Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-03-31

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.

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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.

Conditions

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Chronic Sinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saline irrigation

Saline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control.

Group Type ACTIVE_COMPARATOR

Saline irrigation

Intervention Type DEVICE

The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.

Double photodisinfection treatment

Patients in the double treatment arm will receive a second photodisinfection treatment 4 weeks following the first treatment with regular follow-up visits

Group Type ACTIVE_COMPARATOR

Photodisinfection (antimicrobial photodynamic therapy, aPDT)

Intervention Type DEVICE

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.

Single photodisinfection treatment

The single-treatment group will receive a single photodisinfection treatment of all involved paranasal sinuses with multiple follow-up visits.

Group Type ACTIVE_COMPARATOR

Photodisinfection (antimicrobial photodynamic therapy, aPDT)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Saline irrigation

The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.

Intervention Type DEVICE

Other Intervention Names

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PDT photodynamic therapy aPDT light therapy Sinuwave Endoscopic saline irrigation

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No