Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Ondine Biomedical

Status: Unknown

Conditions: Chronic Sinusitis

Treatments: Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT); Device: Saline irrigation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01854619

OBI-1212-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 3 patient groups

Saline irrigation

Active Comparator group

Description:

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

Treatment:

Device: Saline irrigation

Double photodisinfection treatment

Active Comparator group

Description:

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

Treatment:

Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)

Single photodisinfection treatment

Active Comparator group

Description:

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

Treatment:

Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)