Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Not Applicable

• Conditions: Chronic Sinusitis
• Interventions: Device: Saline irrigation; Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)

• Registration Number: NCT01854619
• Lead Sponsor: Ondine Biomedical Inc.

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2013-05
• Study Start: 2013-05
• Study First Submitted: 2013-05-13
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-15
• Last Update Submitted: 2013-05-15
• Last Update Posted: 2013-05-17
• Primary Completion: 2014-03
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline irrigation	Saline irrigation	Saline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control.
Double photodisinfection treatment	Photodisinfection (antimicrobial photodynamic therapy, aPDT)	Patients in the double treatment arm will receive a second photodisinfection treatment 4 weeks following the first treatment with regular follow-up visits
Single photodisinfection treatment	Photodisinfection (antimicrobial photodynamic therapy, aPDT)	The single-treatment group will receive a single photodisinfection treatment of all involved paranasal sinuses with multiple follow-up visits.

Primary Outcome Measures

Name	Time	Method
SNOT-22	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Microbiome evaluation	6 months	Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA.

Trial Locations

Locations (1)

Centre hospitalier de l'UdeM (CHUM); 🇨🇦 Montreal, Quebec, Canada