RecruitingPhase 2ACTRN12608000140358

An Open-Label, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of Flutcasone Propionate Nasal Drops, Nasal Spray and Suspension for Nebulization via Nasal Inhalation in Post-Surgical Subjects with Chronic Sinusitis

A randomised controlled trial evaluating the safety and efficacy of Flutcasone Propionate Nasal Drops, Nasal Spray and Suspension for Nebulization in post-surgical participants with chronic sinusitis


Sponsor

Naryx Pharma, Inc.

Enrollment

30 participants

Start Date

Jul 12, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

  • 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 Criteria2

  • Females who are either pregnant, breastfeeding or of child bearing potential not using adequate birth control.
  • 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

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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

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


Locations(1)

Australia

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ACTRN12608000140358


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