Sinuclean's Treatment Of Sinusitis' Symptoms - Full Text View

Sponsored by:	Galsor S.r.l.
Information provided by:	Galsor S.r.l.
ClinicalTrials.gov Identifier:	NCT00747747

Purpose

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.

Condition	Intervention	Phase
Sinusitis	Drug: Saline solution Drug: Sinuclean DM Spray	Phase IV

MedlinePlus related topics: Antibiotics Sinusitis

Drug Information available for: Sodium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Galsor S.r.l.:

Primary Outcome Measures:

Percentage of sinusitis symptoms recovery following use of co-adjuvant treatment, specifically for those symptoms associated with the presence of the mucus in the para-nasal sinuses. [ Time Frame: One and two weeks of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to recovery for those symptoms associated with the presence of the mucus in the sinuses: pain or sensation of facial oppression, nasal mucus dripping, nasal congestion, presence of pain when pressure is made on the zones of the facial pain. [ Time Frame: One and two weeks of treatment. ] [ Designated as safety issue: No ]
Percentage and time of clinical recovery of the acute episode of sinusitis, following the addition of the co-adjuvant treatment to the antibiotic therapy [ Time Frame: One or two weeks of treatment. ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	November 2007
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention No coadiuvant treatment. The subject is treated with the antibiotic only and forbidden to take any coadiuvant medicine as a remedy for the symptoms during the period of the study.
2: Active Comparator Saline solution sprayed according to the product indication. Only one brand/specific product has been selected.	Drug: Saline solution 3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
3: Experimental Sinuclean DM Spray.	Drug: 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

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".

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female sex.
Age > 18 years old.
Diagnosis of acute episode of sinusitis (in an acute, subacute or chronic background), confirmed with a CT scan image.
Presence of mucus in para-nasal sinuses.
Symptoms of facial pain associated to the congestion of the mucosa of the paranasal sinuses for at least three days.
Written informed consent.
Expressed intention of compliance with the study requirements.

Exclusion Criteria:

In case of female subject: ongoing pregnancy or lactating; or condition of fecundity without abstinence.
Assumption, during the study, of drugs that can interfere with the evaluation of the investigational drug (see Section "Concomitant Therapy")
Possible necessity of treatment, during the study, with drugs that are not allowed (see section "Concomitant Therapy").
Clinical conditions (systemic pathologies or other) that can interfere with the assessment of the safety and efficacy of the investigational drug, in example: viral or allergic rhinitis with active secretive symptomatology, presence of visible nasal polyps, diagnosis of immobile cilia syndrome, diseases determining immunodeficiency cystic fibrosis immunocompromission renal insufficiency, dialysis, pathology of other apparatus that, in the opinion of the investigator, necessity of a supplementary antibiotic therapy,due to other pathologies, besides the one standard of the sinusitis.
Psychical conditions not compatible with the participation to the clinical trial.
Alcohol abuse or other dependencies on stupefacents
Smoking during the period of the study
History of intolerance or allergy to the components of SINUclean DM®
Surgical or medical intervention that can jeopardize the complete performance of the trial, in the 4 wks preceding the administration of the informed consent
Planning of a surgical or medical intervention that can jeopardize the completion of the trial
Participation to other clinical trials, ongoing or terminated since less than 30 days before the beginning of the present experiment.
Preceding randomization in this trial.
Be component of the investigators' staff or be a relative of a member of the staff.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747747

Locations

Italy, Lazio
University Cattolica del Sacro Cuore	Recruiting
Rome, Lazio, Italy, 00168
Contact: Luigi Corina, MD 00390630154439 iclot@rm.unicatt.it
Principal Investigator: Gaetano Paludetti, MD
Sub-Investigator: Luigi Corina, MD
Italy, Toscana
University Dipartimento di Neuroscienze - Sezione Otorinolaringoiatria	Recruiting
Pisa, Toscana, Italy, 56126
Contact: Giovanni Segnini, MD 00390509926302625 t.pardini@neuro.med.unipi.it
Principal Investigator: Stefano Sellari Franceschini, MD
Sub-Investigator: Giovanni Segnini, MD

Sponsors and Collaborators

Galsor S.r.l.

Investigators

Principal Investigator:

Gaetano Paludetti, MD

University Cattolica del Sacro Cuore Roma Italy

More Information

Sponsor

This link exits the ClinicalTrials.gov site

Responsible Party:	Galsor S.r.l. ( Prof. Sandro Soriano )
Study ID Numbers:	GAL-01-2007, EudraCT: 2007-003739-22
Study First Received:	September 4, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00747747
Health Authority:	Italy: The Italian Medicines Agency

Keywords provided by Galsor S.r.l.:

Sinusitis

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Sinusitis

Additional relevant MeSH terms:

Paranasal Sinus Diseases
Nose Diseases

ClinicalTrials.gov processed this record on January 14, 2009