Sinuclean's Treatment Of Sinusitis' Symptoms (SToSS)

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.

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Biological: Saline solution; Device: Sinuclean DM Spray

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".

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • University Cattolica del Sacro Cuore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Active Comparator: Saline solution; Saline solution sprayed according to the product indication. Only one brand/specific product has been selected.	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; Other Names: Libenar
Experimental: Sinuclean treatment; Sinuclean DM Spray.	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; Other Names: Sinuclean DM Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)	Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)	After one week
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)	Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)	After two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject	Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank "0" were compared as outcome measure between groups	After one week
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject	Patient's daily diary retrospective ranked assessment of symptoms (0,1,2,3 with 0 = no symptoms; frequencies of patients with rank "0" were compared as outcome measure between groups.	After two weeks
Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)	Clinical assessment of healing of the sinusitis episode(Outcome Measure Percentage of patients healed). Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.	After one week
Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)	Clinical assessment of healing of the sinusitis episode (Outcome Measure Percentage of patients healed. Healing was assessed clinically by the physician as recovery of the condition prior to the diagnosis of the episode of sinusitis, without need of medical treatment.	After two weeks

Collaborators and Investigators

• Sponsor: Galsor S.r.l.
• Investigators: Principal Investigator: Gaetano Paludetti, MD, University Cattolica del Sacro Cuore Roma Italy

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: September 4, 2008
• First Submitted That Met QC Criteria: September 4, 2008
• First Posted (Estimate): September 5, 2008

Study Record Updates

• Last Update Posted (Estimate): March 14, 2012
• Last Update Submitted That Met QC Criteria: March 12, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Sinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: GAL-01-2007; EudraCT: 2007-003739-22 (Other Identifier: Sponsor Galsor srl)