Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

May 15, 2013 updated by: Ondine Biomedical Inc.

Photodisinfection for the Treatment of Chronic Rhinosinusitis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1T8
        • Recruiting
        • Centre hospitalier de l'UdeM (CHUM)
        • Contact:
        • Principal Investigator:
          • Martin Desrosiers, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Saline irrigation
Saline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control.
Device: Saline irrigation
The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.
Other Names:
  • Endoscopic saline irrigation
Active Comparator: 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
Device: 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.
Other Names:
  • PDT
  • photodynamic therapy
  • light therapy
  • aPDT
  • Sinuwave
Active Comparator: Single photodisinfection treatment
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)
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.
Other Names:
  • PDT
  • photodynamic therapy
  • light therapy
  • aPDT
  • Sinuwave

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNOT-22
Time Frame: 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.
6 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal and sinus symptom score
Time Frame: 6 months
This is a 5 item subjective list rated by patients from zero to severe.
6 months
Endoscopic Evaluation Scoring
Time Frame: 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.
6 months
CT Scoring
Time Frame: 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.
4 weeks
Smell Testing (UPSIT)
Time Frame: 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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondine Biomedical Inc.

Investigators

  • Principal Investigator: Martin Desrosiers, MD, Université de Montréal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 15, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBI-1212-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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