ACUTE SINUSITIS Clinical Trial
Official title:
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
Verified date | November 2011 |
Source | Dey |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
Status | Completed |
Enrollment | 48 |
Est. completion date | December 2009 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Austin Ear, Nose and Throat Clinic | Austin | Texas |
United States | West Lake Ffamily Practice/Time Point Clinical Research | Austin | Texas |
United States | Alliance Clinical Research | Birmingham | Alabama |
United States | Health Science Research Center | Cortland | New York |
United States | Southeast Clinical Research | Gainsville | Florida |
United States | ADAC Research, PA | Greenville | South Carolina |
United States | Greenville Pharmaceutical Research | Greenville | South Carolina |
United States | Las Vegas Physicians Research Group | Henderson | Nevada |
United States | Clinical Research Connections | Jonesboro | Arkansas |
United States | Medical Research Associates of Central ew York, PLLC | North Syracuse | New York |
United States | Memorial Clinical Research | Oklahoma City | Oklahoma |
United States | Carolina Research | Orangeberg | South Carolina |
United States | Peak Medical Research, LLC | Owensboro | Kentucky |
United States | Center of Research Excellence, LLC | Oxford | Alabama |
United States | Four Rivers Clinical Research, Inc. | Paducah | Kentucky |
United States | American Institute of Healthcare and Fitness Clinical Research | Raleigh | North Carolina |
United States | Virginia Adult and Pediatric Allergy and Asthma, PC | Richmond | Virginia |
United States | Wasatch Clinical Research, LLC | Salt Lake City | Utah |
United States | Live Oak Allergy and Asthma Clinic | San Antonio | Texas |
United States | San Antonio Ear, Nose & Throat Research | San Antonio | Texas |
United States | Jones Family Pratice | Shelby | North Carolina |
United States | Clinical Health Research LLC | Sugar Land | Texas |
United States | Orlando Rangel, MD, PA | Tampa | Florida |
United States | LAND Clinical Studies, LLC | West Caldwell | New Jersey |
United States | Premier Health Research Center | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Dey |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | 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 | No |
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