ACUTE SINUSITIS
Conditions
Keywords
SINUSITIS, CYCLAMEN
Brief summary
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
Interventions
DRUGCyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Sponsors
Dey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Adults age 18-70 2. Must be symptomatic on the basis of subject assessments of total sympton score. 3. Evidence of mucopurulence on nasal endoscopy 4. Evidence of inflammation upon nasal endoscopy 5. CT scan with radiographic signs of acute sinusitis 6. Able to complete all study activities or procedures through the end of the study, including all visits and tests, and capable of selfadministration of study medication 7. Agree to abide by the study protocol and its restrictions
Exclusion criteria
1. Known history of hypogammaglobulinemia, immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa, or cystic fibrosis 2. Known hypersensitivity to Cyclamen, Primula, or other Primulaceae 3. Serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease. 4. Abnormal screening laboratory/imaging test results 5. Condition(s) that compromise the ability to either administer the agent or assess the risks/benefits (eg mucocele, choanal polyp, Stage 4 polyposis or cyst extending below the inferior turbinate, deviated septum, facial trauma, or birth defect) 6. Expansile mass or bony erosion on sinus radiograph 7. Females who are pregnant, planning to become pregnant or currently breastfeeding. 8. History of viral upper respiratory infection (URI) in the past 2 weeks 9. Temperature greater than 102.5°F 10. Facial or periorbital edema 11. Local complications including orbital cellulitis; acute abnormalities of extraocular movements; cavernous vein thrombosis; dental or facial abscess 12. Altered mental status 13. Recent nasal or sinus surgery (within 3 months or less) or planned surgery within the next 3 months 14. Use of intranasal antibiotics within the previous 30 days or systemic antibiotics within the previous 15 days 15. Use of oral and/or topical nasal decongestants within the previous 7 days 16. Had radiation therapy or chemotherapy within the previous 12 months 17. Have used an investigational drug or device within 30 days prior to screening 18. Have a history of illegal drug or alcohol abuse within the past 5 years 19. Have major unstable organ system disease that could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives Subjects who have asthma, seasonal and/or perennial allergic rhinitis will be allowed to enter the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| TSS change from Baseline to each post-dose visit for each symptom scoring Change from Baseline for the individual symptom scores Time to cure rate Frequency of acute sinusitis episodes The presence/absence of mucopurulence and inflamed nasal mucosa | 1 year |
Countries
United States
Outcome results
None listed