Status:
TERMINATED
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Lead Sponsor:
Jantar GmbH
Conditions:
Chronic Rhinitis
Chronic Sinus Congestion
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05331222
Start Date
September 30 2022
End Date
March 3 2023
Last Update
March 21 2023
Active Locations (1)
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1
Clinic Hirslanden, ORL-Center
Zurich, Canton of Zurich, Switzerland, 8032