Adenoidal DisorderNCT06478433
Study on the Efficacy and Safety of a Device for Post-op Recovery in Pediatric Adenectomy/Adenotonsillectomy.
A study testing Munatoril Aerosol Combo and Iperclenny in people with Adenoidal Disorder and Tonsillitis, run by Pharmaluce srl.
Trial summary
The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy… Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Adenoidal Disorder, Tonsillitis, Otorhinolaryngologic Diseases
- What is being tested?
- Munatoril Aerosol Combo and Iperclenny
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients of either sex aged 2 to 17 years who are candidates for adenoidectomy or adenotonsillectomy surgery.
- Acquisition and signing of informed consent by the legal guardian.
Who cannot join
- Syndromic patients.
- Patients allergic to any substance in the study formulations.
- Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
- Active respiratory infection in the 2 weeks prior to study entry.
- Patients with a history of chronic epistaxis or immunodeficiency.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: "Efficacy and Safety Study of the Medical Device Munatoril® Aerosol Combo in the Recovery of Nasal Homeostasis in Pediatric Patients Undergoing Adenoidectomy or Adenotonsillectomy."
The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy, compared with a hypertonic solution and an over-the-counter isotonic solution (control group).
The primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution.
Read more
Endpoints Evaluation of subjective longitudinal differences (intragroup over-time change) and differences between study group and control group (intergroup difference) regarding the use of the medical device, obtained following the protocol, with assessment at 8, 15 and 30 days after surgery by Likert Scale Score for tolerability, and at 0, 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy.
In addition, there is a recording of any adverse events in both groups at 8, 15 and 30 days post-surgery, and an inter-group comparative evaluation.
Participants: Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited. Follow-up will last 30 days.
Read the detailed description
Sample selection criteria
Inclusion criteria.
Patients of either sex aged 2 to 17 years, candidates for adenoidectomy or adenotonsillectomy surgery.
Acquisition and signing of informed consent by the legal guardian. Exclusion criteria.
Syndromic patients. Patients allergic to any substance in the study formulations. Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
Active respiratory infection in the 2 weeks prior to study entry. Patients with a history of chronic epistaxis or immunodeficiency. 2.3 Study exit criteria.
For reasons related to study treatment (adverse event); for reasons related to surgery (adverse event); for non-treatment-related reasons (death due to illness, patient transfer to other treatment site); for patient-related reasons (withdrawal of consent, poor compliance); for reasons related to compliance with procedures/other (protocol violations, administrative problems); for withdrawal of consent by the patient's parents or legal guardians. In cases of exit from follow-up, there is provision for reporting the exit, including the date and reasons for it.
- Being tested
- Munatoril Aerosol Combo, Iperclenny
- Keywords
- nasal irrigation
- Medical subject headings
- Tonsillitis, Otorhinolaryngologic Diseases, Nose Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Munatoril Aerosol ComboDevice
Munatoril® Aerosol Combo is a Medical Device that contains:
5 ml single-dose vials of sterile, 3% hypertonic, near-neutral pH bromine-iodine saline solution, based on Cervia integral sea salt, salso-bromo-iodine saline mother water from the Cervia Thermal Baths and hyaluronic acid with high molecular weight.
Lavonase® syringe with blue nebulizer valve (microsol), 10 ml, Medical Device for the administration of solutions in nebulized form within the nasal cavities and nasopharynx.
IperclennyDevice
Also called Isoclenny
Hypertonic and Isotonic solution present on market in italy.
| Study group | Role | What they receive |
|---|---|---|
| Munatoril | Experimental | Experimental: Munatoril From day 1 to day 7 postoperatively: SID administration of Munatoril® Aerosol Combo by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe.
From day 8 to day 14 postoperatively:
SID administration of Munatoril® Aerosol Combo via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe.
- From postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution obtained by diluting Munatoril® Aerosol Combo hypertonic solution Receives: Device: Munatoril Aerosol Combo |
| Control | Active comparator | Active Comparator: Control Day 1 to day 7 postoperative: SID administration of Hypertonic Solution by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe.
