SODIUM SULFIDE NONAHYDRATE, SACCHAROMYCES CEREVISIAE TYPE D EXTRACT for Acute rhinitis | Rhinopharyngitis | Rhinosinusitis

Inclusion criteria

• {"criterion_text":"- Patients who (or in case of 6-18 years old whose legal representative) have signed the Informed Consent.\n- Age: children 6-18 years old and adults 18- 70 years old.\n- Sex: male & female subjects.\n- Indication: Patients with clinical diagnosis of acute rhinitis, rhinopharyngitis, rhinosinusitis with sudden onset of minimum two relevant symptoms for ≤ 48 hours prior to enrollment, which are nasal blockage/ obstruction/ congestion rhinorrhea (nasal discharge - anterior/ posterior nasal drip)\n- Patient having the cognitive and functional abilities for answering the symptom specific questions.\n- Patients willing to use acceptable birth control methods during the course of the study, that result in a failure rate of more than 1% per year including: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, cap, diaphragm or sponge with spermicide. In case of menstruating adolescents up to 16 years of age, sexual abstinence is acceptable.\n- Patient willing and able to understand the study information and comply with all the study activities and procedures."}

Exclusion criteria

• {"criterion_text":"- Body temperature greater than 38°C measured on the forehead or neck with a non-contact infrared thermometer at enrolment.\n- Sinus or any other nasal post-surgery care.\n- Any contraindications for application of Actisoufre solution for nasal spray.\n- Any clinically relevant structural nasal abnormalities, i.e., nasal septal perforation, nasal polyps, other nasal malformations (detected in anterior rhinoscopy), or history of frequent nosebleeds.\n- Any congenital or chronic disease that in the opinion of the Investigator would adversely affect the results of the study (e.g., asthma, chronic bronchitis, chronic rhinosinusitis, etc.).\n- Any kind of immunodeficiency.\n- Hypersensitivity or allergy or intolerance to any component of the ingredients of the trial intervention.\n- Positive medical history to any significant infection within the 2 weeks prior to the enrolment.\n- Known current pregnancy or breast-feeding.\n- Subjects currently participating or having participated in another clinical trial during the last 30 days prior to enrolment (Day 0).\n- Any secondary infection (such as bronchitis, otitis, tracheitis, pneumonia, and so on) at enrolment.\n- Acute tonsillitis at the day of enrolment.\n- Use of saline nose drops or nasal sprays or pumps other than the study products, systemic antibiotics, antivirals, intranasal medicines, decongestants, antihistamines, echinacea, combination cold formulas, supplements containing > 10 mg zinc that would influence symptoms scores at enrolment or within 12 hours prior the day of screening.\n- Prior upper respiratory tract infection within 2 weeks prior to enrollment.\n- Chronic allergic or non-allergic rhinitis with symptoms such as chronic nasal obstruction, sneezing, watery rhinorrhea, nasal itching, and itchy watery eyes at the day of enrollment.\n- Use of antibiotics, systemic antiviral medications, corticosteroids (local and systemic), pseudoephedrine, phenylephrine, or anti-allergic treatment (only topical use of corticosteroids for dermatology reasons is allowed) within past 7 days.\n- Use of anti-snoring sprays into the nose and/or pharynx.\n- Previous sinus surgery within 6 months prior to enrolment."}

Primary endpoints

• {"endpoint_text":"- Change of the nasal symptoms (nasal obstruction, rhinorrhea (drip, sniff, snorting, drainage, discharge), thick mucus, sneezing, cough evaluated from baseline at Day 4 based on the specific “Common Cold Symptoms Severity Questionnaire” (CCSS), in the intervention group and in the control group. [Time points of CCSS assessment: Baseline (Day 1), Day 2, Day 3, Day 4, Day 8]","definition_or_measurement_approach":"Measured by the Common Cold Symptoms Severity Questionnaire (CCSS) assessing nasal symptoms from baseline to Day 4 with assessments at Baseline (Day 1), Day 2, Day 3, Day 4 and Day 8."}

Secondary endpoints

• {"endpoint_text":"- Change in the quality of sleep in the Actisoufre arm comparing to the placebo. [Time point: Baseline (Day 1), Day 2, Day 3, Day 4, Day 8]","definition_or_measurement_approach":"Change in quality of sleep assessed at Baseline (Day 1), Day 2, Day 3, Day 4 and Day 8 (method/instrument not further specified in provided data)."}
• {"endpoint_text":"- Change in patient’s Quality of Life based on the VAS scale [Time point: Baseline (Day 1), Day 4, Day 8]","definition_or_measurement_approach":"Patient-reported Quality of Life measured using a VAS scale at Baseline (Day 1), Day 4 and Day 8."}
• {"endpoint_text":"- Evaluation of onset of immediate relief after the entire product application is completed at Day 1 (baseline) and once daily up to Day 4 of the study. [Time point: Baseline, Day 2, Day 3, Day 4]","definition_or_measurement_approach":"Assessment of immediate relief onset after product application at Baseline and daily through Day 4 (specific measurement instrument not detailed)."}
• {"endpoint_text":"- Number of subjects with a need of use of nasal decongestants as an emergency treatment. [Time point: Day 8]","definition_or_measurement_approach":"Counting subjects requiring nasal decongestants as rescue/emergency treatment assessed at Day 8."}
• {"endpoint_text":"- Assessment of use of concomitant medications (including frequency) from baseline to the end of the study. [Time point: Baseline, Day 4, Day 8]","definition_or_measurement_approach":"Recording use and frequency of concomitant medications from Baseline through Day 4 and Day 8."}
• {"endpoint_text":"- Number of Adverse Events and Serious Adverse Events in intervention group comparing to the control group. [Time point: Baseline, Day 4, Day 8]","definition_or_measurement_approach":"Counting and comparing adverse events and serious adverse events between intervention and control groups at Baseline, Day 4 and Day 8."}

Poland

Earliest CTIS Part Ii Submission Date

04-08-2025

Latest Decision Or Authorization Date

08-09-2025

Processing Time Days

35

Number Of Sites

13

Number Of Participants

248

Primary sponsor

Full Name

Laboratoires Grimberg

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Third parties

• {"country":"Poland","full_name":"Clinmark Sp. z o.o.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,14,2,3,5,6,7,8","organisation_type":"Pharmaceutical company"}