CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Fluticasone furoate Nasal Spray 110 mcg +1 moredrug
Likely dose
Fluticasone furoate Nasal Spray 110 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00997620
NCT00997620Phase 4Completed

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

Western Sky Medical Research·interventional·Posted Oct 19, 2009·Updated May 18, 2018

In Brief

A Phase 4 clinical trial evaluating Fluticasone furoate Nasal Spray 110 mcg and Placebo for Seasonal Allergic Rhinitis. Completed, enrolled 40 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsGlaxoSmithKline

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2009
Enrollment StartMar 1, 2010
Primary CompletionSep 1, 2010
Study CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.7 years ago

Interventions

Fluticasone furoate Nasal Spray 110 mcgdrug

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.

Placebodrug

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.