Sinuclean's Treatment Of Sinusitis' Symptoms
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Saline solution; Sinuclean DM Spray
Intervention description: 3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed; 3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sinusitis

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.
    

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.