Chronic Rhinosinusitis (Diagnosis)NCT04171167
The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
A study testing Fluticasone Propionate in people with Chronic Rhinosinusitis (Diagnosis), run by Tampere University Hospital at 1 site in Finland.
Trial summary
Nitric oxide (NO) reflects changes in inflammatory state of the airways. In pulmonology fractional exhaled nitric oxide concentration (FeNO) has been linked to eosinophilic asthma and is used to guide overall disease control. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFinland
- Study dates
- 4 Apr 2017to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients willing to participate in the study
- Patients who are referred to ENT clinic due to chronic rhinosinusitis (EPOS criteria) or repeatedly diagnosed and treated acute rhinosinusitis
Who cannot join
- Endoscopic sinus surgery operation previously
- Septal deviation that would need an operation to correct the air flow
- Other severe disease that could pose a risk for the patient during the measurements based on the judgement of the treating physician
- Pregnancy or breastfeeding
- Allergy to used medications
- Inability to co-operate or to tolerate manipulation of the nose
Trial locations and contacts
1 site in 1 country.
About this study
Nitric oxide (NO) reflects changes in inflammatory state of the airways. In pulmonology fractional exhaled nitric oxide concentration (FeNO) has been linked to eosinophilic asthma and is used to guide overall disease control. The measurement of nasal nitric oxide (nNO) may reflect the disease burden and inflammatory phenotype of the paranasal sinuses.
The aim of our study is to evaluate the relation of chronic rhino sinusitis (CRS) severity and inflammatory status to nNO, maxillary sinus NO, nitrite, nitrate and cone beam computed tomography (CBCT).
Three groups (22 patients in each) of referred patients and and 22 healthy volunteers are recruited. Patients are grouped according to the CBCT score and viewed three times in 4-6 weeks intervals.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- Fluticasone Propionate
- Keywords
- Nasal nitric oxide, Nitric oxide metabolites
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
three visits: 0, after washout, after FP usage
| Study group | Role | What they receive |
|---|---|---|
| Frequently treated acute rhino sinusitis | Active comparator | Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study. Receives: Drug: Fluticasone Propionate |
| CRSsNP | Active comparator | Meets the European position paper criteria of CRS. Zinreich modification of Lund-Mackey scoringing: Opacification score < 21 and obstruction score 0-8. No visible nasal polyps in endoscopy Receives: Drug: Fluticasone Propionate |
| Severe CRSsNP and CRSwNP | Active comparator | Meets the European position paper criteria of CRS and not included in the first two groups. Receives: Drug: Fluticasone Propionate |
| Healthy volunteers | No intervention | No nasal symptoms or complaints. No interventions done. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal nitric oxide levels
Gaseous nitric oxide is measured nasal cavity and maxillary sinuses using EcoMedics CLD 88p analyser (ppb). Procedure according to ERS protocol.
Measured: Change between visit: 0, +5 weeks, +10weeks
Nitric oxide metabolite (nitrate, nitrite) levels
NO production is determined from saline lavage of nasal cavity and maxillary sinus by measuring the accumulation of nitrite, a stable metabolite of NO in aqueous milieu, by the Griess reaction
Measured: Change between visit: 0, +5 weeks, +10weeks
Secondary outcomes (1)
CBCT (Zinreich modified Lund-Mackay) scoring
A routine high resolution cone beam computed tomography (CBCT) is done to evaluate the initial status of the patients nose and repeated (with ultra-low-dose protocol) at every visit to demonstrate the the current state.
Opasification score scale 0-5, max. 50 and obstruction score 0-1 (0,5 steps), max. 8.
Measured: Change between visit: 0, +5 weeks, +10weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start4 Apr 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171167
- Sponsor's protocol ID
- R17011
- Status last verified
- Apr 2023
- First submitted
- 23 Oct 2018
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
- ClinicalTrials.gov ID
- NCT04171167
- Acronym / sponsor ID
- R17011
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Nasal nitric oxide, Nitric oxide metabolites
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 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.
Nitric oxide (NO) reflects changes in inflammatory state of the airways. In pulmonology fractional exhaled nitric oxide concentration (FeNO) has been linked to eosinophilic asthma and is used to guide overall disease control. The measurement of nasal nitric oxide (nNO) may reflect the disease burden and inflammatory phenotype of the paranasal sinuses.
The aim of our study is to evaluate the relation of chronic rhino sinusitis (CRS) severity and inflammatory status to nNO, maxillary sinus NO, nitrite, nitrate and cone beam computed tomography (CBCT).
Three groups (22 patients in each) of referred patients and and 22 healthy volunteers are recruited. Patients are grouped according to the CBCT score and viewed three times in 4-6 weeks intervals.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Frequently treated acute rhino sinusitis | Active comparator | Drug: Fluticasone PropionateDoes not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study. |
| CRSsNP | Active comparator | Drug: Fluticasone PropionateMeets the European position paper criteria of CRS. Zinreich modification of Lund-Mackey scoringing: Opacification score < 21 and obstruction score 0-8. No visible nasal polyps in endoscopy |
| Severe CRSsNP and CRSwNP | Active comparator | Drug: Fluticasone PropionateMeets the European position paper criteria of CRS and not included in the first two groups. |
| Healthy volunteers | No intervention | –No nasal symptoms or complaints. No interventions done. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients willing to participate in the study
- Patients who are referred to ENT clinic due to chronic rhinosinusitis (EPOS criteria) or repeatedly diagnosed and treated acute rhinosinusitis
Key exclusion criteria (6 listed)
- Endoscopic sinus surgery operation previously
- Septal deviation that would need an operation to correct the air flow
- Other severe disease that could pose a risk for the patient during the measurements based on the judgement of the treating physician
- Pregnancy or breastfeeding
- Allergy to used medications
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 |
|---|---|---|
| Fluticasone Propionatethree visits: 0, after washout, after FP usage | Drug | CRSsNP, Frequently treated acute rhino sinusitis, Severe CRSsNP and CRSwNP |
Primary outcome
Nasal nitric oxide levels
Time frame: Change between visit: 0, +5 weeks, +10weeks
Gaseous nitric oxide is measured nasal cavity and maxillary sinuses using EcoMedics CLD 88p analyser (ppb). Procedure according to ERS protocol.
Nitric oxide metabolite (nitrate, nitrite) levels
Time frame: Change between visit: 0, +5 weeks, +10weeks
NO production is determined from saline lavage of nasal cavity and maxillary sinus by measuring the accumulation of nitrite, a stable metabolite of NO in aqueous milieu, by the Griess reaction
1 secondary outcome
CBCT (Zinreich modified Lund-Mackay) scoring
Time frame: Change between visit: 0, +5 weeks, +10weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluticasone Propionate in people with Chronic Rhinosinusitis (Diagnosis), run by Tampere University Hospital at 1 site in Finland.
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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 May 2023. 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 Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Nasal nitric oxide levels (time frame: Change between visit: 0, +5 weeks, +10weeks). 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 9 May 2023.