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

NCT05331222 | Terminated DMC

• 1 other identifier: BASEC 2021-00564
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhinitis; Chronic Sinus Congestion

Keywords

rhinitis, sinusitis, rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change of Peak Nasal Inspiratory Flow (PNIF) from baseline

  Baseline (enrollment visit) and after 2-week treatment phase

• Change of Smell Diskettes Olfactory Test from baseline

  Baseline (enrollment visit) and after 2-week treatment phase

• Change of Visual Analog Scale (VAS) of Headache Intensity

  Baseline (enrollment visit) and after 2-week treatment phase

• Change of Visual Analog Scale (VAS) of Nasal Discomfort

  Baseline (enrollment visit) and after 2-week treatment phase

Study Arms (1)

Jantar-1 (JT-1), 7% (w/w) aqueous solution

EXPERIMENTAL

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

Interventions

JT-1 DRUG

JT-1 is a physiological salt with recently detected pharmacological properties that warrant testing for its therapeutic potential in chronic rhinitis and chronic sinusitis.

Jantar-1 (JT-1), 7% (w/w) aqueous solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jantar GmbH: lead

Study Sites (1)

Clinic Hirslanden, ORL-Center

Zurich, Canton of Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Rhinitis; Sinusitis; Rhinosinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases

Study Officials

• Hans Rudolf Briner, KD MD

  ORL-Center, Clinic Hirslanden, Zurich, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm proof-of-concept study

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 15, 2022
• Study Start: September 30, 2022
• Primary Completion: March 3, 2023
• Study Completion: March 3, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03

Locations

CH (1)