Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis

Study Overview
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Brief Summary
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Proof-of-concept study with a novel nasal spray in chronic rhinitis or chronic sinusitis. The study will involve 25 patients completing the study for a per protocol analysis.

Detailed Description
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Visit 1 (Day 0): Screening visit. Assessment of outcome measures Visit 2 (Day 7): Enrollment visit after a 1-week wash-out period. Enrolled to the Study are only patients who show a severe enough and stable disease (SNOT score >20 and change of SNOT score <15% compared to Visit 1, respectively). Visit 3 (Day 21): Assessment of outcome measures after 2-week treatment phase Visit 4 (Day 49): Follow-up visit

Official Title
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Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis

Conditions
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Chronic Rhinitis, Chronic Sinus Congestion

Intervention / Treatment
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* Drug: JT-1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinically diagnosed chronic allergic rhinitis or chronic sinusitis with no or a mild status of nasal polyp activity Disease lasting 12 weeks or longer Patients with moderate or severe symptoms (SNOT-22 score >20) Male or female at least 18 years old Females in childbearing age are requested to make a pregnancy test and to confirm in writing to take contraceptive measures until Follow-up Visit (Day 49). Patient understands German Exclusion Criteria: Severely purulent forms of sinusitis History of medication during the last four weeks not allowed: antibiotics, systemic or topical steroids allowed: nasal saline spray or irrigation, analgesics, decongestants, antihistamines Patient has a status of moderate or severe polyp activity in the nose Patient had sinus surgery in the past 6 months Patient needs O2 substitution Patient has cystic fibrosis Patient has primary ciliary dyskinesia Patient is demented or otherwise incapable of judgement

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm proof-of-concept study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Jantar-1 (JT-1), 7% (w/w) aqueous solution<br>Dosing regimen: ad libitum between at least 2 doses, in the morning and in the evening, and at most 10 doses per day. A dose corresponds to two strokes of 100ul each per nostril. | Drug: JT-1<br>* JT-1 is a physiological salt with recently detected pharmacological properties that warrant testing for its therapeutic potential in chronic rhinitis and chronic sinusitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Sino-Nasal Outcome Test (SNOT) score from baseline | Questionnaire of 22 questions on the subjective clinical symptoms of chronic rhinitis and chronic sinusitis, score between 0 (no symptoms) and 120 (worst possible disease) | Baseline (enrollment visit) and after 2-week treatment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Peak Nasal Inspiratory Flow (PNIF) from baseline | The PNIF meter measures the nasal airway patency in L/min. | Baseline (enrollment visit) and after 2-week treatment phase | 
| Change of Smell Diskettes Olfactory Test from baseline | Standardized 8-item odor (forced multiple choice) identification test (score of 0 to 8 correct answers) | Baseline (enrollment visit) and after 2-week treatment phase | 
| Change of Visual Analog Scale (VAS) of Headache Intensity | VAS is a method to measure the symptom severity. Patients mark a spot on a 100mm long line between no pain (left end) and worst possible pain (right end) which corresponds to their current pain level. The distance between the left end and the mark measures the subjective severity of pain. Minimum value: 0; maximum value: 100. A lower score after treatment compared to baseline means improved outcome. | Baseline (enrollment visit) and after 2-week treatment phase | 
| Change of Visual Analog Scale (VAS) of Nasal Discomfort | VAS is a method to measure the symptom severity. Patients mark a spot on a 100mm long line between no discomfort (left end) and worst possible discomfort (right end) which corresponds to their current level of discomfort. The distance between the left end and the mark measures the subjective severity of nasal discomfort. Minimum value: 0; maximum value: 100. A lower score after treatment compared to baseline means improved outcome. | Baseline (enrollment visit) and after 2-week treatment phase | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhinitis, sinusitis, rhinosinusitis