Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
- Conditions
- ACUTE SINUSITIS
- Interventions
- Drug: Cyclamen Europaeum
- Registration Number
- NCT00552773
- Lead Sponsor
- Dey
- Brief Summary
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cyclamen Europaeum Cyclamen Europaeum - Placebo Cyclamen Europaeum -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (25)
Peak Medical Research, LLC
🇺🇸Owensboro, Kentucky, United States
West Lake Ffamily Practice/Time Point Clinical Research
🇺🇸Austin, Texas, United States
LAND Clinical Studies, LLC
🇺🇸West Caldwell, New Jersey, United States
Las Vegas Physicians Research Group
🇺🇸Henderson, Nevada, United States
Medical Research Associates of Central ew York, PLLC
🇺🇸North Syracuse, New York, United States
American Institute of Healthcare and Fitness Clinical Research
🇺🇸Raleigh, North Carolina, United States
ADAC Research, PA
🇺🇸Greenville, South Carolina, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Clinical Health Research LLC
🇺🇸Sugar Land, Texas, United States
Premier Health Research Center
🇺🇸Winter Haven, Florida, United States
Clinical Research Connections
🇺🇸Jonesboro, Arkansas, United States
Alliance Clinical Research
🇺🇸Birmingham, Alabama, United States
Austin Ear, Nose and Throat Clinic
🇺🇸Austin, Texas, United States
Southeast Clinical Research
🇺🇸Gainsville, Florida, United States
Memorial Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
San Antonio Ear, Nose & Throat Research
🇺🇸San Antonio, Texas, United States
Live Oak Allergy and Asthma Clinic
🇺🇸San Antonio, Texas, United States
Wasatch Clinical Research, LLC
🇺🇸Salt Lake City, Utah, United States
Center of Research Excellence, LLC
🇺🇸Oxford, Alabama, United States
Orlando Rangel, MD, PA
🇺🇸Tampa, Florida, United States
Carolina Research
🇺🇸Orangeberg, South Carolina, United States
Health Science Research Center
🇺🇸Cortland, New York, United States
Jones Family Pratice
🇺🇸Shelby, North Carolina, United States
Greenville Pharmaceutical Research
🇺🇸Greenville, South Carolina, United States
Virginia Adult and Pediatric Allergy and Asthma, PC
🇺🇸Richmond, Virginia, United States