Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

NCT ID: NCT07198607

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2025-08-30

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).

Conditions

Chronic Rhinosinusitis Without Nasal Polyps; Chronic Rhinosinusitis (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental: Pistacia lentiscus Oil Nasal Drops

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.

Group Type: EXPERIMENTAL

Pistacia lentiscus Oil Nasal Drops (Bactorinol®)

Intervention Type: OTHER

Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants will receive 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.

Placebo Comparator: Placebo Nasal Drops

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.

Group Type: PLACEBO_COMPARATOR

Placebo Nasal Drops (matched to Bactorinol®)

Intervention Type: OTHER

Placebo nasal drops identical in appearance and administration to Bactorinol®. Participants will receive isotonic saline nasal wash plus placebo drops, 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.

Interventions

Pistacia lentiscus Oil Nasal Drops (Bactorinol®)

Bactorinol® nasal drops (medical device containing ultra-fractioned and winterized Pistacia lentiscus oil). Participants will receive 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.

Intervention Type: OTHER

Placebo Nasal Drops (matched to Bactorinol®)

Placebo nasal drops identical in appearance and administration to Bactorinol®. Participants will receive isotonic saline nasal wash plus placebo drops, 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.

Intervention Type: OTHER

Other Intervention Names

Winterized Pistacia lentiscus oil; Bactorinol®; Saline-based placebo drops

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: collaborator

Liaquat University of Medical & Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Amjad Khan

Professor of Clinical Biochemistry and Experimental Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ent Clinic ASST Settelaghi, University of Insubriae

Varese, , Italy

Countries

Italy

Other Identifiers

IAR20221123

Identifier Type: -

Identifier Source: org_study_id