Pistacia Lentiscus Oil Nasal Spray With Reduced-Dose Mometasone in Chronic Rhinosinusitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Mometasone furoate - intranasal application: Mometasone 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: Bactorinol® 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change in Sino-Nasal Outcome Test-22 (SNOT-22) Score — Baseline, 12 weeks, and 24 weeks
  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.

Trial sites (1)

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