Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

NCT07198607 | Completed DMC

• 1 other identifier: IAR20221123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis Without Nasal Polyps; Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• Change in Sino-Nasal Outcome Test-22 (SNOT-22) score

  The SNOT-22 questionnaire measures disease-specific quality of life in chronic rhinosinusitis patients. Scores range from 0 (no symptoms) to 110 (worst symptoms).

  Baseline, 1 month, and 1 year

Secondary Outcomes (9)

• Ciliary motility

  Baseline, 1 month, and 1 year

• Presence of Nasal Secretion

  Baseline, 1 month, and 1 year

• Characteristics of Nasal Secretion

  Baseline, 1 month, and 1 year

• Presence of biofilm

  Baseline, 1 month, and 1 year

• Presence of supranuclear striae

  Baseline, 1 month, and 1 year

Study Arms (2)

Experimental: Pistacia lentiscus Oil Nasal Drops

EXPERIMENTAL

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.

Other: Pistacia lentiscus Oil Nasal Drops (Bactorinol®)

Placebo Comparator: Placebo Nasal Drops

PLACEBO COMPARATOR

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.

Other: Placebo Nasal Drops (matched to Bactorinol®)

Interventions

Placebo Nasal Drops (matched to Bactorinol®) 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.

Also known as: Saline-based placebo drops

Placebo Comparator: Placebo Nasal Drops

Pistacia lentiscus Oil Nasal Drops (Bactorinol®) 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.

Also known as: Winterized Pistacia lentiscus oil; Bactorinol®

Experimental: Pistacia lentiscus Oil Nasal Drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat University of Medical & Health Sciences: lead
• Università degli Studi dell'Insubria: collaborator

Study Sites (1)

Ent Clinic ASST Settelaghi, University of Insubriae

Varese, Italy

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind trial in which participants, care providers, investigators, and outcome assessors were unaware of group allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Model Details: Participants were randomized in a 1:1 ratio to receive either isotonic saline wash plus Pistacia lentiscus oil nasal drops or isotonic saline wash plus placebo drops.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: March 4, 2024
• Primary Completion: June 18, 2025
• Study Completion: August 30, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)