Postoperative day 8 to day 14:
SID administration of hypertonic solution via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe.
- Postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution. Receives: Device: Iperclenny |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective evaluation for efficacy: QoL
The investigator will use the questionnaire "Sino-Nasal Outcome Test-22 (SNOT-22)" for the evaluation of QoL and the symptoms impact on patient's life. The SNOT-22 is based on a Likert scale where 0 = "No problem", 1 = "Very mild problem", 2 = "Mild or slight problem", 3 = "Moderate problem", 4 = "Severe problem", and 5 = "Problem as bad as it can be." Are 22 items and the score can be from 0 to 110. Higher scores means a worse outcome.
Measured: T0 (preoperative) - T2 (15 days) - T3 (30 days).
Secondary outcomes (1)
Objective evaluation for efficacy: Lund-kennedy Score
Lund-kennedy Score: This score assesses the severity of three objective data trough nasal endoscopy. It is polyps (0, none; 1, in the middle meatus; 2, beyond the middle meatus); discharge (0, none; 1, clear and thin; 2, thick and purulent); edema (0, absent; 1, mild; 2, severe); scarring/adhesions (0, absent; 1, mild; 2, severe); and crusting (0, absent; 1, mild; 2, severe). The score can be from 0 to 10. Higher scores means a worse outcome.
Measured: T0 (intraopertory ) - T2 (15 days) - T3 (30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoidal DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective prospective single-center controlled non-randomized for-profit interventional study.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmaluce srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gruppo FarmaImpresa
- Responsible party
- Sponsor
- Investigators
- Laura Tedeschi, Master, Study chair, Gruppo FarmaImpresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478433
- Sponsor's protocol ID
- Munatoril® Aerosol Combo_2024
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Efficacy and Safety Study of the Medical Device Munatoril® Aerosol Combo in the Recovery of Nasal Homeostasis in Pediatric Patients Undergoing Adenoidectomy or Adenotonsillectomy."
- ClinicalTrials.gov ID
- NCT06478433
- Acronym / sponsor ID
- Munatoril® Aerosol Combo_2024
- Keywords
- nasal irrigation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Pharmaluce srlIndustry (pharma, biotech, devices)
- Collaborators
- Gruppo FarmaImpresa
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 27 Jun 2024 (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.
The objective of this prospective pre-market interventional clinical study is to evaluate the efficacy and safety of the medical device Munatoril® Aerosol Combo in its different modalities of use, through the analysis of clinical and subjective outcomes in children operated on adenoidectomy or adenotonsillectomy, compared with a hypertonic solution and an over-the-counter isotonic solution (control group).
The primary question it aims to answer is whether the components prensent in Munatoril provide a benefit and whether they play a role in the recovery of nasal homeostasis following adeinodectomy and adenotonsillectomy compared with an over-the-counter hypertonic saline solution.
Endpoints Evaluation of subjective longitudinal differences (intragroup over-time change) and differences between study group and control group (intergroup difference) regarding the use of the medical device, obtained following the protocol, with assessment at 8, 15 and 30 days after surgery by Likert Scale Score for tolerability, and at 0, 15 and 30 days by SNOT22 Score and Lund-Kennedy Endoscopic Score for efficacy.
In addition, there is a recording of any adverse events in both groups at 8, 15 and 30 days post-surgery, and an inter-group comparative evaluation.
Participants: Pediatric patients who are candidates for adenoidectomy or adenotonsillectomy surgery at the study site facility will be systematically evaluated preoperatively for inclusion in the clinical trial and possibly recruited. Follow-up will last 30 days.
Detailed description
Sample selection criteria
Inclusion criteria.
Patients of either sex aged 2 to 17 years, candidates for adenoidectomy or adenotonsillectomy surgery.
Acquisition and signing of informed consent by the legal guardian. Exclusion criteria.
Syndromic patients. Patients allergic to any substance in the study formulations. Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
Active respiratory infection in the 2 weeks prior to study entry. Patients with a history of chronic epistaxis or immunodeficiency. 2.3 Study exit criteria.
