Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

Liaquat University of Medical & Health Sciences

Status: Completed

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

Treatments: Other: Placebo Nasal Drops (matched to Bactorinol®); Other: Pistacia lentiscus Oil Nasal Drops (Bactorinol®)

Study type: Interventional

Funder types: Other

Identifiers

NCT07198607

IAR20221123

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental: Pistacia lentiscus Oil Nasal Drops

Experimental group

Description:

Participants will receive isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops. Dosage: 5 drops per nostril twice daily for 30 days, followed by maintenance therapy of 5 drops per nostril twice daily for 15 days each month over the subsequent 11 months.

Treatment:

Other: Pistacia lentiscus Oil Nasal Drops (Bactorinol®)

Placebo Comparator: Placebo Nasal Drops

Placebo Comparator group

Description:

Participants will receive isotonic saline nasal wash plus placebo nasal drops, matched in appearance and administration schedule. Dosage: 5 drops per nostril twice daily for 30 days, followed by maintenance therapy of 5 drops per nostril twice daily for 15 days each month over the subsequent 11 months.

Treatment:

Other: Placebo Nasal Drops (matched to Bactorinol®)