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

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jantar GmbH

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