A prospective study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps.

Phase 2

Completed

• Conditions: Chronic rhinosinusitis; chronic sinusitis; 10024970

• Registration Number: NL-OMON32392
• Lead Sponsor: Carbylan BioSurgery, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 49

Inclusion Criteria

1. Diagnosis of CRS defined as:
- Symptoms present for >12 consecutive weeks
- At least 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 presence 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; reference Table 1 for grading scale);2. Average score of 40-80 mm on the Patient Subjective Symptom Score (PSSS) at the end of the run-in period
3. 18 - 85 years of age
4. Adequate access for application of 3.0 mL of material (1.5 mL per side) onto Ostiomeatal Complex (OMC)
5. Willing and able to return for all required follow-up study visits and complete study diary and questionnaires.
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

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 mucocele
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 evidenced by frank purulence/pus
19. Current or planned use of systemic antibiotics
20. PRN use of nasal corticosteroids, oral and/or nasal decongestants/antihistamines, leukotriene inhibitors, and/or mast-cell stabilizers (i.e., all medications must be stable dosing for 14 days prior to study run-in period (Day -7)).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety;<br /><br>- number, severity and product related 'adverse events'. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Efficacy;<br /><br>- Percent change from baseline in total of subjective symptom evaluations<br /><br>(using questionnaires)<br /><br>- Change from baseline in CT-scan score</p><br>