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

Dey Pharma

Status: Completed

Conditions: ACUTE SINUSITIS

Treatments: Drug: Cyclamen Europaeum

Study type: Interventional

Funder types: Industry

Identifiers

NCT00552773

434-083

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 2 patient groups, including a placebo group

Cyclamen Europaeum

Experimental group

Treatment:

Drug: Cyclamen Europaeum

Placebo

Placebo Comparator group

Treatment:

Drug: Cyclamen Europaeum