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

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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

Tracking Information
First Submitted Date  ICMJE October 23, 2018
First Posted Date  ICMJE November 20, 2019
Last Update Posted Date May 14, 2020
Actual Study Start Date  ICMJE April 4, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
Official Title  ICMJE The Causal Relation of Nasal Nitric Oxide Levels to the Severity of Chronic Rhinosinusitis and Its Inflammatory Phenotype
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Chronic Rhinosinusitis (Diagnosis)
Intervention  ICMJE Drug: Fluticasone Propionate
three visits: 0, after washout, after FP usage
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fluticasone Propionate
  • 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
    Intervention: Drug: Fluticasone Propionate
  • Active Comparator: Severe CRSsNP and CRSwNP
    Meets the European position paper criteria of CRS and not included in the first two groups.
    Intervention: Drug: Fluticasone Propionate
  • No Intervention: Healthy volunteers
    No nasal symptoms or complaints. No interventions done.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2019)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tamminen +358 03 311611 studyregp@gmail.com
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04171167
Other Study ID Numbers  ICMJE R17011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tampere University Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP