocturnal Rhinoconjunctivitis Quality of Life Questionaire [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Nasal Symptom Scores [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 41
Study Start Date: March 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo for comparison
Drug: Placebo
Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Other Name: Placebo Veramyst Nasal Spray
Active Comparator: Fluticasone Furoate
Active treatment
Drug: Fluticasone furoate Nasal Spray
Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo
Other Name: Veramyst Nasal Spray

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 two sprays in each nostril once daily will be compared to a placebo treated group of similar subjects with seasonal allergic rhinitis.

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts 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.
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Lyndon Mansfield, Director, Western Sky Medical Research
ClinicalTrials.gov Identifier: NCT00997620     History of Changes
Other Study ID Numbers: 2008-4 
Study First Received: October 15, 2009
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Western Sky Medical Research:
Hay Fever
Daytime somnolence

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 24, 2016