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The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171167
Recruitment Status : Recruiting
First Posted : November 20, 2019
Last Update Posted : May 14, 2020
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Fluticasone Propionate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Frequently treated acute rhino sinusitis
Does not meet the European position paper criteria of CRS: asymptomatic periods in between and no objective findings when entering the study.
Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage

Active Comparator: CRSsNP
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
Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage

Active Comparator: Severe CRSsNP and CRSwNP
Meets the European position paper criteria of CRS and not included in the first two groups.
Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage

No Intervention: Healthy volunteers
No nasal symptoms or complaints. No interventions done.



Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. CBCT (Zinreich modified Lund-Mackay) scoring [ Time Frame: Change between visit: 0, +5 weeks, +10weeks ]

    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.




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171167


Contacts
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Contact: Tamminen +358 03 311611 studyregp@gmail.com

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Tamminen         
Sponsors and Collaborators
Tampere University Hospital

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT04171167    
Other Study ID Numbers: R17011
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: May 14, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tampere University Hospital:
Nasal nitric oxide
Nitric oxide metabolites
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents