Fluticasone Furoate Versus Placebo in Treating Daytime Somnolence and Cognitive Performance in Seasonal Allergic Rhinitis - Full Text View

Sponsor:	Western Sky Medical Research
Collaborator:	GlaxoSmithKline
Information provided by:	Western Sky Medical Research
ClinicalTrials.gov Identifier:	NCT00997620

Purpose

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 Drug: Placebo	Phase IV

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:

MedlinePlus related topics: Fever Hay Fever

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

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 ]

Estimated Enrollment:	50
Study Start Date:	March 2010
Estimated Study Completion Date:	October 2010
Estimated 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
Active Comparator: Fluticasone Furoate Active treatment	Drug: Fluticasone furoate Fluticasone nasal spray 2 sprays each nostril will be compared to similar appearing placebo Other Name: Veramyst

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Lyndon E. Mansfield MD, 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:	September 23, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Western Sky Medical Research:

Hay Fever
Daytime somnolence
Cognition

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Fluticasone

Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012