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

Chronic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05331222
• Other study ID #: BASEC 2021-00564
• Status: Terminated
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: March 3, 2023

Study information

• Verified date: March 2023
• Source: Jantar GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Rhinitis
• Chronic Sinus Congestion
• Rhinitis
• Sinusitis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Switzerland	Clinic Hirslanden, ORL-Center	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
Jantar GmbH

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline (enrollment visit) and after 2-week treatment phase
Secondary	Change of Peak Nasal Inspiratory Flow (PNIF) from baseline	The PNIF meter measures the nasal airway patency in L/min.	Baseline (enrollment visit) and after 2-week treatment phase
Secondary	Change of Smell Diskettes Olfactory Test from baseline	Standardized 8-item odor (forced multiple choice) identification test (score of 0 to 8 correct answers)	Baseline (enrollment visit) and after 2-week treatment phase
Secondary	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.	Baseline (enrollment visit) and after 2-week treatment phase
Secondary	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.	Baseline (enrollment visit) and after 2-week treatment phase