Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Ondine Biomedical Inc.
Sponsor:
Information provided by (Responsible Party):
Ondine Biomedical Inc.
ClinicalTrials.gov Identifier:
NCT01854619
First received: May 13, 2013
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Chronic Sinusitis
Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)
Device: Saline irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Photodisinfection for the Treatment of Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by Ondine Biomedical Inc.:

Primary Outcome Measures:
  • SNOT-22 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA.


Other Outcome Measures:
  • Nasal and sinus symptom score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This is a 5 item subjective list rated by patients from zero to severe.

  • Endoscopic Evaluation Scoring [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 48
Study Start Date: May 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
  • aPDT
  • light therapy
  • 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
  • aPDT
  • light therapy
  • Sinuwave

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01854619

Contacts
Contact: Leandra Mfuna Endam, MS 514-890-8000 ext 14170 leandra_mfuna@yahoo.ca

Locations
Canada, Quebec
Centre hospitalier de l'UdeM (CHUM) Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: Leandra Mfuna Endam, MS    514-890-8000 ext 14170    leandra_mfuna@yahoo.ca   
Principal Investigator: Martin Desrosiers, MD         
Sponsors and Collaborators
Ondine Biomedical Inc.
Investigators
Principal Investigator: Martin Desrosiers, MD University of Montreal, CHUM
  More Information

Publications:
Responsible Party: Ondine Biomedical Inc.
ClinicalTrials.gov Identifier: NCT01854619     History of Changes
Other Study ID Numbers: OBI-1212-1
Study First Received: May 13, 2013
Last Updated: May 15, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ondine Biomedical Inc.:
chronic rhinosinusitis
sinusitis
photodisinfection
photodynamic therapy
antimicrobial photodynamic therapy
aPDT
PDT
paranasal sinus diseases
respiratory tract infections
respiratory tract diseases

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014