Sinusitis Clinical Trial
— SToSSOfficial 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.
Verified date | March 2012 |
Source | Galsor S.r.l. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: The Italian Medicines Agency |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | February 2010 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 DMĀ® - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University Cattolica del Sacro Cuore | Rome | Lazio |
Lead Sponsor | Collaborator |
---|---|
Galsor S.r.l. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | Yes |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03584178 -
The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT06016335 -
MRI-based Synthetic CT Images of the Head and Neck
|
N/A | |
Active, not recruiting |
NCT02278484 -
Sinus Balloon Dilation in Pediatric Patients
|
N/A | |
Withdrawn |
NCT02071667 -
Association of Periostin Levels and Chronic Sinusitis
|
N/A | |
Completed |
NCT01420471 -
Medicated Punctured-Glove-Finger Spacer Study
|
Phase 4 | |
Completed |
NCT01118312 -
Study of Asthma and Nasal Steroids
|
Phase 4 | |
Completed |
NCT00645762 -
Balloon REmodeling Antrostomy THErapy Study
|
Phase 2 | |
Completed |
NCT01685229 -
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
|
||
Active, not recruiting |
NCT03943121 -
The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps
|
N/A | |
Withdrawn |
NCT02900794 -
Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery
|
N/A | |
Terminated |
NCT02630472 -
Topical Irrigation Therapy for CRS
|
Phase 1/Phase 2 | |
Completed |
NCT01442740 -
15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients
|
N/A | |
Completed |
NCT01001039 -
Validation of the Facial and Cephalic Pain Inventory
|
N/A | |
Completed |
NCT01033799 -
Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers
|
N/A | |
Completed |
NCT00242437 -
Hemostatic Matrix in Endoscopic Sinus Surgery
|
Phase 4 | |
Completed |
NCT00335309 -
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis
|
N/A | |
Completed |
NCT00236522 -
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
|
Phase 3 | |
Completed |
NCT01717274 -
Hot Saline Irrigation Study
|
N/A | |
Completed |
NCT01166945 -
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children
|
N/A | |
Not yet recruiting |
NCT00545961 -
Middle Meatal Bacteriology During Acute Respiratory Infection in Children
|
Phase 4 |