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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Rhinitis; Chronic Sinus Congestion
• Intervention / Treatment: Drug: JT-1

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Schoch, PhD, Sponsor; Phone Number: +41792549286; Email: peter.schoch49@bluewin.ch

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8032
      • Clinic Hirslanden, ORL-Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jantar-1 (JT-1), 7% (w/w) aqueous solution; 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; JT-1 is a physiological salt with recently detected pharmacological properties that warrant testing for its therapeutic potential in chronic rhinitis and chronic sinusitis.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jantar GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2022
• Primary Completion (Actual): March 3, 2023
• Study Completion (Actual): March 3, 2023

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 14, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: rhinitis, sinusitis, rhinosinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Rhinitis
• Other Study ID Numbers: BASEC 2021-00564

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No