Back to resultsSinuclean's Treatment Of Sinusitis' Symptoms (SToSS)
Primary Purpose
Sinusitis
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Saline solution
Sinuclean DM Spray
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis focused on measuring Sinusitis
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.
Sites / Locations
- University Cattolica del Sacro Cuore
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Control
Saline solution
Sinuclean treatment
Arm Description
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 sprayed according to the product indication. Only one brand/specific product has been selected.
Sinuclean DM Spray.
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
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
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00747747
Brief Title
Sinuclean's Treatment Of Sinusitis' Symptoms
Acronym
SToSS
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galsor S.r.l.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
= mild symptom: clearly perceptible, but easily tolerated
= moderate symptom: clear awareness of the symptom, that is annoying but tolerable
= 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".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Saline solution
Arm Type
Active Comparator
Arm Description
Saline solution sprayed according to the product indication. Only one brand/specific product has been selected.
Arm Title
Sinuclean treatment
Arm Type
Experimental
Arm Description
Sinuclean DM Spray.
Intervention Type
Biological
Intervention Name(s)
Saline solution
Other Intervention Name(s)
Libenar
Intervention Description
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
Intervention Name(s)
Sinuclean DM Spray
Other Intervention Name(s)
Sinuclean DM Nasal 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
Primary Outcome Measure Information:
Title
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
Description
Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients)
Time Frame
After one week
Title
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
Description
Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)
Time Frame
After two weeks
Secondary Outcome Measure Information:
Title
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
Description
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
Time Frame
After one week
Title
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
Description
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.
Time Frame
After two weeks
Title
Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)
Description
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.
Time Frame
After one week
Title
Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)
Description
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.
Time Frame
After two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Paludetti, MD
Organizational Affiliation
University Cattolica del Sacro Cuore Roma Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Cattolica del Sacro Cuore
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
12. IPD Sharing Statement
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Sinuclean's Treatment Of Sinusitis' Symptoms
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