Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

NCT07198607 | Completed DMC

• 1 other identifier: 116_22novembre2024_BACTORINOL
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Participants received 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®)

Saline Solution Control

Participants received isotonic saline nasal wash alone on the same administration schedule over the study period.

Other: Isotonic Saline Nasal Wash

Interventions

Pistacia lentiscus Oil Nasal Drops (Bactorinol®) OTHER

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.

Also known as: Winterized Pistacia lentiscus oil; Bactorinol®

Experimental: Pistacia lentiscus Oil Nasal Drops

Isotonic Saline Nasal Wash OTHER

Participants received isotonic saline nasal wash alone according to the same administration schedule used in the comparison group.

Saline Solution Control

Eligibility Criteria

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

Study Population

Adult patients aged ≥18 years with diagnosed chronic rhinosinusitis (CRS) who underwent long-term treatment with isotonic saline nasal wash plus Pistacia lentiscus oil nasal drops or isotonic saline nasal wash alone in a real-world clinical setting were retrospectively evaluated.

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: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Biochemistry and Experimental Medicine

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: April 4, 2023
• Primary Completion: March 3, 2025
• Study Completion: March 30, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)