Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis

Official Title
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A Randomized, Double-blind, Placebo Controlled, Parallel Group Trial of Cyclamen Europaeum Extract Nasal Spray 10% (v/v) in the Treatment of Subjects With Acute Sinusitis

Conditions
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ACUTE SINUSITIS

Intervention / Treatment
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* Drug: Cyclamen Europaeum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18-70 Must be symptomatic on the basis of subject assessments of total sympton score. Evidence of mucopurulence on nasal endoscopy Evidence of inflammation upon nasal endoscopy CT scan with radiographic signs of acute sinusitis 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 Agree to abide by the study protocol and its restrictions Exclusion Criteria: Known history of hypogammaglobulinemia, immotile cilia syndrome, atrophic rhinitis, rhinitis medicamentosa, or cystic fibrosis Known hypersensitivity to Cyclamen, Primula, or other Primulaceae Serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease. Abnormal screening laboratory/imaging test results 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) Expansile mass or bony erosion on sinus radiograph Females who are pregnant, planning to become pregnant or currently breastfeeding. History of viral upper respiratory infection (URI) in the past 2 weeks Temperature greater than 102.5°F Facial or periorbital edema Local complications including orbital cellulitis; acute abnormalities of extraocular movements; cavernous vein thrombosis; dental or facial abscess Altered mental status Recent nasal or sinus surgery (within 3 months or less) or planned surgery within the next 3 months Use of intranasal antibiotics within the previous 30 days or systemic antibiotics within the previous 15 days Use of oral and/or topical nasal decongestants within the previous 7 days Had radiation therapy or chemotherapy within the previous 12 months Have used an investigational drug or device within 30 days prior to screening Have a history of illegal drug or alcohol abuse within the past 5 years 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cyclamen Europaeum<br> | Drug: Cyclamen Europaeum<br>* Nasal spray 10% (V/V),one spray per nostril daily for 7 days.<br>|
| Placebo Comparator: Placebo<br> | Drug: Cyclamen Europaeum<br>* Nasal spray 10% (V/V),one spray per nostril daily for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SINUSITIS, CYCLAMEN