Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis Without Nasal Polyps; Chronic Rhinosinusitis (Diagnosis)

• Registration Number: NCT07198607
• Lead Sponsor: Liaquat University of Medical & Health Sciences

Brief Summary

This randomized, double-blind, placebo-controlled clinical trial evaluated the safety and efficacy of nasal drops containing Pistacia lentiscus oil in preventing recurrence of chronic rhinosinusitis. Adult patients with chronic rhinosinusitis were randomized 1:1 to receive either isotonic saline wash plus Pistacia lentiscus oil drops or isotonic saline wash plus placebo, for 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 intervention in CRS management.

This monocenter, non-profit, randomized, placebo-controlled trial was designed 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 randomized in a 1:1 ratio to either the intervention group (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) or the placebo group (isotonic saline wash plus placebo drops 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. The study received ethical approval from the Italian Academy of Rhinology (Ref: IAR20221123).

Study Timeline

• Study Start: 2023-01-09
• Primary Completion: 2025-06-18
• Study Completion: 2025-08-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Ent Clinic ASST Settelaghi, University of Insubriae; 🇮🇹 Varese, Italy