A prospective, multi-center, randomized, controlled, single-blinded study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps. - AdvaCoat Mx sinus gel study for chronic rhinosinusitis without nasal polyps

Conditions: Subjects with chronic rhinosinusitis without nasal polyps, who have not had previous sinus surgery might be eligible for participation in this trial.
MedDRA version: 9.1Level: LLTClassification code 10052106Term: Rhinosinusitis

Registration Number: EUCTR2008-004226-16-NL

Lead Sponsor: Carbylan BioSurgery, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

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

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)).