An interventional study of Mometasone furoate - intranasal application and Bactorinol nasal spray in Chronic Rhinosinusitis (CRS), sponsored by Liaquat University of Medical & Health Sciences. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Liaquat University of Medical & Health Sciences · Not applicable, Interventional, and Treatment
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.
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.
251 studies on the registry are indexed under Rhinosinusitis; 69 are open to participants now.
This study's planned enrollment of 64 is below the median of 74 across 177 interventional studies indexed under Rhinosinusitis.
Browse Rhinosinusitis studies →Liaquat University of Medical & Health Sciences is the lead sponsor of 55 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Mometasone furoate - intranasal application · Device: Bactorinol nasal spray
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 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.
Also known as: Bactorinol® (manufacturer: PharmExtracta S.p.A.)
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.
Time frame: Baseline, 12 weeks, and 24 weeks
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).
Time frame: Baseline, 12 weeks, and 24 weeks
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).
Time frame: Baseline, 12 weeks, and 24 weeks
Use of Antibiotic Therapy
Use of antibiotic therapy during the study will be assessed and compared between the study periods.
Time frame: 24 weeks
Adverse Events
Adverse events occurring during the study will be recorded and assessed.
Time frame: 24 weeks
Treatment Adherence
Treatment adherence will be assessed based on compliance with the prescribed study intervention during the 24-week study period.
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jul 2027, 10 months later.
Of 33 interventional studies with no phase under Rhinosinusitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Liaquat University of Medical & Health Sciences