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

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

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

Study Overview

• Status: Completed
• Conditions: ACUTE SINUSITIS
• Intervention / Treatment: Drug: Cyclamen Europaeum

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35215
      • Alliance Clinical Research
    • Oxford, Alabama, United States, 36206
      • Center of Research Excellence, LLC
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Clinical Research Connections
  • Florida
    • Gainsville, Florida, United States, 32601
      • Southeast Clinical Research
    • Tampa, Florida, United States, 33607
      • Orlando Rangel, MD, PA
    • Winter Haven, Florida, United States, 33880
      • Premier Health Research Center
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Peak Medical Research, LLC
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research, Inc.
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Las Vegas Physicians Research Group
  • New Jersey
    • West Caldwell, New Jersey, United States, 07006
      • LAND Clinical Studies, LLC
  • New York
    • Cortland, New York, United States, 13045
      • Health Science Research Center
    • North Syracuse, New York, United States, 13212
      • Medical Research Associates of Central ew York, PLLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27615
      • American Institute of Healthcare and Fitness Clinical Research
    • Shelby, North Carolina, United States, 28150
      • Jones Family Pratice
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Memorial Clinical Research
  • South Carolina
    • Greenville, South Carolina, United States, 29607
      • ADAC research, PA
    • Greenville, South Carolina, United States, 28615
      • Greenville Pharmaceutical Research
    • Orangeberg, South Carolina, United States, 29118
      • Carolina Research
  • Texas
    • Austin, Texas, United States, 78707
      • Austin Ear, Nose and Throat Clinic
    • Austin, Texas, United States, 78746
      • West Lake Ffamily Practice/Time Point Clinical Research
    • San Antonio, Texas, United States, 78229
      • San Antonio Ear, Nose & Throat Research
    • San Antonio, Texas, United States, 78233
      • Live Oak Allergy and Asthma Clinic
    • Sugar Land, Texas, United States, 77479
      • Clinical Health Research LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research, LLC
  • Virginia
    • Richmond, Virginia, United States, 23229
      • Virginia Adult and Pediatric Allergy and Asthma, PC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Cyclamen Europaeum; Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Experimental: Cyclamen Europaeum	Drug: Cyclamen Europaeum; Nasal spray 10% (V/V),one spray per nostril daily for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dey
• Investigators: Principal Investigator: Angelique Barreto, MD, Memorial Clinical Reasearch, OK

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: October 31, 2007
• First Submitted That Met QC Criteria: October 31, 2007
• First Posted (Estimate): November 2, 2007

Study Record Updates

• Last Update Posted (Estimate): June 4, 2013
• Last Update Submitted That Met QC Criteria: May 31, 2013
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: SINUSITIS; CYCLAMEN
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Disease Attributes; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Acute Disease
• Other Study ID Numbers: 434-083