None listed
Conditions
Brief summary
This is a multi-center, randomized, parallel-group, open-label, 2 treatment group study to evaluate the safety and efficacy of Fluticasone Proprionate Nasal Drops, Nasal Spray and Suspension for Nebulization via Nasal Inhalation for the treatment of chronic sinusitis in post-surgical subjects 18 years of age and older.
Interventions
a) Flixonase Nasule Drops one nasule per day for both nostrils 400 mcg per day for 4 wks b) Beconase Allergy & Hayfever 24 Hour nasal spray 2 spays per nostril twice per day 400 mcg/day for four weeks c) Flixotide Nebules 2 mg/mL nebule, via nasal inhalation once per day 400 mcg/day for four weeks
Sponsors
Naryx Pharma, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Changes from baseline in weekly average sum scores for the subject rated sinus symptoms of nasal congestion, post-nasal drip, and one of the following symptoms (identified as the worst at Screening): facial or sinus pain, facial or sinus pressure, or sinus headache; during the fourth week of therapy
Exclusion criteria
1. Females who are either pregnant, breastfeeding or of child bearing potential not using adequate birth control. 2. Evidence of infection by purulent drainage from an open sinus cavity visualized by nasal endoscopy 3. Nasal polyposis causing obstruction of any open sinus cavity rending them inaccessaible to endoscopic exam 4. Known allergy or hypersensitivity of fluticasone propionate or any of the formulation components of the product. 5. any disease or condition requiring corticosteroid therapy 6.Any use of antibiotics or anti-fungals, decongestants and/or antihistamines within the past 7 days prior to randomization 7. Any condition that would make the administration of fluticasone propionate clinically inadvisable 8. Use of any systemic corticosteroids within the past 30 days prior to screening 9. Use of nasal or inhaled corticosteroids within the past 14 days prior to randomization 10. Use of mast cell or leukotriene inhibitors when necessary within the past 14 days prior to randomization
Outcome results
None listed