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

NCT ID: NCT00997620

Last Updated: 2018-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-10-31

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.

Conditions

Seasonal Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo treatment given as a once daily dose intranasally.in subjects with active seasonal allergic rhinitis.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Fluticasone Furoate

IFluticasone Furoate 110 mcg given intranasly once daily in am as an active treatment of seasonal allergic rhinitis

Group Type: EXPERIMENTAL

Fluticasone furoate Nasal Spray 110 mcg

Intervention Type: DRUG

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.

Interventions

Fluticasone 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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Other Intervention Names

Fluticasone Furoate Nasal Spray; Placebo Veramyst Nasal Spray

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Western Sky Medical Research

OTHER

Sponsor Role: lead

Responsible Party

Lyndon Mansfield

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2008-4

Identifier Type: -

Identifier Source: org_study_id