Recruiting

Photodynamic Therapy

Sponsor:

Ondine Biomedical Inc.

Code:

NCT01854619

Conditions

Chronic Sinusitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Photodisinfection (antimicrobial photodynamic therapy, aPDT)

Saline irrigation

Study Details

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.

Conditions

Chronic Sinusitis

Study ID

NCT01854619

Start date

May, 2013

Status verified date

May, 2013

Completion date

Mar, 2014

Anticipated

Primary completion date

Mar, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Saline irrigation

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

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

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.

Interventions

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.

Saline irrigation

The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.

Primary outcome measure

  • SNOT-22 [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Leandra Mfuna Endam, MS

514-890-8000leandra_mfuna@yahoo.ca

Locations

Centre hospitalier de l'UdeM (CHUM)

Recruiting

Montreal, Quebec, Canada, H2W 1T8

Contacts

Leandra Mfuna Endam, MS

514-890-8000leandra_mfuna@yahoo.ca

Principal Investigator:

Martin Desrosiers, MD

More Information

Sponsor

Ondine Biomedical Inc.

Last update posted

May 17, 2013

Last verified

May, 2013

Keywords

  • chronic rhinosinusitis
  • sinusitis
  • photodisinfection
  • photodynamic therapy
  • antimicrobial photodynamic therapy
  • aPDT
  • PDT
  • paranasal sinus diseases
  • respiratory tract infections
  • respiratory tract diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ondine Biomedical Inc. on 2013-05-17.