Sinuclean's Treatment Of Sinusitis' Symptoms (SToSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galsor S.r.l.
ClinicalTrials.gov Identifier:
NCT00747747
First received: September 4, 2008
Last updated: March 12, 2012
Last verified: March 2012
  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
Biological: Saline solution
Device: Sinuclean DM Spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) [ Time Frame: After one week ] [ Designated as safety issue: No ]
    Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)

  • Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) [ Time Frame: After two weeks ] [ Designated as safety issue: Yes ]
    Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)


Secondary Outcome Measures:
  • FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject [ Time Frame: After one week ] [ Designated as safety issue: No ]
    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

  • FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject [ Time Frame: After two weeks ] [ Designated as safety issue: No ]
    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.

  • Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) [ Time Frame: After one week ] [ Designated as safety issue: No ]
    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.

  • Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) [ Time Frame: After two weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: November 2007
Study Completion Date: February 2010
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sinuclean DM Nasal 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".

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
University Cattolica del Sacro Cuore
Rome, Lazio, Italy, 00168
Sponsors and Collaborators
Galsor S.r.l.
Investigators
Principal Investigator: Gaetano Paludetti, MD University Cattolica del Sacro Cuore Roma Italy
  More Information

Additional Information:
No publications provided

Responsible Party: Galsor S.r.l.
ClinicalTrials.gov Identifier: NCT00747747     History of Changes
Other Study ID Numbers: GAL-01-2007, EudraCT: 2007-003739-22
Study First Received: September 4, 2008
Results First Received: December 5, 2011
Last Updated: March 12, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Galsor S.r.l.:
Sinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Pharmaceutical Solutions
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014