Clinical trial NCT00552773: Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ACUTE SINUSITIS
Keywords: SINUSITIS
CYCLAMEN
Lead sponsor: Dey
Sponsor class: INDUSTRY
First posted: 2007-11-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans.
timeFrame: 1 year
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alliance Clinical Research
state: Alabama
city: Oxford
country: United States
facility: Center of Research Excellence, LLC
state: Alabama
city: Jonesboro
country: United States
facility: Clinical Research Connections
state: Arkansas
city: Gainsville
country: United States
facility: Southeast Clinical Research
state: Florida
city: Tampa
country: United States
facility: Orlando Rangel, MD, PA
state: Florida
city: Winter Haven
country: United States
facility: Premier Health Research Center
state: Florida
city: Owensboro
country: United States
facility: Peak Medical Research, LLC
state: Kentucky
city: Paducah
country: United States
facility: Four Rivers Clinical Research, Inc.
state: Kentucky
city: Henderson
country: United States
facility: Las Vegas Physicians Research Group
state: Nevada
city: West Caldwell
country: United States
facility: LAND Clinical Studies, LLC
state: New Jersey
city: Cortland
country: United States
facility: Health Science Research Center
state: New York
city: North Syracuse
country: United States
facility: Medical Research Associates of Central ew York, PLLC
state: New York
city: Raleigh
country: United States
facility: American Institute of Healthcare and Fitness Clinical Research
state: North Carolina
city: Shelby
country: United States
facility: Jones Family Pratice
state: North Carolina
city: Oklahoma City
country: United States
facility: Memorial Clinical Research
state: Oklahoma
city: Greenville
country: United States
facility: Greenville Pharmaceutical Research
state: South Carolina
city: Greenville
country: United States
facility: ADAC Research, PA
state: South Carolina
city: Orangeberg
country: United States
facility: Carolina Research
state: South Carolina
city: Austin
country: United States
facility: Austin Ear, Nose and Throat Clinic
state: Texas
city: Austin
country: United States
facility: West Lake Ffamily Practice/Time Point Clinical Research
state: Texas
city: San Antonio
country: United States
facility: San Antonio Ear, Nose & Throat Research
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy and Asthma Clinic
state: Texas
city: Sugar Land
country: United States
facility: Clinical Health Research LLC
state: Texas
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research, LLC
state: Utah
city: Richmond
country: United States
facility: Virginia Adult and Pediatric Allergy and Asthma, PC
state: Virginia
Study officials:
affiliation: Memorial Clinical Reasearch, OK
name: Angelique Barreto, MD
role: PRINCIPAL_INVESTIGATOR
References: