Chronic SinusitisPhase 2NCT04163978
Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)
A Phase 2 study testing Nitric Oxide and Budesonide in people with Chronic Sinusitis, run by Sanotize Research and Development corp. at 1 site in Canada.
Trial summary
This a single center, randomized controlled trial to evaluate safety \& efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated recalcitrant chronic rhinosinusitis (RCRS). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- Nitric Oxide and Budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 27 Oct 2019to 3 May 2022
- Phase
- Phase 2
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained from the participant prior to entering the study.
- Must be ≥ 19 years of age unless local laws dictate otherwise
- English speaking
- Willing and able to return to the study site for protocol required visits.
- Documented diagnosis of chronic sinusitis with biofilm after a treatment of at least 3 months of a combination of well executed sinus surgery, regular irrigation with topical steroids or a mucosal atomization device and surfactants and at least one course of culture directed oral antibiotics
- Persistent or worsening symptoms within 30 days of wash-in with budesonide. Specifically, documented by two SNOT-22 scores greater than or equal to 20 indicating stable (within 9 points) or worsening symptoms. SNOT-22 evaluations must be at least 7 days and no more than 30 days apart. Second SNOT-22 must be used as baseline.
- Participant has been on a stable course of only Pulmicort and saline irrigation for a minimum of 30 days prior to randomization
- Must be willing to use an adequate and documented form of contraception (or abstinence) from the time of the first dose with the IMP until after the last dose of IMP
Who cannot join
- Presence of prior history of sinonasal tumors
- Isolated sphenoid sinusitis or other sinus cavities that are not accessible to a nasal/sinus rinse as done by the patient in the head forward position
- Autoimmune diseases affecting the upper airway eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc
- Immuno-compromised patients, and patients with impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)
- Severe underlying disease with anticipated survival less than 6 months
- Females who are pregnant, breastfeeding, or plan to become pregnant during the course of the study up to 1 weeks after the last dose/study visit
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- Has used any investigational drug(s) within 30 days preceding randomization visit (Day 1);
- Suffers from a condition, which, in the opinion of the medical investigator, would compromise their safety and / or their adherence to the study protocol
- Systemic antibiotics, corticosteroids or antifungals within 30 days of randomization
- Intranasal or irrigation with antibiotics, antifungals or antiseptics or any other sinusitis treatment other than Pulmicort within 30 days of randomization
- Has a family member living in the same household, also enrolled or planning to enroll in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Trial to Evaluate Safety & Efficacy of Topical Nitric Oxide Releasing Sinus Irrigation (NOSi) as Compared to Budesonide-Saline (Control) in the Management of Biofilm-Associated Recalcitrant Chronic Rhinosinusitis (RCRS)
This a single center, randomized controlled trial to evaluate safety \& efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated recalcitrant chronic rhinosinusitis (RCRS). It is hypothesized that a daily treatment of NOSi over a 6-week period will be safe and effective at reducing clinical symptoms associated with RCRS.
Read the detailed description
This is a prospective, single center, Phase 2, double-blinded, randomized, controlled, parallel group trial study. Up to fifty-four (54) participants will be enrolled (based on power analysis based on outcomes from a previous dose-tolerance study. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study and randomized in to the Investigational Medicinal Product (IMP) or Non Investigational Medicinal Product (NIMP) at a 2:1 ratio (NOSi:Budesonide). Each participant will be managed as an outpatient for the 42 days of the study. Participants will be administered NOSi or budesonide in saline by self-administration, at home, as a sinus irrigation to their nasopharynx and sinuses once a day. Participants will be asked to return to the clinic for evaluations on Day 21(±2), Day 43(±2) and Day 63 (±2) following the start of study interventions.
- Conditions
- Chronic Sinusitis
- Being tested
- Nitric Oxide, Budesonide
- Keywords
- nitric oxide, sinusitis
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric OxideDrug
Also called Treatment
in situ 240mL nitric oxide releasing sinus irrigation solution
BudesonideDrug
Also called Comparator
Saline based sinus irrigation 1mg Budesinide solution
| Study group | Role | What they receive |
|---|---|---|
| Nitric oxide releasing solution (NOSi) | Experimental | DailyTopical sinus irrigation delivery of 240mL NOSi Receives: Drug: Nitric Oxide |
| Budesonide -saline | Active comparator | Daily Topical sinus irrigation delivery of 240 mL of 1 mg Budesonide-saline Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis (RCRS) as measured by the Sino-Nasal Outcome Test (SNOT-22)
Proportion of participants experiencing a 9-point reduction in Sino-Nasal Outcome test (SNOT-22) score (0-5 scale of 22 parameters with a total maxmimum score of 110 and an increased value representing worsening of condition)
Measured: 42 days
To assess the safety of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis
Severity and frequency of adverse events as well as clinically significant Changes in laboratory findings, vital signs, histology, olfaction, and methemoglobin levels.
