In short
Clinical trials of SODIUM SULFIDE NONAHYDRATE are studying a nasal spray in people with acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not need antibiotics. The main goal is to see whether it works better than placebo and to measure symptom improvement and safety in adults and children over 6 years old.
Key points
- SODIUM SULFIDE NONAHYDRATE is being studied in a Phase 3 clinical trial for people with acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not need antibiotics. The trial includes adults and children over 6 years old, and it compares a nasal spray with placebo. It is randomized, double blind, and multicentre, which means it is run at more than one site and treatment assignment is by chance. The main goal is to see whether the spray improves nasal symptoms such as blockage, runny nose, thick mucus, sneezing, and cough. The study plans to enroll 248 participants.
Trial overview
The trial with ID 2024-516284-90-00 is a Phase 3 study of SODIUM SULFIDE NONAHYDRATE, given as a nasal spray in a pressurized container, compared with placebo. It is designed to test whether the study spray helps people with acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not require antibiotic therapy.
The brief summary says the main purpose is to evaluate the effectiveness of Actisoufre nasal spray in adults and children over 6 years old. The study is interventional, which means participants receive a study treatment rather than only being observed.
Who can join the study
This study includes female and male adult and paediatric participants over 6 years of age. “Paediatric” means children and adolescents.
People must have acute rhinitis, rhinopharyngitis, or rhinosinusitis, and their illness must not need antibiotic therapy. In simple terms, the study is for common short-term nose and throat infections or inflammation where antibiotics are not considered necessary.
Study design and phase
This is a prospective, controlled, randomized, double blind, two-arm, parallel-group, multicentre study. “Prospective” means the study follows people forward in time after they join. “Randomized” means treatment is assigned by chance, and “double blind” means neither the participants nor the study team knows who receives the study spray or placebo.
“Two-arm” means there are two groups in the study, and “parallel-group” means the groups are followed at the same time. “Multicentre” means the study is run at more than one site.
The phase is Phase 3, which is usually used to confirm how well a treatment works in a larger group of patients and to continue safety monitoring.
What is being measured
The main outcome is the change in nasal symptoms from baseline to Day 4, measured with the Common Cold Symptoms Severity Questionnaire. Baseline means the starting point before treatment effects are measured.
The symptoms being tracked are nasal obstruction, rhinorrhea, thick mucus, sneezing, and cough. Rhinorrhea means a runny nose or drainage from the nose.
The questionnaire is used at Baseline, Day 2, Day 3, Day 4, and Day 8, so researchers can see how symptoms change over time.
Trial status and size
The trial status is Authorised. The planned enrollment is 248 participants.
The study compares the Actisoufre nasal spray with placebo, which helps researchers judge whether any symptom improvement is linked to the study treatment rather than chance alone.
What the study means for patients
For patients, this trial is looking at a short course of nasal spray treatment for common nose and throat inflammation that does not need antibiotics. The study focuses on practical symptoms that matter in daily life, such as blocked nose, runny nose, mucus, sneezing, and cough.
Because the trial is randomized and double blind, the results are intended to be fair and less biased. The main question is whether SODIUM SULFIDE NONAHYDRATE can improve symptoms better than placebo in this patient group.