Chronic RhinosinusitisNCT07800273
Bactorinol® Nasal Spray With Reduced-Dose Mometasone in Adults With Chronic Rhinosinusitis
A study testing Bactorinol® (manufacturer: PharmExtracta S.p.A.) and Mometasone Furoate Nasal Spray in people with Chronic Rhinosinusitis, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Bactorinol® (manufacturer: PharmExtracta S.p.A.) and Mometasone Furoate Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 14 Sep 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Armonia Centro Polispecialistico
Porto Mantovano, Lombardy, 46047
Giuseppe Puma, MD, giuseppe.puma@asuitn.it
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Bactorinol® (manufacturer: PharmExtracta S.p.A.), Mometasone Furoate Nasal Spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bactorinol® (manufacturer: PharmExtracta S.p.A.)Device
Also called Bactorinol® Nasal Spray
Bactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks.
Mometasone Furoate Nasal SprayDrug
Mometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily.
| Study group | Role | What they receive |
|---|---|---|
| Treated Group | Experimental | Mometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril 2 times daily for 12 weeks. Receives: Device: Bactorinol® (manufacturer: PharmExtracta S.p.A.); Drug: Mometasone Furoate Nasal Spray |
| Control Group | Active comparator | Mometasone furoate nasal spray 2 puffs daily for 12 weeks. Receives: Drug: Mometasone Furoate Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22)
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.
Measured: Baseline to Week 12
Secondary outcomes (5)
Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)
Change in nasal congestion severity will be assessed using the Congestion Quantifier 7-item test (CQ7) in both study groups.
Measured: Baseline to Week 12
Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)
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.
Measured: Baseline to Week 12
Antibiotic Use During the Study
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.
Measured: Baseline to Week 12
Incidence of Adverse Events During Treatment
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.
Measured: Baseline to Week 12
Severity of Adverse Events Assessed by CTCAE
The intensity of adverse events due to treatment will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liaquat University of Medical & Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Responsible party
- Principal investigator, Dr. Amjad Khan, Liaquat University of Medical & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800273
- Sponsor's protocol ID
- 178_9giugno2026_BACTORINOL(2)
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07800273
- Acronym / sponsor ID
- 178_9giugno2026_BACTORINOL(2)
- Conditions
- Chronic Rhinosinusitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Liaquat University of Medical & Health SciencesUniversity, hospital or other
- Collaborators
- University of Urbino "Carlo Bo"
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated Group | Experimental | Device: Bactorinol® (manufacturer: PharmExtracta S.p.A.), Drug: Mometasone Furoate Nasal SprayMometasone furoate nasal spray 1 puff daily plus Bactorinol® nasal spray 3 puffs per nostril 2 times daily for 12 weeks. |
| Control Group | Active comparator | Drug: Mometasone Furoate Nasal SprayMometasone furoate nasal spray 2 puffs daily for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bactorinol® (manufacturer: PharmExtracta S.p.A.)Also: Bactorinol® Nasal SprayBactorinol® nasal spray, 3 puffs per nostril twice daily for 12 weeks. | Device | Treated Group |
| Mometasone Furoate Nasal SprayMometasone furoate nasal spray administered for 12 weeks. The Treated Group receives 1 puff daily and the Control Group receives 2 puffs daily. | Drug | Control Group, Treated Group |
Primary outcome
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.
5 secondary outcomes
Change in Nasal Congestion Severity Assessed by the Congestion Quantifier 7-Item Test (CQ7)
Time frame: Baseline to Week 12
Change in Rhinorrhea Intensity Assessed by Visual Analog Scale (VAS)
Time frame: Baseline to Week 12
Antibiotic Use During the Study
Time frame: Baseline to Week 12
Incidence of Adverse Events During Treatment
Time frame: Baseline to Week 12
Severity of Adverse Events Assessed by CTCAE
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
Related trials for Chronic Rhinosinusitis
RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bactorinol® (manufacturer: PharmExtracta S.p.A.) and Mometasone Furoate Nasal Spray in people with Chronic Rhinosinusitis, run by Liaquat University of Medical & Health Sciences at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Davide Sisti, PhD (+39 0722 304637, davide.sisti@uniurb.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life Assessed by the Sino-Nasal Outcome Test-22 (SNOT-22) (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.