SinusitisPhase 4SToSSNCT00747747
Sinuclean's Treatment Of Sinusitis' Symptoms
A Phase 4 study testing Saline solution and Sinuclean DM Spray in people with Sinusitis, run by Galsor S.r.l. at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- What is being tested?
- Saline solution and Sinuclean DM Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2007to Feb 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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".
- Conditions
- Sinusitis
- Being tested
- Saline solution, Sinuclean DM Spray
- Keywords
- Sinusitis
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline solutionBiological
Also called Libenar
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
Sinuclean DM SprayDevice
Also called Sinuclean DM Nasal Spray
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Saline solution |
| Sinuclean treatment | Experimental | Sinuclean DM Spray. Receives: Device: Sinuclean DM Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: After two weeks
Secondary outcomes (4)
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
Measured: After one week
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.
Measured: After two weeks
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.
Measured: After one week
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.
Measured: After two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galsor S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaetano Paludetti, MD, Principal investigator, University Cattolica del Sacro Cuore Roma Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747747
- Sponsor's protocol ID
- GAL-01-2007
- Other IDs
- EudraCT: 2007-003739-22
- Acronym
- SToSS
- Status last verified
- Mar 2012
- First submitted
- 4 Sep 2008
- Last updated
- 14 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00747747
- Acronym / sponsor ID
- SToSS / GAL-01-2007
- Conditions
- Sinusitis
- Keywords
- Sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Galsor S.r.l.Industry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 14 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Biological: Saline solutionSaline solution sprayed according to the product indication. Only one brand/specific product has been selected. |
| Sinuclean treatment | Experimental | Device: Sinuclean DM SpraySinuclean DM Spray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline solutionAlso: Libenar3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed | Biological | Saline solution |
| Sinuclean DM SprayAlso: Sinuclean DM Nasal Spray3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed | Device | Sinuclean treatment |
Primary outcome
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
Time frame: After one week
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
Mucus detection in paranasal sinuses by clinical assessment(Outcome Measure Percentage of patients)
4 secondary outcomes
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
Time frame: After one week
FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
Time frame: After two weeks
Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)
Time frame: After one week
Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)
Time frame: After two weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
RecruitingPhase 4
Comparative Effectiveness of Available Treatments for Sinus and Ear Infections in Children (Acute Sinusitis)
ACUTE SINUSITIS, Sinusitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Paludetti, MD principal investigator
University Cattolica del Sacro Cuore Roma Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline solution and Sinuclean DM Spray in people with Sinusitis, run by Galsor S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) (time frame: After one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.