For reasons related to study treatment (adverse event); for reasons related to surgery (adverse event); for non-treatment-related reasons (death due to illness, patient transfer to other treatment site); for patient-related reasons (withdrawal of consent, poor compliance); for reasons related to compliance with procedures/other (protocol violations, administrative problems); for withdrawal of consent by the patient's parents or legal guardians. In cases of exit from follow-up, there is provision for reporting the exit, including the date and reasons for it.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective prospective single-center controlled non-randomized for-profit interventional study.
| Arm | Type | Receives |
|---|---|---|
| Munatoril | Experimental | Device: Munatoril Aerosol ComboExperimental: Munatoril From day 1 to day 7 postoperatively: SID administration of Munatoril® Aerosol Combo by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe. From day 8 to day 14 postoperatively: SID administration of Munatoril® Aerosol Combo via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe. - From postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution obtained by diluting Munatoril® Aerosol Combo hypertonic solution |
| Control | Active comparator | Device: IperclennyActive Comparator: Control Day 1 to day 7 postoperative: SID administration of Hypertonic Solution by aerosol therapy, in the morning + TID administration of an over-the-counter sterile isotonic solution by Lavonase® syringe. Postoperative day 8 to day 14: SID administration of hypertonic solution via Lavonase® syringe, in the morning + TID administration of an over-the-counter sterile isotonic solution, via Lavonase® syringe. - Postoperative day 15 to day 29: TID administration via Lavonase® syringe of an isotonic solution. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients of either sex aged 2 to 17 years who are candidates for adenoidectomy or adenotonsillectomy surgery.
- Acquisition and signing of informed consent by the legal guardian.
Key exclusion criteria (5 listed)
- Syndromic patients.
- Patients allergic to any substance in the study formulations.
- Patients who have used intranasal corticosteroids, topical or systemic corticosteroids, or any intranasal medication in the week prior to study entry.
- Active respiratory infection in the 2 weeks prior to study entry.
- Patients with a history of chronic epistaxis or immunodeficiency.
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 |
|---|---|---|
| Munatoril Aerosol ComboMunatoril® Aerosol Combo is a Medical Device that contains: 5 ml single-dose vials of sterile, 3% hypertonic, near-neutral pH bromine-iodine saline solution, based on Cervia integral sea salt, salso-bromo-iodine saline mother water from the Cervia Thermal Baths and hyaluronic acid with high molecular weight. Lavonase® syringe with blue nebulizer valve (microsol), 10 ml, Medical Device for the administration of solutions in nebulized form within the nasal cavities and nasopharynx. | Device | Munatoril |
| IperclennyAlso: IsoclennyHypertonic and Isotonic solution present on market in italy. | Device | Control |
Primary outcome
Subjective evaluation for efficacy: QoL
Time frame: T0 (preoperative) - T2 (15 days) - T3 (30 days).
The investigator will use the questionnaire "Sino-Nasal Outcome Test-22 (SNOT-22)" for the evaluation of QoL and the symptoms impact on patient's life. The SNOT-22 is based on a Likert scale where 0 = "No problem", 1 = "Very mild problem", 2 = "Mild or slight problem", 3 = "Moderate problem", 4 = "Severe problem", and 5 = "Problem as bad as it can be." Are 22 items and the score can be from 0 to 110. Higher scores means a worse outcome.
1 secondary outcome
Objective evaluation for efficacy: Lund-kennedy Score
Time frame: T0 (intraopertory ) - T2 (15 days) - T3 (30 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Laura Tedeschi, Master study chair
Gruppo FarmaImpresa
Questions about this trial
What is this clinical trial studying?
A study testing Munatoril Aerosol Combo and Iperclenny in people with Adenoidal Disorder and Tonsillitis, run by Pharmaluce srl.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nader Nassif, Doctor (0303996226, nader.nassif@asst-spedalicivili.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective evaluation for efficacy: QoL (time frame: T0 (preoperative) - T2 (15 days) - T3 (30 days).). 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 3 Jul 2024.