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

Plain Language Summary

Simplified for easier understanding

This study is comparing three different ways of delivering a steroid nasal spray called fluticasone propionate to people who have had sinus surgery and still have ongoing chronic sinusitis (long-term inflammation of the sinuses). The three methods are: nose drops, a nasal spray, and a nebuliser (a device that turns liquid into a fine mist inhaled through the nose). All three deliver the same medication — researchers want to know which delivery method works best at reducing sinus symptoms like congestion, post-nasal drip, and facial pressure. You may be eligible if: - You are 18 years of age or older - You have had sinus surgery - You have ongoing symptoms of chronic sinusitis, including nasal congestion and post-nasal drip You may NOT be eligible if: - You are pregnant, breastfeeding, or of childbearing potential without adequate contraception - You have a known allergy to fluticasone propionate - You have an active sinus infection with purulent (infected) discharge - You have used antibiotics, nasal steroids, or oral steroids recently before the study - You have a condition that requires ongoing steroid therapy Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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