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NCT Number: NCT07198607

Pistacia Lentiscus Oil Nasal Drops for Preventing Recurrence of Chronic Rhinosinusitis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ent Clinic ASST Settelaghi, University of Insubriae

Varese, Italy

About this study

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 tool in CRS management.

This monocenter, non-profit, retrospective observational case-control clinical study was conducted 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 retrospectively evaluated and compared between patients receiving 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) and patients receiving isotonic saline wash alone 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Winterized Pistacia lentiscus oil; Bactorinol®

Isotonic Saline Nasal Wash

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Ciliary motility

    Time frame: 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.

  2. Presence of Nasal Secretion

    Time frame: Baseline, 1 month, and 1 year

    Presence or absence of nasal secretion, assessed by anterior rhinoscopy.

  3. Characteristics of Nasal Secretion

    Time frame: Baseline, 1 month, and 1 year

    Nasal secretion characteristics (clear, mucopurulent, or purulent) will be graded by anterior rhinoscopy using standardized clinical evaluation.

  4. Presence of biofilm

    Time frame: Baseline, 1 month, and 1 year

    Cytological evaluation of mucosal samples stained for biofilm, identified by cyan-colored areas.

  5. Presence of supranuclear striae

    Time frame: Baseline, 1 month, and 1 year

    Microscopic evaluation of nasal mucosa samples for supranuclear striae.

  6. Presence of bacterial cells

    Time frame: Baseline, 1 month, and 1 year

    Cytological evaluation of mucosal samples for bacterial cells.

  7. Cellularity variation

    Time frame: Baseline, 1 month, and 1 year

    Quantitative cytology of neutrophils, eosinophils, and mast cells from nasal mucosa samples.

  8. Number of Participants With Treatment-Related Adverse Events

    Time frame: 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.

  9. Local Tolerability of Nasal Drops

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • Università degli Studi dell'Insubria

Registry information

Official study title

The Role of Pistacia Lentiscus Oil in the Prevention of Chronic Rhinosinusitis Recurrence During Long-Term Therapy: A Retrospective Observational Case-Control Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 30, 2025
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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