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Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Primary Purpose

Chronic Sinusitis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Photodisinfection (antimicrobial photodynamic therapy, aPDT)
Saline irrigation
Sponsored by
Ondine Biomedical Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Sinusitis focused on measuring chronic rhinosinusitis, sinusitis, photodisinfection, photodynamic therapy, antimicrobial photodynamic therapy, aPDT, PDT, paranasal sinus diseases, respiratory tract infections, respiratory tract diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre hospitalier de l'UdeM (CHUM)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Saline irrigation

Double photodisinfection treatment

Single photodisinfection treatment

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Microbiome evaluation
Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA.

Full Information

First Posted
May 13, 2013
Last Updated
May 15, 2013
Sponsor
Ondine Biomedical Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01854619
Brief Title
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
Official Title
Photodisinfection for the Treatment of Chronic Rhinosinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ondine Biomedical Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Sinusitis
Keywords
chronic rhinosinusitis, sinusitis, photodisinfection, photodynamic therapy, antimicrobial photodynamic therapy, aPDT, PDT, paranasal sinus diseases, respiratory tract infections, respiratory tract diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saline irrigation
Arm Type
Active Comparator
Arm Description
Saline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control.
Arm Title
Double photodisinfection treatment
Arm Type
Active Comparator
Arm Description
Patients in the double treatment arm will receive a second photodisinfection treatment 4 weeks following the first treatment with regular follow-up visits
Arm Title
Single photodisinfection treatment
Arm Type
Active Comparator
Arm Description
The single-treatment group will receive a single photodisinfection treatment of all involved paranasal sinuses with multiple follow-up visits.
Intervention Type
Device
Intervention Name(s)
Photodisinfection (antimicrobial photodynamic therapy, aPDT)
Other Intervention Name(s)
PDT, photodynamic therapy, aPDT, light therapy, Sinuwave
Intervention Description
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
Intervention Name(s)
Saline irrigation
Other Intervention Name(s)
Endoscopic saline irrigation
Intervention Description
The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.
Primary Outcome Measure Information:
Title
SNOT-22
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microbiome evaluation
Description
Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Nasal and sinus symptom score
Description
This is a 5 item subjective list rated by patients from zero to severe.
Time Frame
6 months
Title
Endoscopic Evaluation Scoring
Description
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.
Time Frame
6 months
Title
CT Scoring
Description
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.
Time Frame
4 weeks
Title
Smell Testing (UPSIT)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leandra Mfuna Endam, MS
Phone
514-890-8000
Ext
14170
Email
leandra_mfuna@yahoo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Desrosiers, MD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier de l'UdeM (CHUM)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leandra Mfuna Endam, MS
Phone
514-890-8000
Ext
14170
Email
leandra_mfuna@yahoo.ca
First Name & Middle Initial & Last Name & Degree
Martin Desrosiers, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22287461
Citation
Biel MA, Sievert C, Usacheva M, Teichert M, Balcom J. Antimicrobial photodynamic therapy treatment of chronic recurrent sinusitis biofilms. Int Forum Allergy Rhinol. 2011 Sep-Oct;1(5):329-34. doi: 10.1002/alr.20089. Epub 2011 Aug 18.
Results Reference
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PubMed Identifier
23070780
Citation
Biel MA, Jones JW, Pedigo L, Gibbs A, Loebel N. The effect of antimicrobial photodynamic therapy on human ciliated respiratory mucosa. Laryngoscope. 2012 Dec;122(12):2628-31. doi: 10.1002/lary.23502. Epub 2012 Oct 15.
Results Reference
background
PubMed Identifier
23307793
Citation
Biel MA, Pedigo L, Gibbs A, Loebel N. Photodynamic therapy of antibiotic-resistant biofilms in a maxillary sinus model. Int Forum Allergy Rhinol. 2013 Jun;3(6):468-73. doi: 10.1002/alr.21134. Epub 2013 Jan 10.
Results Reference
background
PubMed Identifier
21290392
Citation
Krespi YP, Kizhner V. Phototherapy for chronic rhinosinusitis. Lasers Surg Med. 2011 Mar;43(3):187-91. doi: 10.1002/lsm.21042. Epub 2011 Feb 2.
Results Reference
background
PubMed Identifier
19958597
Citation
Krespi YP, Kizhner V, Kara CO. Laser-induced microbial reduction in acute bacterial rhinosinusitis. Am J Rhinol Allergy. 2009 Nov-Dec;23(6):e29-32. doi: 10.2500/ajra.2009.23.3404.
Results Reference
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Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

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