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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552773
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : June 4, 2013
Information provided by (Responsible Party):

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
ACUTE SINUSITIS Drug: Cyclamen Europaeum Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis

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.

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. [ Time Frame: 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 [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552773

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Sponsors and Collaborators
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Principal Investigator: Angelique Barreto, MD Memorial Clinical Reasearch, OK
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Responsible Party: Dey Identifier: NCT00552773    
Other Study ID Numbers: 434-083
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: November 2011
Keywords provided by Dey:
Additional relevant MeSH terms:
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Acute Disease
Respiratory Tract Infections
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes