Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses. Medical treatment is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance, including intranasal corticosteroids and nasal saline irrigations.
This interventional, prospective, single-arm, single-sequence, two-period study aims to evaluate the maintenance of clinical control of chronic rhinosinusitis during dose reduction of mometasone and introduction of Bactorinol® nasal spray, in order to evaluate the possible compensatory role of the medical device compared with the full dose of mometasone.
Participants will receive mometasone furoate nasal spray 2 puffs daily during the first 12 weeks, followed by 12 weeks of mometasone furoate nasal spray 1 puff daily combined with Bactorinol® nasal spray 3 puffs per nostril twice daily. Clinical outcomes will be compared between the two treatment periods.
Age ≥18 years.
Diagnosis of chronic rhinosinusitis with nasal polyposis (CRSwNP) or without nasal polyposis (CRSsNP).
Clinical indication for treatment with an intranasal corticosteroid (mometasone furoate).
Ability to understand and sign informed consent.
Neoplastic pathologies of all degrees.
Neurological or psychiatric disorders that may impair adherence to treatment and/or understanding of the informed consent form.
Pregnancy or lactation.
Chronic drug and/or alcohol use.
Single group
Mometasone furoate - intranasal application
DrugMometasone furoate nasal spray administered at 2 puffs daily during the first 12-week treatment period. During the subsequent 12-week treatment period, the dose is reduced to 1 puff daily and administered in combination with Bactorinol® nasal spray.
Bactorinol nasal spray
DeviceBactorinol® nasal spray is a medical device containing a patented formula of winterized Pistacia lentiscus oil. During the second 12-week treatment period, participants use Bactorinol® nasal spray at a dose of 3 puffs per nostril twice daily, in combination with mometasone furoate nasal spray 1 puff daily.
Change in Sino-Nasal Outcome Test-22 (SNOT-22) Score
The Sino-Nasal Outcome Test-22 (SNOT-22) consists of 22 items scored from 0 (no problem) to 5 (problem as bad as it can be), with a total score ranging from 0 to 110. Higher scores indicate a greater impact of symptoms on quality of life. SNOT-22 is assessed at enrollment (T0), after 12 weeks of full-dose mometasone (T12), and after 12 additional weeks of reduced-dose mometasone plus Bactorinol® (T24). The primary analysis is the intra-subject change in SNOT-22 score from T12 to T24.
Change in Nasal Congestion Severity (CQ7)
Nasal congestion severity will be assessed using the Congestion Quantifier Seven-Item Test (CQ7). The questionnaire consists of 7 items, each scored from 0 (never) to 4 (always), with a total score ranging from 0 to 28. Higher scores indicate greater severity of nasal congestion. CQ7 will be assessed at enrollment (T0), after 12 weeks (T12), and after 24 weeks (T24).
Change in Rhinorrhea Intensity (VAS)
Rhinorrhea intensity will be assessed using a visual analogue scale (VAS) ranging from 0 to 10, where 0 indicates no rhinorrhea and 10 indicates the worst possible rhinorrhea. VAS scores will be assessed at enrollment (T0), after 12 weeks (T12), and after 24 weeks (T24).
Use of Antibiotic Therapy
Use of antibiotic therapy during the study will be assessed and compared between the study periods.
Adverse Events
Adverse events occurring during the study will be recorded and assessed.
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Liaquat University of Medical & Health Sciences
Lead sponsor
University of Urbino "Carlo Bo"
Collaborator
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