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

NCT ID: NCT05331222

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-03-03

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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Jantar-1 (JT-1), 7% (w/w) aqueous solution

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.

Group Type: EXPERIMENTAL

JT-1

Intervention Type: DRUG

JT-1 is a physiological salt with recently detected pharmacological properties that warrant testing for its therapeutic potential in chronic rhinitis and chronic sinusitis.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jantar GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Rudolf Briner, KD MD

Role: PRINCIPAL_INVESTIGATOR

ORL-Center, Clinic Hirslanden, Zurich, Switzerland

Locations

Clinic Hirslanden, ORL-Center

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

BASEC 2021-00564

Identifier Type: -

Identifier Source: org_study_id