Sinuclean's Treatment Of Sinusitis' Symptoms

NCT00747747 | Completed Phase 4 Results

• 2 other identifiers: GAL-01-2007EudraCT: 2007-003739-22
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Sinusitis

Keywords

Sinusitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject

  After one week

• FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject

  After two weeks

• Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)

  After one week

• Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)

  After two weeks

Study Arms (3)

Control

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.

Saline solution

ACTIVE COMPARATOR

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

Biological: Saline solution

Sinuclean treatment

EXPERIMENTAL

Sinuclean DM Spray.

Device: Sinuclean DM Spray

Interventions

Saline solution BIOLOGICAL

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

Also known as: Libenar

Saline solution

Sinuclean DM Spray DEVICE

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

Also known as: Sinuclean DM Nasal Spray

Sinuclean treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galsor S.r.l.: lead

Study Sites (1)

University Cattolica del Sacro Cuore

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Clinical diagnosis could not be confirmed before treatment start due to logistics problems to make cranial MRI in due time.

Results Point of Contact

• Title: Dr. Sandro Soriano/Director of Clinical Trials
• Organization: Galsor s.r.l.

sandro.soriano@galsor.it

0039 0827 601723

Study Officials

• Gaetano Paludetti, MD

  University Cattolica del Sacro Cuore Roma Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2010
• Last Updated: March 14, 2012
• Results First Posted: March 14, 2012

Record last verified: 2012-03

Locations

IT (1)