Chronic SinusitisNCT01854619
Photodynamic Therapy for the Treatment of Chronic Rhinosinusitis
A study testing Photodisinfection (antimicrobial photodynamic therapy, aPDT) and Saline irrigation in people with Chronic Sinusitis, run by Ondine Biomedical Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Photodisinfection (antimicrobial photodynamic therapy, aPDT) and Saline irrigation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- May 2013to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- acute respiratory infection within last 2 weeks
- septal deviation restricting sinus access
- known allergy to methylene blue
- pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier de l'UdeM (CHUM)
Montreal, Quebec, H2W 1T8
Leandra Mfuna Endam, MS, 514-890-8000 ext. 14170, leandra_mfuna@yahoo.ca
Martin Desrosiers, MD
About this study
Official title: Photodisinfection for the Treatment of Chronic Rhinosinusitis
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.
Read the 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.
- Conditions
- Chronic Sinusitis
- Being tested
- Photodisinfection (antimicrobial photodynamic therapy, aPDT), Saline irrigation
- Keywords
- chronic rhinosinusitis, sinusitis, photodisinfection, photodynamic therapy, antimicrobial photodynamic therapy, aPDT, PDT, paranasal sinus diseases, respiratory tract infections, respiratory tract diseases
- Medical subject headings
- Sinusitis, Paranasal Sinus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodisinfection (antimicrobial photodynamic therapy, aPDT)Device
Also called PDT, photodynamic therapy, aPDT, light therapy
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 irrigationDevice
Also called Endoscopic saline irrigation
The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.
| Study group | Role | What they receive |
|---|---|---|
| Saline irrigation | Active comparator | Saline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control. Receives: 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 Receives: 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. Receives: Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Microbiome evaluation
Microbiological conventional cultures, gene expression profiling and microbiome profiling by 16s RNA.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startMay 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondine Biomedical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Desrosiers, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854619
- Sponsor's protocol ID
- OBI-1212-1
- Status last verified
- May 2013
- First submitted
- 13 May 2013
- Last updated
- 17 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22287461Biel 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.
PubMed 23070780Biel 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.
PubMed 23307793Krespi 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.
PubMed 21290392Krespi 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.
PubMed 19958597
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photodisinfection for the Treatment of Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT01854619
- Acronym / sponsor ID
- OBI-1212-1
- Conditions
- Chronic Sinusitis
- Keywords
- chronic rhinosinusitis, sinusitis, photodisinfection, photodynamic therapy, antimicrobial photodynamic therapy, aPDT, PDT, paranasal sinus diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Ondine Biomedical Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline irrigation | Active comparator | Device: Saline irrigationSaline irrigation via syringe will be administered using a sinus irrigation catheter under endoscopic control. |
| Double photodisinfection treatment | Active comparator | Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)Patients in the double treatment arm will receive a second photodisinfection treatment 4 weeks following the first treatment with regular follow-up visits |
| Single photodisinfection treatment | Active comparator | Device: Photodisinfection (antimicrobial photodynamic therapy, aPDT)The single-treatment group will receive a single photodisinfection treatment of all involved paranasal sinuses with multiple follow-up visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- acute respiratory infection within last 2 weeks
- septal deviation restricting sinus access
- known allergy to methylene blue
- pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photodisinfection (antimicrobial photodynamic therapy, aPDT)Also: PDT, photodynamic therapy, aPDT, light therapyA 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. | Device | Double photodisinfection treatment, Single photodisinfection treatment |
| Saline irrigationAlso: Endoscopic saline irrigationThe active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control. | Device | Saline irrigation |
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.
1 secondary outcome
Microbiome evaluation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
- Background: PubMed 22287461Biel 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.
- Background: PubMed 23070780Biel 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.
- Background: PubMed 23307793Biel 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.
- Background: PubMed 21290392Krespi 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.
- Background: PubMed 19958597Krespi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Desrosiers, MD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photodisinfection (antimicrobial photodynamic therapy, aPDT) and Saline irrigation in people with Chronic Sinusitis, run by Ondine Biomedical Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leandra Mfuna Endam, MS (514-890-8000 ext. 14170, leandra_mfuna@yahoo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNOT-22 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01854619, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2013.