TerminatedNot Applicable

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

Stopped: regulatory issues

Switzerland3 participantsStarted 2022-09-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of Sino-Nasal Outcome Test (SNOT) score from baseline

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

Trial details

NCT IDNCT05331222

SponsorJantar GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-03

View on ClinicalTrials.gov More Chronic Rhinitis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.