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

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ClinicalTrials.gov Identifier: NCT00997620
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Fluticasone furoate Nasal Spray Drug: Placebo Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2010
Primary Completion Date : September 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Performance on Test of Variables of Attention (TOVA) - a standardized test of cognitive performance [ Time Frame: over 2 weeks ]

Secondary Outcome Measures :
  1. Change in Epworth sleep scale [ Time Frame: 2 weeks ]
  2. Nocturnal Rhinoconjunctivitis Quality of Life Questionaire [ Time Frame: 2 weeks ]
  3. Nasal Symptom Scores [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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.
More Information

Responsible Party: Lyndon Mansfield, Director, Western Sky Medical Research
ClinicalTrials.gov Identifier: NCT00997620     History of Changes
Other Study ID Numbers: 2008-4
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: June 2012

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

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