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
1 other identifier
interventional
48
1 country
25
Brief Summary
To evaluate the efficacy and safety of Cyclamen europaeum extract 10 % (v/v) compared to placebo in subjects with acute sinusitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2007
Typical duration for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedFirst Posted
Study publicly available on registry
November 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 4, 2013
November 1, 2011
10 months
October 31, 2007
May 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (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
Study Arms (2)
Cyclamen Europaeum
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Eligibility Criteria
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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deylead
Study Sites (25)
Alliance Clinical Research
Birmingham, Alabama, 35215, United States
Center of Research Excellence, LLC
Oxford, Alabama, 36206, United States
Clinical Research Connections
Jonesboro, Arkansas, 72401, United States
Southeast Clinical Research
Gainsville, Florida, 32601, United States
Orlando Rangel, MD, PA
Tampa, Florida, 33607, United States
Premier Health Research Center
Winter Haven, Florida, 33880, United States
Peak Medical Research, LLC
Owensboro, Kentucky, 42303, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Las Vegas Physicians Research Group
Henderson, Nevada, 89052, United States
LAND Clinical Studies, LLC
West Caldwell, New Jersey, 07006, United States
Health Science Research Center
Cortland, New York, 13045, United States
Medical Research Associates of Central ew York, PLLC
North Syracuse, New York, 13212, United States
American Institute of Healthcare and Fitness Clinical Research
Raleigh, North Carolina, 27615, United States
Jones Family Pratice
Shelby, North Carolina, 28150, United States
Memorial Clinical Research
Oklahoma City, Oklahoma, 73134, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, 28615, United States
ADAC Research, PA
Greenville, South Carolina, 29607, United States
Carolina Research
Orangeberg, South Carolina, 29118, United States
Austin Ear, Nose and Throat Clinic
Austin, Texas, 78707, United States
West Lake Ffamily Practice/Time Point Clinical Research
Austin, Texas, 78746, United States
San Antonio Ear, Nose & Throat Research
San Antonio, Texas, 78229, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, 78233, United States
Clinical Health Research LLC
Sugar Land, Texas, 77479, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107, United States
Virginia Adult and Pediatric Allergy and Asthma, PC
Richmond, Virginia, 23229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angelique Barreto, MD
Memorial Clinical Reasearch, OK
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2007
First Posted
November 2, 2007
Study Start
November 1, 2007
Primary Completion
September 1, 2008
Study Completion
December 1, 2009
Last Updated
June 4, 2013
Record last verified: 2011-11