Chronic RhinitisNCT05331222
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
A study testing JT-1 in people with Chronic Rhinitis and Chronic Sinus Congestion, run by Jantar GmbH at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinitis, Chronic Sinus Congestion
- What is being tested?
- JT-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Sep 2022to 3 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Patient needs O2 substitution
- Patient has cystic fibrosis
- Patient has primary ciliary dyskinesia
- Patient is demented or otherwise incapable of judgement
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic Hirslanden, ORL-Center
Zurich, Canton of Zurich, 8032
About this study
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.
Read the 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
- Conditions
- Chronic Rhinitis, Chronic Sinus Congestion
- Being tested
- JT-1
- Keywords
- rhinitis, sinusitis, rhinosinusitis
- Medical subject headings
- Rhinitis, Sinusitis, Rhinosinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: JT-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (enrollment visit) and after 2-week treatment phase
Secondary outcomes (4)
Change of Peak Nasal Inspiratory Flow (PNIF) from baseline
The PNIF meter measures the nasal airway patency in L/min.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Baseline (enrollment visit) and after 2-week treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start30 Sep 2022
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Why it stopped: regulatory issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm proof-of-concept study
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jantar GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans Rudolf Briner, KD MD, Principal investigator, ORL-Center, Clinic Hirslanden, Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331222
- Sponsor's protocol ID
- BASEC 2021-00564
- Status last verified
- Mar 2023
- First submitted
- 7 Apr 2022
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT05331222
- Acronym / sponsor ID
- BASEC 2021-00564
- Conditions
- Chronic Rhinitis, Chronic Sinus Congestion
- Keywords
- rhinitis, sinusitis, rhinosinusitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: regulatory issues
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Jantar GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm proof-of-concept study
| Arm | Type | Receives |
|---|---|---|
| Jantar-1 (JT-1), 7% (w/w) aqueous solution | Experimental | Drug: JT-1Dosing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (10 listed)
- Severely purulent forms of sinusitis
- History of medication during the last four weeks
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JT-1JT-1 is a physiological salt with recently detected pharmacological properties that warrant testing for its therapeutic potential in chronic rhinitis and chronic sinusitis. | Drug | Jantar-1 (JT-1), 7% (w/w) aqueous solution |
Primary outcome
Change of Sino-Nasal Outcome Test (SNOT) score from baseline
Time frame: Baseline (enrollment visit) and after 2-week treatment phase
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)
4 secondary outcomes
Change of Peak Nasal Inspiratory Flow (PNIF) from baseline
Time frame: Baseline (enrollment visit) and after 2-week treatment phase
Change of Smell Diskettes Olfactory Test from baseline
Time frame: Baseline (enrollment visit) and after 2-week treatment phase
Change of Visual Analog Scale (VAS) of Headache Intensity
Time frame: Baseline (enrollment visit) and after 2-week treatment phase
Change of Visual Analog Scale (VAS) of Nasal Discomfort
Time frame: Baseline (enrollment visit) and after 2-week treatment phase
Results and safety
The study was stopped early (reason given: regulatory issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
Related trials for Chronic Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
RecruitingObservational study
The Epidemiological and Intrinsic Characteristics of Chronic Rhinitis
Chronic Rhinitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Rudolf Briner, KD MD principal investigator
ORL-Center, Clinic Hirslanden, Zurich, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JT-1 in people with Chronic Rhinitis and Chronic Sinus Congestion, run by Jantar GmbH at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: regulatory issues). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Sino-Nasal Outcome Test (SNOT) score from baseline (time frame: Baseline (enrollment visit) and after 2-week treatment phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.