Sinuclean's Treatment Of Sinusitis' Symptoms

Status Completed

Clinical Trial 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.

Clinical Trial 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". ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Sinusitis

Clinical Trial Details

NCT number	NCT00747747
Study type	Interventional
Source	Galsor S.r.l.
Contact
Status	Completed
Phase	Phase 4
Start date	November 2007
Completion date	February 2010

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sinuclean's Treatment Of Sinusitis' Symptoms — SToSS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms