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: May 31, 2013
Last verified: November 2011
  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:


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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 31, 2013
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 July 24, 2014