Chronic Rhinosinusitis (CRS)
Conditions
Brief 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.
Detailed description
Chronic rhinosinusitis (CRS) is a persistent inflammatory disease of the nose and sinuses, characterized by symptoms lasting for at least 12 weeks. CRS may occur with or without nasal polyposis and can have a significant impact on quality of life, including nasal breathing, sleep, daily activities, work performance, and general well-being. Medical treatment of CRS is mainly based on topical therapies aimed at controlling mucosal inflammation and improving naso-sinus clearance. Intranasal corticosteroids and nasal saline irrigations are recommended for symptom relief. However, despite these treatments, some patients continue to experience persistent or recurrent symptoms and may require additional therapies and/or antibiotic courses. Bactorinol® nasal spray (manufacturer: PharmExtracta S.p.A.) is a medical device based on winterized Pistacia lentiscus oil and is indicated as a support in cases of nasal congestion, promoting the fluidification of secretions and soothing irritated nasal mucosa. Pistacia lentiscus derivatives have been described as having potential antimicrobial, antioxidant, and anti-inflammatory properties, providing a rationale for evaluating Bactorinol® nasal spray as a topical adjuvant in patients with CRS. This is an interventional, prospective, single-arm, single-sequence clinical trial with a two-period design and intra-subject comparison. The study aims to evaluate the maintenance of clinical control of chronic rhinosinusitis during dose reduction of mometasone and introduction of Bactorinol® nasal spray. The design allows evaluation of the non-inferiority in clinical efficacy of Bactorinol® nasal spray combined with half a dose of mometasone furoate, compared with results obtained in the same participants during the preceding period with full-dose mometasone furoate. The total treatment duration for each participant is 24 weeks. During the first 12 weeks, participants will receive mometasone furoate nasal spray 2 puffs daily. During the subsequent 12 weeks, participants will receive mometasone furoate nasal spray 1 puff daily combined with Bactorinol® nasal spray 3 puffs per nostril twice daily. Clinical assessments will be performed at enrollment (T0), after 12 weeks (T12), and after 24 weeks (T24). The impact of chronic rhinosinusitis symptoms on quality of life will be assessed using the Sino-Nasal Outcome Test-22 (SNOT-22). Nasal congestion will be assessed using the Congestion Quantifier Seven-Item Test (CQ7), and rhinorrhea intensity will be assessed using a 0-10 visual analogue scale (VAS). Antibiotic use will be recorded during the two study periods. Adverse events will be monitored throughout the study, and adherence and tolerability will be assessed during the Bactorinol® treatment period.
Interventions
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.
DEVICEBactorinol 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.
Sponsors
Liaquat University of Medical & Health Sciences
University of Urbino "Carlo Bo"
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-arm, single-sequence, two-period study with intra-subject comparison. All participants receive mometasone furoate nasal spray 2 puffs daily for 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Willingness to comply with the study protocol and follow-up visits.
Exclusion criteria
* 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. * Immunosuppression, including primary immunodepression, oncological pathology undergoing active chemotherapy/immunotherapy, or autoimmune pathology undergoing immunosuppressive treatment. * Known or suspected allergy to one or more excipients/components of the preparation under study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nasal Congestion Severity (CQ7) | Baseline, 12 weeks, and 24 weeks | 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) | Baseline, 12 weeks, and 24 weeks | 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 | 24 weeks | Use of antibiotic therapy during the study will be assessed and compared between the study periods. |
| Adverse Events | 24 weeks | Adverse events occurring during the study will be recorded and assessed. |
| Treatment Adherence | 24 weeks | Treatment adherence will be assessed based on compliance with the prescribed study intervention during the 24-week study period. |
Countries
Italy
Contacts
CONTACTProf. Davide Sisti, PhD
Outcome results
None listed