Sinusitis
Conditions
Keywords
Sinusitis
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 1. = mild symptom: clearly perceptible, but easily tolerated 2. = moderate symptom: clear awareness of the symptom, that is annoying but tolerable 3. = 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.
Interventions
BIOLOGICALSaline solution
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
DEVICESinuclean DM Spray
3 sprays per nostrils twice a day (morning and evening); in case of need a third nebulization between the two is allowed
Sponsors
Galsor S.r.l.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | After one week | Mucus detection in paranasal sinuses by clinical assessment(Outcome measure Percentage of patients) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | After one week | 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) | After one week | 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) | After two weeks | 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. |
Countries
Italy
Participant flow
Recruitment details
Period of recruitment: Nov 2007 - Mar 2009 Location: Outpatients attending medical visits by General Practitioners
Participants by arm
| Arm | Count |
|---|---|
| Control 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. | 14 |
| Saline Treated. Saline solution sprayed three times in each nostril, twice a day (morning - evening) | 14 |
| Sinuclean Treated. Sinuclean sprayed three times in each nostril, twice a day (morning - evening) | 21 |
| Total | 49 |
Baseline characteristics
| Characteristic | Saline Treated. | Sinuclean Treated. | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 21 Participants | 14 Participants | 49 Participants |
| Age Continuous | 45 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 13 | 45 years STANDARD_DEVIATION 15 | 47 years STANDARD_DEVIATION 13 |
| Region of Enrollment Italy | 14 participants | 21 participants | 14 participants | 49 participants |
| Sex: Female, Male Female | 5 Participants | 11 Participants | 8 Participants | 24 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 6 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 1 / 14 | 0 / 21 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 21 |
Outcome results
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)
Time frame: After two weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | 29 percentage of patients |
| Saline Treated. | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | 29 percentage of patients |
| Sinuclean Treated. | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | 15 percentage of patients |
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)
Time frame: After one week
Population: The patients were eligible according to inclusion and exclusion criteria and were compliant with the study requirements.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | 71 percentage of patients |
| Saline Treated. | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | 57 percentage of patients |
| Sinuclean Treated. | Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) | 33 percentage of patients |
Comparison: Null hypothesis: no difference among groups.p-value: <0.05Chi-squared
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
Time frame: After one week
Population: Eligibility per in/ex criteria and compliance with study requirements and diary completion requirements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | 57 percentage of patients |
| Saline Treated. | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | 43 percentage of patients |
| Sinuclean Treated. | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | 52 percentage of patients |
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.
Time frame: After two weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | 79 percentage of patients |
| Saline Treated. | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | 93 percentage of patients |
| Sinuclean Treated. | FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject | 81 percentage of patients |
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.
Time frame: After two weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) | 57 percentage of patients |
| Saline Treated. | Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) | 64 percentage of patients |
| Sinuclean Treated. | Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) | 90 percentage of patients |
Comparison: Null hypotheis: no difference among the groups.p-value: <0.05Chi-squared
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.
Time frame: After one week
Population: Eligibility according to in/ex criteria and compliance with study requirements
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) | 29 percentage of patients |
| Saline Treated. | Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) | 29 percentage of patients |
| Sinuclean Treated. | Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) | 52 percentage of patients |