Measured: 63 days
Secondary outcomes (5)
To evaluate the efficacy of NOSi compared to Budesonide on the reduction of Modified Lund-Kennedy Scores (MLK)
Mean change in MLK score as compared to control (Scale of 0-2 for 6 locations on each side (maximum total score 24); increase represents worsening
Measured: Days 21, 42, 63
To evaluate the efficacy of NOSi compared to Budesonide on quality of life improvements (EQ-5D-5L);
Mean change in EQ-5D-5L index score as compared to control (Scale 0-100; increase indicates worsening)
Measured: Days 21, 42, 63
To evaluate the efficacy of NOSi compared to Budesonide on the density of pathogens
Mean change in pathogen density compared to control; (log10 cfu/g)
Measured: Days 21, 42, 63
To evaluate the efficacy of NOSi compared to Budesonide on cilia functionality
Proportion of participants with functional cilia which is known to be denuded by biofilm as determined by the saccharin test compared to control
Measured: Days 43 & 63
To evaluate the efficacy of NOSi compared to Budesonide on biofilm elimination
Proportion of participants with biofilm elimination compared to control
Measured: Days 43 & 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start27 Oct 2019
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective double-blind, randomized, controlled, parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanotize Research and Development corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amin Javer, MD, Principal investigator, St. Paul's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163978
- Sponsor's protocol ID
- NOSi-CTP-02
- Status last verified
- Apr 2022
- First submitted
- 31 Oct 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial to Evaluate Safety & Efficacy of Topical Nitric Oxide Releasing Sinus Irrigation (NOSi) as Compared to Budesonide-Saline (Control) in the Management of Biofilm-Associated Recalcitrant Chronic Rhinosinusitis (RCRS)
- ClinicalTrials.gov ID
- NCT04163978
- Acronym / sponsor ID
- NOSi-CTP-02
- Conditions
- Chronic Sinusitis
- Keywords
- nitric oxide, sinusitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Sanotize Research and Development corp.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2019 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 15 Nov 2019 (actual)
- 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.
This a single center, randomized controlled trial to evaluate safety \& efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated recalcitrant chronic rhinosinusitis (RCRS). It is hypothesized that a daily treatment of NOSi over a 6-week period will be safe and effective at reducing clinical symptoms associated with RCRS.
Detailed description
This is a prospective, single center, Phase 2, double-blinded, randomized, controlled, parallel group trial study. Up to fifty-four (54) participants will be enrolled (based on power analysis based on outcomes from a previous dose-tolerance study. Screening data will be reviewed to determine participant eligibility. Participants who meet all inclusion criteria and none of the exclusion criteria will be entered into the study and randomized in to the Investigational Medicinal Product (IMP) or Non Investigational Medicinal Product (NIMP) at a 2:1 ratio (NOSi:Budesonide). Each participant will be managed as an outpatient for the 42 days of the study. Participants will be administered NOSi or budesonide in saline by self-administration, at home, as a sinus irrigation to their nasopharynx and sinuses once a day. Participants will be asked to return to the clinic for evaluations on Day 21(±2), Day 43(±2) and Day 63 (±2) following the start of study interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective double-blind, randomized, controlled, parallel group
| Arm | Type | Receives |
|---|---|---|
| Nitric oxide releasing solution (NOSi) | Experimental | Drug: Nitric OxideDailyTopical sinus irrigation delivery of 240mL NOSi |
| Budesonide -saline | Active comparator | Drug: BudesonideDaily Topical sinus irrigation delivery of 240 mL of 1 mg Budesonide-saline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent must be obtained from the participant prior to entering the study.
- Must be ≥ 19 years of age unless local laws dictate otherwise
- English speaking
- Willing and able to return to the study site for protocol required visits.
- Documented diagnosis of chronic sinusitis with biofilm after a treatment of at least 3 months of a combination of well executed sinus surgery, regular irrigation with topical steroids or a mucosal atomization device and surfactants and at least one course of culture directed oral antibiotics
Key exclusion criteria (11 listed)
- Presence of prior history of sinonasal tumors
- Isolated sphenoid sinusitis or other sinus cavities that are not accessible to a nasal/sinus rinse as done by the patient in the head forward position
- Autoimmune diseases affecting the upper airway eg Systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis etc
- Immuno-compromised patients, and patients with impairment in mucociliary function (e.g., cystic fibrosis, Kartagener syndrome)
- Severe underlying disease with anticipated survival less than 6 months
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 |
|---|---|---|
| Nitric OxideAlso: Treatmentin situ 240mL nitric oxide releasing sinus irrigation solution | Drug | Nitric oxide releasing solution (NOSi) |
| BudesonideAlso: ComparatorSaline based sinus irrigation 1mg Budesinide solution | Drug | Budesonide -saline |
Primary outcome
To assess the efficacy of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis (RCRS) as measured by the Sino-Nasal Outcome Test (SNOT-22)
Time frame: 42 days
Proportion of participants experiencing a 9-point reduction in Sino-Nasal Outcome test (SNOT-22) score (0-5 scale of 22 parameters with a total maxmimum score of 110 and an increased value representing worsening of condition)
To assess the safety of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis
Time frame: 63 days
Severity and frequency of adverse events as well as clinically significant Changes in laboratory findings, vital signs, histology, olfaction, and methemoglobin levels.
5 secondary outcomes
To evaluate the efficacy of NOSi compared to Budesonide on the reduction of Modified Lund-Kennedy Scores (MLK)
Time frame: Days 21, 42, 63
To evaluate the efficacy of NOSi compared to Budesonide on quality of life improvements (EQ-5D-5L);
Time frame: Days 21, 42, 63
To evaluate the efficacy of NOSi compared to Budesonide on the density of pathogens
Time frame: Days 21, 42, 63
To evaluate the efficacy of NOSi compared to Budesonide on cilia functionality
Time frame: Days 43 & 63
To evaluate the efficacy of NOSi compared to Budesonide on biofilm elimination
Time frame: Days 43 & 63
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Amin Javer, MD principal investigator
St. Paul's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitric Oxide and Budesonide in people with Chronic Sinusitis, run by Sanotize Research and Development corp. 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 30 Jun 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of NOSi compared to Budesonide on disease specific quality of life in participants with biofilm-associated recalcitrant chronic rhinosinusitis (RCRS) as measured by the Sino-Nasal Outcome Test (SNOT-22) (time frame: 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2022.