NCT00747747

Sinuclean's Treatment Of Sinusitis' Symptoms

Safety and Efficacy (for Symptoms Remission) of the Treatment of the Acute Episode of Sinusitis With Ecballium Elaterium (SINUclean DM® Nasal Spray) as Co-adjuvant of the Antibiotic Therapy: Comparative, Prospective, Randomized, Open Study.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Galsor S.r.l. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of the study is to demonstrate that SINUclean DM® spray, added to the standard (amoxicillin/clavulanate) therapy of the acute episode of sinusitis (acute, subacute or chronic), is safe ad capable to determine the resolution of the symptoms in a shorter time in comparison with the standard therapy without co-adjuvant, or with simple saline lavage.

Detailed description

The randomized subject with diagnosis of acute episode of sinusitis with symptoms and mucus in the paranasal sinuses, will treat his/her condition with background amoxicillin/clavulanate and with inhalation of Sinuclean or Saline, while the control group will not use any spray for symptom relief. Anti-histaminic, steroidal anti-inflammatory drugs are forbidden. The patient is requested to evaluate his state of symptoms by recording in a diary * the pain or feeling of facial oppression; * nasal dripping anterior or posterior; * nasal congestion. SCALE 0 = no symptom 1. = mild symptom: clearly perceptible, but easily tolerated 2. = moderate symptom: clear awareness of the symptom, that is annoying but tolerable 3. = severe: symptom very annoying, difficult to tolerate, interfering with the ordinary life Four measures per day (2 for administration of the therapy - before/after) of which the median will be used; plus an evening measure "retrospective" of the past 12 hours. If possible it will be assessed the status of paranasal sinuses before and after the treatment with a CT scan. The treatment intervals is the week. After baseline and start of treatment, are planned two control visit. The subject will complete the study at the first control visit without symptoms. After the second visit, if the symptoms are still present, the subject will complete as a "treatment-failure".

Conditions

• Sinusitis

Interventions

Type	Name	Description
BIOLOGICAL	Saline solution	3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
DEVICE	Sinuclean DM Spray	3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-01-01
• Completion: 2010-02-01
• First posted: 2008-09-05
• Last updated: 2012-03-14
• Results posted: 2012-03-14

Locations

1 site across 1 country: Italy