Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

NCT01854619 | Unknown

• 1 other identifier: OBI-1212-1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

• Microbiome evaluation

  6 months

Other Outcomes (4)

• Nasal and sinus symptom score

  6 months

• Endoscopic Evaluation Scoring

  6 months

• CT Scoring

  4 weeks

Study Arms (3)

Saline irrigation

ACTIVE COMPARATOR

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

Device: Saline irrigation

Double photodisinfection treatment

ACTIVE COMPARATOR

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)

Single photodisinfection treatment

ACTIVE COMPARATOR

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)

Interventions

Photodisinfection (antimicrobial photodynamic therapy, aPDT) DEVICE

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.

Also known as: PDT, photodynamic therapy, aPDT, light therapy, Sinuwave

Double photodisinfection treatment; Single photodisinfection treatment

Saline irrigation DEVICE

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

Also known as: Endoscopic saline irrigation

Saline irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• acute respiratory infection within last 2 weeks
• septal deviation restricting sinus access
• known allergy to methylene blue
• pregnant or breast feeding

Sponsors & Collaborators

• Ondine Biomedical Inc.: lead

Study Sites (1)

Centre hospitalier de l'UdeM (CHUM)

Montreal, Quebec, H2W 1T8, Canada

RECRUITING

Related Publications (5)

• 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.

  PMID: 22287461 BACKGROUND

• 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.

  PMID: 23070780 BACKGROUND

• 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.

  PMID: 23307793 BACKGROUND

• 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.

  PMID: 21290392 BACKGROUND

• 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.

  PMID: 19958597 BACKGROUND

MeSH Terms

Conditions

Sinusitis; Paranasal Sinus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases

Interventions

Photochemotherapy; Phototherapy

Condition Hierarchy (Ancestors)

Infections; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Martin Desrosiers, MD

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leandra Mfuna Endam, MS

CONTACT

514-890-8000; leandra_mfuna@yahoo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 15, 2013
• Study Start: May 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 17, 2013

Record last verified: 2013-05

Locations

CA (1)