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

Phase 2

Recruiting

• Conditions: Inflammatory and Immune System - Other inflammatory or immune system disorders; Chronic Sinusitis

• Registration Number: ACTRN12608000140358
• Lead Sponsor: aryx Pharma, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-18
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison from the change of baseline (entry) in the average Subject-Rated Total Sinus Symptom Score during the fourth (last) week of therapy for each method of administration[Measured at Days -13 to 0, days 1, 15, 29 and 36.]

Secondary Outcome Measures

Name	Time	Method
umber of percentage of participants experiencing improvement at Day 29 (Treatment period) based on the Physician-Rated Global Improvement Score[Day 29]