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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dey

ClinicalTrials.gov Identifier:

NCT00552773

First received: October 31, 2007

Last updated: November 10, 2011

Last verified: November 2011

History of Changes

Purpose

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

Condition	Intervention
ACUTE SINUSITIS	Drug: Cyclamen Europaeum

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis

U.S. FDA Resources

Further study details as provided by Dey:

Primary Outcome Measures:

Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	48
Study Start Date:	November 2007
Study Completion Date:	December 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Had radiation therapy or chemotherapy within the previous 12 months
Have used an investigational drug or device within 30 days prior to screening
Have a history of illegal drug or alcohol abuse within the past 5 years
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552773

Show 25 Study Locations

Sponsors and Collaborators

Dey

Investigators

Principal Investigator:

Angelique Barreto, MD

Memorial Clinical Reasearch, OK

More Information

No publications provided

Responsible Party:	Dey
ClinicalTrials.gov Identifier:	NCT00552773 History of Changes
Other Study ID Numbers:	434-083
Study First Received:	October 31, 2007
Last Updated:	November 10, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dey:

SINUSITIS
CYCLAMEN

Additional relevant MeSH terms:

Sinusitis
Acute Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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