Subjects with chronic rhinosinusitis without nasal polyps, who have not had previous sinus surgery might be eligible for participation in this trial. MedDRA version: 9.1 Level: LLT Classification code 10052106 Term: Rhinosinusitis
Conditions
Interventions
Trade Name: Kenalog
Product Name: AdvaCoat Mx
Product Code: AdvaCoat Mx
Pharmaceutical Form: Injection*
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS Number: 76255
Concentration unit: mg/ml milligr
Sponsors
Carbylan BioSurgery, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of CRS defined as: - Symptoms present for >12 weeks - Two of the following: Anterior and/or posterior mucoid drainage Nasal congestion Facial pain / pressure / fullness - Both of the following: Nasal endoscopic examination confirming inflammation and/or edema of the ostiomeatal complex without the rpesence of polyps and/or previous sinus surgical procedures Evidence of CRS on CT (minimum score of 4 with at least two points coming from the sinuses). Images should be acquired or reformatted into coronal section, with a maximum thickness of 3 mm. Follow-up CT should be performed using a similar protocol to the original scan 2. Average Score of 40-80 mm on the Patient Subjective Symptom Score (PSSS) 3. 18 – 85 years of age 4. Adequate access for application of approximately 1.5mL of material on to Ostiomeatal Complex (OMC) 5. Willing and able to return for all required follow-up study visits. 6. Signed an informed consent form 7. Females of childbearing potential are not pregnant or lactating and agree not to become pregnant for the duration of the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unilateral sinus disease 2. Evidence of polyps within or beyond the middle meatus by nasal endoscopy 3. Samter’s Triad 4. Previous or planned nasal or sinus surgery, including sinuplasty 5. Steroid dependent asthma 6. A known sensitivity to hyaluronan products, corticosteroids or any excipients contained within the formulation of Kenacort A-10 7. Cystic fibrosis or any immune deficiency that may interfere with wound healing 8. Any disease or condition that interferes with safe completion of initial or follow-up assessments 9. Anatomical abnormalities within middle meatus by endoscopy 10. Current evidence of sinus muccocele 11. Nasal intubation within 4 weeks of study run-in period (Day -7) 12. Wegener’s granulomatosis or sarcoidosis 13. Suspicion of sinonasal neoplasm 14. Use of nasal irrigation during study duration 15. Use of systemic corticosteroids within 4 weeks of study run-in period (Day -7) 16. Pregnant or planning to get pregnant 17. Current use of orally inhaled corticosteroids 18. Active sinus infection as evidence by frank purulence/pus 19. Current use of systemic antibiotics 20. PRN use of nasal corticosteroids, oral and/or nasal decongestants/antihistamines, leukotriene inhibitors, and/or mastcell stabilizers (i.e.,all medications must be stable dosing for 14 days prior to study run-in period (Day -7)).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ;Primary end point(s): Safety; - number, timing, severity, duration and resolution of product and non-product related adverse events. Efficacy; - percent change-from-baseline in the individual and total of subjective symptom evaluations, each measured on a 100 mm visua analog scale. - change-from-baseline in CT-scan score. ;Main Objective: The purpose of this study is to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for the treatment of symptoms associated with chronic rhinosinusitis without nasal polyps that is refractory to conventional medical therapy. The AdvaCoat™ Mx is a bioresorbable hyaluronan-based gel that conforms and adheres to mucosal surfaces. The admixed TA is held within the gel and slowly released over approximately 30 days as the gel degrades. The current treatment of rhinosinusitis (nasal corticosteroid spray) cannot reach the ostiomeatal complex and will thus not result in optimal relieve. The sponsor and teh investigators hope to prove that the product is safe and effective in reducing the symptoms of chronic rhinosinusitis. | — |
Countries
Netherlands
Outcome results
None listed