Clinical trial NCT01854619: Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
Official title: Photodisinfection for the Treatment of Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Sinusitis
Keywords: chronic rhinosinusitis
sinusitis
photodisinfection
photodynamic therapy
antimicrobial photodynamic therapy
aPDT
PDT
paranasal sinus diseases
respiratory tract infections
respiratory tract diseases
Lead sponsor: Ondine Biomedical Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-15
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: SNOT-22
timeFrame: 6 months
Secondary outcomes:
measure: Microbiome evaluation
timeFrame: 6 months
Other outcomes:
measure: Nasal and sinus symptom score
timeFrame: 6 months
measure: Endoscopic Evaluation Scoring
timeFrame: 6 months
measure: CT Scoring
timeFrame: 4 weeks
measure: Smell Testing (UPSIT)
timeFrame: 4 weeks
Locations:
city: Montreal
country: Canada
facility: Centre hospitalier de l'UdeM (CHUM)
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Martin Desrosiers, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.