Phase 4
N=49
Sinuclean's Treatment Of Sinusitis' Symptoms
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00747747 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) — 71; 57; 33 percentage of patients — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Saline solution (Biological); Sinuclean DM Spray (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galsor S.r.l.
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) |
29; 29; 15 | — |
| PRIMARY Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients) |
29; 29; 15 | — |
| SECONDARY FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject |
79; 93; 81 | — |
| SECONDARY FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject |
79; 93; 81 | — |
| SECONDARY Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients) |
29; 29; 52 | — |
| SECONDARY Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients) |
57; 64; 90 | <0.05 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00747747). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.