A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray (FFNS) 110 mcg, administered either once daily or twice daily, compared with placebo, as effective monotherapy in the treatment of uncomplicated acute rhinosinusitis (ARS) in adult and adolescent subjects 12 years of age and older.
- Conditions
- uncomplicated acute rhinosinusitis (ARS)10024970
- Registration Number
- NL-OMON35004
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
• Age >= 12 years.
• Subject has provided an informed consent to participate. An appropriately signed and dated consent must be obtained from the parents or guardian of a subject who is under the legal age of consent.
• Diagnosis of uncomplicated acute rhinosinusitis
Subject has two or more major symptoms of uncomplicated acute rhinosinusitis [nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip];
• One symptom must be sinus headache/pressure or facial pain/pressure; and
• Subject has experienced symptoms for at least 5 days and no more than 8 days prior to the screening visit (Visit 1).
• Based on the investigator*s clinical judgement, subject has fulminant bacterial rhinosinusitis during the screening period including Visits 1 and 2.
• Acute rhinosinusitis in the past 12 weeks.
• Other sinonasal conditions in past 3 years.
• Allergic rhinitis.
• Influenza, candida-infection or ulcerations of the nose, otitis media.
• Obstructions like septumdeviation of polips.
• Antibiotica airway infections in the past 30 days.
• Use of analgecs (past 24 hours), corticosteroids (intranasal 4 weeks, others 8 weeks), other drugs infuencing nasal symptoms (detailed specification: see protocol).
• Swokers.
• Pregnancy and lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy endpoint for the study is the mean change from baseline in<br /><br>daily major symptom score (MSS) over the entire treatment period. The MSS is<br /><br>the sum of three individual symptom scores for (1) nasal congestion/stuffiness,<br /><br>(2) sinus headache/pressure or facial pain/pressure, and (3) postnasal drip<br /><br>that are rated by the subject using a 0 to 3 scale.</p><br>
- Secondary Outcome Measures
Name Time Method