Clinical trial NCT05331222: Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Official title: Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Rhinitis
Chronic Sinus Congestion
Keywords: rhinitis, sinusitis, rhinosinusitis
Lead sponsor: Jantar GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm proof-of-concept study
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change of Sino-Nasal Outcome Test (SNOT) score from baseline
timeFrame: Baseline (enrollment visit) and after 2-week treatment phase
Secondary outcomes:
measure: Change of Peak Nasal Inspiratory Flow (PNIF) from baseline
timeFrame: Baseline (enrollment visit) and after 2-week treatment phase
measure: Change of Smell Diskettes Olfactory Test from baseline
timeFrame: Baseline (enrollment visit) and after 2-week treatment phase
measure: Change of Visual Analog Scale (VAS) of Headache Intensity
timeFrame: Baseline (enrollment visit) and after 2-week treatment phase
measure: Change of Visual Analog Scale (VAS) of Nasal Discomfort
timeFrame: Baseline (enrollment visit) and after 2-week treatment phase
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic Hirslanden, ORL-Center
state: ZH
Study officials:
affiliation: ORL-Center, Clinic Hirslanden, Zurich, Switzerland
name: Hans Rudolf Briner, KD MD
role: PRINCIPAL_INVESTIGATOR
References: