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

This study is ongoing, but not recruiting participants.

Sponsored by: Dey
Information provided by: Dey
ClinicalTrials.gov Identifier: NCT00552773
  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

MedlinePlus related topics:   Sinusitis   

ChemIDplus related topics:   Salicylsalicylic acid    Sodium salicylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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
Estimated Study Completion Date:   October 2008
Estimated Primary Completion Date:   August 2008 (Final data collection date for primary outcome measure)

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

  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

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

Show 25 study locations  Show 25 Study Locations

Sponsors and Collaborators
Dey

Investigators
Principal Investigator:     Angelique Barreto, MD     Memorial Clinical Reasearch, OK    
  More Information


Responsible Party:   Dey, LP ( Director, Clinical Affairs )
Study ID Numbers:   434-083
First Received:   October 31, 2007
Last Updated:   July 16, 2008
ClinicalTrials.gov Identifier:   NCT00552773
Health Authority:   United States: Food and Drug Administration

Keywords provided by Dey:
SINUSITIS  
CYCLAMEN  

Study placed in the following topic categories:
Acute Disease
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Salicylsalicylic acid
Sodium Salicylate
Sinusitis

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes
Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on October 07, 2008




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