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

Sponsor
Dey (Industry)
Overall Status
Completed
CT.gov ID
NCT00552773
Collaborator
(none)
48
Enrollment
25
Locations
2
Arms
25
Duration (Months)
1.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Cyclamen Europaeum
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Sep 1, 2008
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cyclamen Europaeum

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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Dey

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dey
ClinicalTrials.gov Identifier:
NCT00552773
Other Study ID Numbers:
  • 434-083
First Posted:
Nov 2, 2007
Last Update Posted:
Jun 4, 2013
Last Verified:
Nov 1, 2011
Keywords provided by Dey
SINUSITIS
CYCLAMEN
Additional relevant MeSH terms:
Sinusitis
Acute Disease

Study Results

No Results Posted as of Jun 4, 2013