An interventional study of JT-1 in Chronic Rhinitis and Chronic Sinus Congestion, sponsored by Jantar GmbH. Terminated at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Jantar GmbH · Not applicable, Interventional, and Treatment
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
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 3 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →This is the only study on the registry with Jantar GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of medication during the last four weeks
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.
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
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.
Time frame: Baseline (enrollment visit) and after 2-week treatment phase
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.