Chronic Sinusitis
Conditions
Keywords
chronic rhinosinusitis, sinusitis, photodisinfection, photodynamic therapy, antimicrobial photodynamic therapy, aPDT, PDT, paranasal sinus diseases, respiratory tract infections, respiratory tract diseases
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.
Interventions
DEVICEPhotodisinfection (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.
DEVICESaline irrigation
The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.
Sponsors
Ondine Biomedical Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Microbiome evaluation | 6 months | Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nasal and sinus symptom score | 6 months | This is a 5 item subjective list rated by patients from zero to severe. |
| Endoscopic Evaluation Scoring | 6 months | 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. |
| CT Scoring | 4 weeks | 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. |
| Smell Testing (UPSIT) | 4 weeks | 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. |
Countries
Canada
Contacts
Primary ContactLeandra Mfuna Endam, MS
Outcome results
None listed