Sinuclean's Treatment Of Sinusitis' Symptoms

NCT ID: NCT00747747

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2010-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Saline solution

Saline solution sprayed according to the product indication. Only one brand/specific product has been selected.

Group Type: ACTIVE_COMPARATOR

Saline solution

Intervention Type: BIOLOGICAL

3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

Sinuclean treatment

Sinuclean DM Spray.

Group Type: EXPERIMENTAL

Sinuclean DM Spray

Intervention Type: DEVICE

3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

Interventions

Saline solution

3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed

Intervention Type: BIOLOGICAL

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

Intervention Type: DEVICE

Other Intervention Names

Libenar; Sinuclean DM Nasal Spray

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galsor S.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano Paludetti, MD

Role: PRINCIPAL_INVESTIGATOR

University Cattolica del Sacro Cuore Roma Italy

Locations

University Cattolica del Sacro Cuore

Rome, Lazio, Italy

Countries

Italy

Other Identifiers

EudraCT: 2007-003739-22

Identifier Type: OTHER

Identifier Source: secondary_id

GAL-01-2007

Identifier Type: -

Identifier Source: org_study_id