Chronic Rhinosinusitis (Diagnosis), Chronic Rhinosinusitis Without Nasal Polyps
Conditions
Brief summary
This retrospective, observational, case-control clinical study evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis during long-term therapy. Adult patients with chronic rhinosinusitis who received isotonic saline wash plus Pistacia lentiscus oil drops were retrospectively compared with patients who received isotonic saline wash alone, with a total treatment duration of 12 months. The primary outcome was change in Sino-Nasal Outcome Test-22 (SNOT-22) scores, while secondary outcomes included ciliary motility, nasal secretion, biofilm presence, cytological changes, adverse events, and safety/tolerability.
Detailed description
Chronic rhinosinusitis (CRS) is a common and recurrent condition associated with significant morbidity and impaired quality of life. Standard treatment approaches often provide only partial or temporary relief, and recurrence rates remain high. Pistacia lentiscus oil has demonstrated anti-inflammatory and mucosal protective properties, supporting its potential role as a preventive tool in CRS management. This monocenter, non-profit, retrospective observational case-control clinical study was conducted to evaluate the long-term preventive effect of Pistacia lentiscus oil nasal drops on CRS recurrence. One hundred patients aged ≥18 years with diagnosed CRS were retrospectively evaluated and compared between patients receiving isotonic saline wash plus Pistacia lentiscus oil drops (5 drops per nostril twice daily for 30 days, followed by maintenance treatment for 15 days per month over 11 months) and patients receiving isotonic saline wash alone on the same schedule. The primary endpoint was the change in disease-specific quality of life, measured by the Sino-Nasal Outcome Test-22 (SNOT-22) from baseline to 12 months. Secondary endpoints included assessments of ciliary motility, nasal secretion, presence of biofilm, supranuclear striae, bacterial cells, variations in inflammatory cellularity (neutrophils, eosinophils, mast cells), safety, and tolerability.
Interventions
OTHERPistacia lentiscus Oil Nasal Drops (Bactorinol®)
Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants received isotonic saline nasal wash plus 5 drops per nostril twice daily for 30 days, followed by 5 drops per nostril twice daily for 15 days per month for the subsequent 11 months.
OTHERIsotonic Saline Nasal Wash
Participants received isotonic saline nasal wash alone according to the same administration schedule used in the comparison group.
Sponsors
Liaquat University of Medical & Health Sciences
Università degli Studi dell'Insubria
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Clinical diagnosis of chronic rhinosinusitis * Nasal polypoid score ≤1 * ≥4 episodes of recurrence per year * SNOT-22 score ≥10 Willingness and ability to provide written informed consent
Exclusion criteria
* Nasal polypoid score \>2 * \<4 episodes of recurrence per year * SNOT-22 score \<10 * Known immune disorders * Neoplastic disorders * Neurological disorders * Psychiatric disorders * Inability to undergo treatment * Refusal or inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sino-Nasal Outcome Test-22 (SNOT-22) score | Baseline, 1 month, and 1 year | The SNOT-22 questionnaire measures disease-specific quality of life in chronic rhinosinusitis patients. Scores range from 0 (no symptoms) to 110 (worst symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ciliary motility | Baseline, 1 month, and 1 year | Assessment of ciliary beat frequency and duration using phase contrast optical microscopy; considered normal if beating lasts \>10 minutes. |
| Presence of Nasal Secretion | Baseline, 1 month, and 1 year | Presence or absence of nasal secretion, assessed by anterior rhinoscopy. |
| Characteristics of Nasal Secretion | Baseline, 1 month, and 1 year | Nasal secretion characteristics (clear, mucopurulent, or purulent) will be graded by anterior rhinoscopy using standardized clinical evaluation. |
| Presence of biofilm | Baseline, 1 month, and 1 year | Cytological evaluation of mucosal samples stained for biofilm, identified by cyan-colored areas. |
| Presence of supranuclear striae | Baseline, 1 month, and 1 year | Microscopic evaluation of nasal mucosa samples for supranuclear striae. |
| Presence of bacterial cells | Baseline, 1 month, and 1 year | Cytological evaluation of mucosal samples for bacterial cells. |
| Cellularity variation | Baseline, 1 month, and 1 year | Quantitative cytology of neutrophils, eosinophils, and mast cells from nasal mucosa samples. |
| Number of Participants With Treatment-Related Adverse Events | Throughout study period (up to1 year) | Safety will be assessed by recording all adverse events (local and systemic) related to nasal drop use, as evaluated by the investigator. |
| Local Tolerability of Nasal Drops | Baseline, 1 month, and 1 year | Local tolerability will be assessed by anterior rhinoscopy for signs of nasal irritation (redness, swelling, mucosal damage) and patient-reported nasal discomfort using a Visual Analogue Scale (0-10). |
Countries
Italy
Outcome results
None listed