Back to resultsProof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Primary Purpose
Chronic Rhinitis, Chronic Sinus Congestion
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
JT-1
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Rhinitis focused on measuring rhinitis, sinusitis, rhinosinusitis
Eligibility Criteria
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
Sites / Locations
- Clinic Hirslanden, ORL-Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jantar-1 (JT-1), 7% (w/w) aqueous solution
Arm Description
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change of Peak Nasal Inspiratory Flow (PNIF) from baseline
The PNIF meter measures the nasal airway patency in L/min.
Change of Smell Diskettes Olfactory Test from baseline
Standardized 8-item odor (forced multiple choice) identification test (score of 0 to 8 correct answers)
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05331222
Brief Title
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Official Title
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
regulatory issues
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
March 3, 2023 (Actual)
Study Completion Date
March 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jantar GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinitis, Chronic Sinus Congestion
Keywords
rhinitis, sinusitis, rhinosinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-arm proof-of-concept study
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jantar-1 (JT-1), 7% (w/w) aqueous solution
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JT-1
Intervention Description
JT-1 is a physiological salt with recently detected pharmacological properties that warrant testing for its therapeutic potential in chronic rhinitis and chronic sinusitis.
Primary Outcome Measure Information:
Title
Change of Sino-Nasal Outcome Test (SNOT) score from baseline
Description
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 Outcome Measure Information:
Title
Change of Peak Nasal Inspiratory Flow (PNIF) from baseline
Description
The PNIF meter measures the nasal airway patency in L/min.
Time Frame
Baseline (enrollment visit) and after 2-week treatment phase
Title
Change of Smell Diskettes Olfactory Test from baseline
Description
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
Title
Change of Visual Analog Scale (VAS) of Headache Intensity
Description
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
Title
Change of Visual Analog Scale (VAS) of Nasal Discomfort
Description
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.
Time Frame
Baseline (enrollment visit) and after 2-week treatment phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Rudolf Briner, KD MD
Organizational Affiliation
ORL-Center, Clinic Hirslanden, Zurich, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic Hirslanden, ORL-Center
City
Zurich
State/Province
ZH
ZIP/Postal Code
8032
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
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