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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552773
• Other study ID #: 434-083
• Status: Completed
• Phase: N/A
• First received: October 31, 2007
• Last updated: May 31, 2013
• Start date: November 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2011
• Source: Dey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Disease
• ACUTE SINUSITIS
• Sinusitis

Intervention

Drug:
• Cyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Dey

Country where clinical trial is conducted

United States, 

Outcome

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