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

Completed · Not applicable · Has a placebo group

Conditions studied: ACUTE SINUSITIS

In brief

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

Key facts

Study ID

NCT00552773

Run by

Dey

People needed

48

Starts

2007-11-01

Expected to finish

2009-12-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Alliance Clinical Research — Birmingham, Alabama, United States
• Center of Research Excellence, LLC — Oxford, Alabama, United States
• Clinical Research Connections — Jonesboro, Arkansas, United States
• Southeast Clinical Research — Gainsville, Florida, United States
• Orlando Rangel, MD, PA — Tampa, Florida, United States
• Premier Health Research Center — Winter Haven, Florida, United States
• Peak Medical Research, LLC — Owensboro, Kentucky, United States
• Four Rivers Clinical Research, Inc. — Paducah, Kentucky, United States
• Las Vegas Physicians Research Group — Henderson, Nevada, United States
• LAND Clinical Studies, LLC — West Caldwell, New Jersey, United States
• Health Science Research Center — Cortland, New York, 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
• Jones Family Pratice — Shelby, North Carolina, United States
• Memorial Clinical Research — Oklahoma City, Oklahoma, United States
• Greenville Pharmaceutical Research — Greenville, South Carolina, United States
• ADAC Research, PA — Greenville, South Carolina, United States
• Carolina Research — Orangeberg, South Carolina, United States
• Austin Ear, Nose and Throat Clinic — Austin, Texas, United States
• West Lake Ffamily Practice/Time Point Clinical Research — Austin, Texas, United States
• San Antonio Ear, Nose & Throat Research — San Antonio, Texas, United States
• Live Oak Allergy and Asthma Clinic — San Antonio, Texas, United States
• Clinical Health Research LLC — Sugar Land, Texas, United States
• Wasatch Clinical Research, LLC — Salt Lake City, Utah, United States
• Virginia Adult and Pediatric Allergy and Asthma, PC — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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