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NCT Number: NCT07800273

Bactorinol® Nasal Spray With Reduced-Dose Mometasone in Adults With Chronic Rhinosinusitis

Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses, defined by the presence of symptoms for at least 12 weeks. Medical treatment of CRS is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance. However, despite these treatments, some patients continue to experience persistent or recurrent symptoms.

This prospective, single-center, randomized, controlled, non-profit study aims to evaluate the clinical efficacy of Bactorinol® nasal spray in patients with chronic rhinosinusitis, in order to reduce the impact of CRS symptoms on patients' quality of life in a non-inferior manner compared with treatment with the full dose of mometasone furoate nasal spray.

Participants will be randomly assigned in a 1:1 ratio to receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily, or mometasone furoate nasal spray 2 puffs daily. The treatment period will last 12 weeks.

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Key information

Conditions

Chronic Rhinosinusitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Armonia Centro Polispecialistico

Porto Mantovano, Lombardy, 46047, Italy

Location contact

Giuseppe Puma, MD

CONTACT

[email protected]

About this study

Bactorinol® nasal spray is a medical device based on winterized Pistacia lentiscus oil, indicated as a support in cases of nasal congestion, to promote the fluidification of secretions and soothe irritated nasal mucosa. Pistacia lentiscus derivatives have been described as having potential antimicrobial, antioxidant, and anti-inflammatory properties.

The study will evaluate whether the use of Bactorinol® nasal spray, included in a topical therapeutic strategy with intranasal corticosteroid, can improve quality of life and symptoms in patients with chronic rhinosinusitis. The study population includes patients diagnosed with chronic rhinosinusitis with nasal polyposis and without nasal polyposis.

This is a prospective, single-center, randomized, controlled study with a 1:1 allocation ratio. Participants will undergo a continuous 12-week treatment period. The treated group will receive mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril twice daily. The control group will receive mometasone furoate nasal spray 2 puffs daily.

Participants will be monitored throughout the study for safety, adherence, and clinical outcomes. Clinical evaluations and monitoring of adverse events will be performed at the beginning of the study and after 12 weeks of treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • Patients diagnosed with chronic rhinosinusitis with nasal polyposis (CRSwNP) and without polyposis (CRSsNP)
  • Clinical indication for treatment with intranasal corticosteroid (mometasone furoate)
  • Ability to understand and sign informed consent
  • Willingness to comply with the study protocol and follow-up visits (T0, T12 weeks)

Exclusion criteria

  • Neoplastic pathologies of all degrees
  • Neurological or psychiatric disorders such as to impair adherence to treatment and/or understanding of informed consent forms
  • Pregnancy and lactation
  • Chronic drug and/or alcohol use
  • Immunosuppressed subjects (primary immunodepression, oncological pathology undergoing active chemo/immunotherapy treatment, autoimmune pathology undergoing immunosuppressive treatment)
  • Allergy, even suspected, to one or more of the excipients of the preparation under study

Treatment and study plan

Bactorinol® (manufacturer: PharmExtracta S.p.A.)

Device

Bactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.

Other names: Bactorinol® Nasal Spray

Mometasone Furoate Nasal spray

Drug

Mometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily.

Primary outcomes

  1. Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)

    Time frame: Baseline to Week 12

    Change in the impact of chronic rhinosinusitis symptoms on patients' quality of life will be assessed using the validated Sino-Nasal Outcome Test-22 (SNOT-22) scale in both study groups.

Secondary outcomes

  1. Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)

    Time frame: Baseline to Week 12

    Change in nasal congestion severity will be assessed using the Congestion Quantifier 7-item test (CQ7) in both study groups.

  2. Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)

    Time frame: Baseline to Week 12

    Change in rhinorrhea intensity will be assessed using a Visual Analog Scale (VAS) from 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptom.

  3. Antibiotic Use During the Study

    Time frame: Baseline to Week 12

    Antibiotic use will be assessed by recording the number of doses used and the total number of days of antibiotic use during the study period.

  4. Incidence of Adverse Events During Treatment

    Time frame: Baseline to Week 12

    The incidence of adverse events due to treatment will be assessed through recording of adverse events in the data collection form throughout the study period.

  5. Severity of Adverse Events Assessed by CTCAE

    Time frame: Baseline to Week 12

    The intensity of adverse events due to treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE).

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Davide Sisti, PhD

CONTACT

[email protected]

+39 0722 304637

Sponsors and collaborators

Lead sponsor

Liaquat University of Medical & Health Sciences

Other

Collaborators

  • University of Urbino "Carlo Bo"

Registry information

Official study title

Effect of a Corticosteroid-Sparing Regimen Including Pistacia Lentiscus Oil Nasal Spray on Quality of Life in Patients With Chronic Rhinosinusitis: A Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 2, 2026
Registry last updated
Sep 2, 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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