Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Photodisinfection for the Treatment of Chronic Rhinosinusitis

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)
* Device: Saline irrigation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saline irrigation<br>Saline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control. | Device: Saline irrigation<br>* The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.<br>* Other names: Endoscopic saline irrigation;|
| Active Comparator: Double photodisinfection treatment<br>Patients in the double treatment arm will receive a second photodisinfection treatment 4 weeks following the first treatment with regular follow-up visits | Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)<br>* 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.<br>* Other names: Sinuwave;|
| Active Comparator: Single photodisinfection treatment<br>The single-treatment group will receive a single photodisinfection treatment of all involved paranasal sinuses with multiple follow-up visits. | Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)<br>* 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.<br>* Other names: Sinuwave;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome evaluation | Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic rhinosinusitis, sinusitis, photodisinfection, photodynamic therapy, antimicrobial photodynamic therapy, aPDT, PDT, paranasal sinus diseases, respiratory tract infections, respiratory tract diseases