Clinical Trial: Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Photodisinfection for the Treatment of Chronic Rhinosinusitis

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 Summary: 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.
Sponsor: Ondine Biomedical Inc.

Current Primary Outcome: SNOT-22 [ Time Frame: 6 months ]

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.


Original Primary Outcome: SNOT-22 [ Time Frame: 6 months ]

The Sino-Nasal Outcome Test (SNOT-22) has been widely adopted in clinical practice and has been proved to be the most suitable sinonasal outcome scoring system. The SNOT-22 is a disease-specific, quality-of-life-related measure of sinonasal function. Low score indicates good outcome.


Current Secondary Outcome: Microbiome evaluation [ Time Frame: 6 months ]

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


Original Secondary Outcome: Same as current

Information By: Ondine Biomedical Inc.

Dates:
Date Received: May 13, 2013
Date Started: May 2013
Date Completion: March 2014
Last Updated: May 15, 2013
Last Verified: May 2013