Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhiniti⦠(NCT05331222) | Clinical Trial Compass
TerminatedNot Applicable
Proof-of-Concept Interventional Study With a Nasal Spray of JT-1 in Patients With Chronic Rhinitis or Chronic Sinusitis
Stopped: regulatory issues
Switzerland3 participantsStarted 2022-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Change of Sino-Nasal Outcome Test (SNOT) score from baseline
Timeframe: Baseline (enrollment visit) and after 2-week treatment phase