Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Chronic Sinusitis Clinical Trial

Official title:

Photodisinfection for the Treatment of Chronic Rhinosinusitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01854619
• Other study ID #: OBI-1212-1
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2013
• Last updated: May 15, 2013
• Start date: May 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2013
• Source: Ondine Biomedical Inc.
• Contact: Leandra Mfuna Endam, MS
• Phone: 514-890-8000
• Email: leandra_mfuna[@]yahoo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of light and a topically applied photosensitizer can relieve symptoms and clinically improve patients with chronic rhinosinusitis.

Description:

This clinical trial will be a prospective, randomized, single-center study utilizing two treatment assignments and a control group. The study is expected to enroll a total of 48 subjects. The intent of the study is to evaluate a single versus double treatment of photodisinfection in men and women suffering from chronic persistent rhinosinusitis with and without nasal polyposis. Each photodisinfection treatment group will be compared to a control group receiving saline irrigation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• history of chronic rhinosinusitis with and without nasal polyposis

• no antibiotics within 4 weeks

• no oral steroid use within 4 weeks

• no topical steroid use within 2 weeks

• endoscopic sinus surgery greater than 6 months previously

Exclusion Criteria:

• acute respiratory infection within last 2 weeks

• septal deviation restricting sinus access

• known allergy to methylene blue

• pregnant or breast feeding

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Sinusitis
• Sinusitis

Intervention

Device:
• Photodisinfection (antimicrobial photodynamic therapy, aPDT)
A 0.03% solution of methylene blue is irrigated into the involved paranasal sinus followed by placement of a saline filled balloon with a center light diffusing fiber optic. This is illuminated at 150 mW/cm2 power density for 8 minutes. This is repeated for each involved sinus.
• Saline irrigation
The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.

Locations

Country	Name	City	State
Canada	Centre hospitalier de l'UdeM (CHUM)	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Ondine Biomedical Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Biel MA, Jones JW, Pedigo L, Gibbs A, Loebel N. The effect of antimicrobial photodynamic therapy on human ciliated respiratory mucosa. Laryngoscope. 2012 Dec;122(12):2628-31. doi: 10.1002/lary.23502. Epub 2012 Oct 15. — View Citation

Biel MA, Pedigo L, Gibbs A, Loebel N. Photodynamic therapy of antibiotic-resistant biofilms in a maxillary sinus model. Int Forum Allergy Rhinol. 2013 Jun;3(6):468-73. doi: 10.1002/alr.21134. Epub 2013 Jan 10. — View Citation

Biel MA, Sievert C, Usacheva M, Teichert M, Balcom J. Antimicrobial photodynamic therapy treatment of chronic recurrent sinusitis biofilms. Int Forum Allergy Rhinol. 2011 Sep-Oct;1(5):329-34. doi: 10.1002/alr.20089. Epub 2011 Aug 18. — View Citation

Krespi YP, Kizhner V, Kara CO. Laser-induced microbial reduction in acute bacterial rhinosinusitis. Am J Rhinol Allergy. 2009 Nov-Dec;23(6):e29-32. doi: 10.2500/ajra.2009.23.3404. — View Citation

Krespi YP, Kizhner V. Phototherapy for chronic rhinosinusitis. Lasers Surg Med. 2011 Mar;43(3):187-91. doi: 10.1002/lsm.21042. Epub 2011 Feb 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nasal and sinus symptom score	This is a 5 item subjective list rated by patients from zero to severe.	6 months	No
Other	Endoscopic Evaluation Scoring	This is an endoscopic staging system for non-neoplastic sinonasal disease to evaluate therapeutic outcomes that is complex enough to incorporate the most important measures of the sinonasal cavity but simple enough to facilitate regular clinical use.	6 months	Yes
Other	CT Scoring	The American Academy of Otolaryngology & Task Force on Rhinosinusitis has recommended the Lund-Mackay system as the preferred method of staging of chronic rhinosinusitis (CRS). The Lund-Mackay staging system represents the most widely established method of sinus CT scoring in clinical trials. It scores each sinus area as a 0, 1, or 2 depending on the extent of mucosal opacification present and also includes a score for patency of the ostiomeatal unit.	4 weeks	Yes
Other	Smell Testing (UPSIT)	The University of Pennsylvania Smell Identification Test (UPSIT) is a scratch and sniff test used in North America since 1984 (Doty, 1984) and is the most widely used olfactory test in the world. The UPSIT is a multiple-forced-choice odour identification test. For each odorant there are four alternative responses and the subject is required to choose one of these even if no smell is perceived. It requires 10-15 min to be administered.	4 weeks	Yes
Primary	SNOT-22	The Sino-Nasal Outcome Test (SNOT-22) has been widely adopted in clinical practice and has been proved to be the most suitable and validated sinonasal outcome scoring system. The SNOT-22 is a disease-specific, quality-of-life-related measure of sinonasal function. Low score indicates good outcome.	6 months	Yes
Secondary	Microbiome evaluation	Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA.	6 months	No