Chronic Rhinitis, Chronic Sinus Congestion
Conditions
Keywords
rhinitis, sinusitis, rhinosinusitis
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
Interventions
DRUGJT-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.
Sponsors
Jantar GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm proof-of-concept study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Sino-Nasal Outcome Test (SNOT) score from baseline | Baseline (enrollment visit) and after 2-week treatment phase | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Peak Nasal Inspiratory Flow (PNIF) from baseline | Baseline (enrollment visit) and after 2-week treatment phase | The PNIF meter measures the nasal airway patency in L/min. |
| Change of Smell Diskettes Olfactory Test from baseline | Baseline (enrollment visit) and after 2-week treatment phase | Standardized 8-item odor (forced multiple choice) identification test (score of 0 to 8 correct answers) |
| Change of Visual Analog Scale (VAS) of Headache Intensity | Baseline (enrollment visit) and after 2-week treatment phase | 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. |
| Change of Visual Analog Scale (VAS) of Nasal Discomfort | Baseline (enrollment visit) and after 2-week treatment phase | 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. |
Countries
Switzerland
Outcome results
None listed