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

Jantar GmbH3 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Rhinitis Chronic Sinus Congestion

Interventions

JT-1DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinic Hirslanden, ORL-Center

Zurich, Canton of Zurich, Switzerland

Outcomes

Primary Outcomes

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)

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

Secondary Outcomes

Change of Peak Nasal Inspiratory Flow (PNIF) from baseline

The PNIF meter measures the nasal airway patency in L/min.

Time frame: 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)

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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