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SODIUM SULFIDE NONAHYDRATE

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.

Table of contents

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.[1] It is designed to test whether the study spray helps people with acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not require antibiotic therapy.[1]

The brief summary says the main purpose is to evaluate the effectiveness of Actisoufre nasal spray in adults and children over 6 years old.[1] The study is interventional, which means participants receive a study treatment rather than only being observed.[1]

Who can join the study

This study includes female and male adult and paediatric participants over 6 years of age.[1] “Paediatric” means children and adolescents.[1]

People must have acute rhinitis, rhinopharyngitis, or rhinosinusitis, and their illness must not need antibiotic therapy.[1] In simple terms, the study is for common short-term nose and throat infections or inflammation where antibiotics are not considered necessary.[1]

Study design and phase

This is a prospective, controlled, randomized, double blind, two-arm, parallel-group, multicentre study.[1] “Prospective” means the study follows people forward in time after they join.[1] “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.[1]

“Two-arm” means there are two groups in the study, and “parallel-group” means the groups are followed at the same time.[1] “Multicentre” means the study is run at more than one site.[1]

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.[1]

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.[1] Baseline means the starting point before treatment effects are measured.[1]

The symptoms being tracked are nasal obstruction, rhinorrhea, thick mucus, sneezing, and cough.[1] Rhinorrhea means a runny nose or drainage from the nose.[1]

The questionnaire is used at Baseline, Day 2, Day 3, Day 4, and Day 8, so researchers can see how symptoms change over time.[1]

Trial status and size

The trial status is Authorised.[1] The planned enrollment is 248 participants.[1]

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.[1]

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.[1] The study focuses on practical symptoms that matter in daily life, such as blocked nose, runny nose, mucus, sneezing, and cough.[1]

Because the trial is randomized and double blind, the results are intended to be fair and less biased.[1] The main question is whether SODIUM SULFIDE NONAHYDRATE can improve symptoms better than placebo in this patient group.[1]

Trial ID Phase Condition studied Status Enrollment
2024-516284-90-00 Phase 3 Acute rhinitis, rhinopharyngitis, rhinosinusitis not requiring antibiotic therapy Authorised 248

FAQ

  • What is being studied in trials of SODIUM SULFIDE NONAHYDRATE? The trials are studying a nasal spray compared with placebo. Researchers want to see if it improves common cold-type nasal symptoms in people with acute rhinitis, rhinopharyngitis, and rhinosinusitis.
  • Who can take part in these trials? The study includes female and male adults and children over 6 years old. Participants must have acute rhinitis, rhinopharyngitis, or rhinosinusitis that does not require antibiotic therapy.
  • What phase is the trial? The trial is a Phase 3 study. Phase 3 trials usually test how well a treatment works in a larger group of people.
  • What are the researchers measuring? The main measure is change in nasal symptoms such as blockage, runny nose, thick mucus, sneezing, and cough. These symptoms are checked with a questionnaire over several days.
  • Is the study randomized and blinded? Yes. It is randomized, double blind, and placebo controlled. That means people are assigned by chance, and neither the participants nor the study team knows who gets the study spray or placebo during the trial.

Ongoing Clinical Trials on SODIUM SULFIDE NONAHYDRATE

  • Study of Actisoufre nasal spray containing sodium sulfide and saccharomyces extract for adults and children over 6 years with acute rhinitis, rhinopharyngitis, and rhinosinusitis

    Not yet recruiting

    1 1 1
    Investigated drugs:
    Poland

Glossary

  • Acute rhinitis: A short-term inflammation of the nose that can cause a blocked or runny nose, sneezing, and irritation.
  • Rhinopharyngitis: Inflammation of the nose and throat at the same time, often with cold-like symptoms.
  • Rhinosinusitis: Inflammation of the nose and sinus areas, which can cause congestion, mucus, and facial discomfort.
  • Antibiotic therapy: Treatment with antibiotics. In this trial, the condition does not need antibiotics.
  • Placebo: A look-alike treatment with no active study drug, used to compare results fairly.
  • Randomized: Assigned by chance to one treatment group or another, not by choice.
  • Double blind: Neither the participant nor the study team knows which treatment the person receives during the study.
  • Phase 3: A later stage of clinical research that tests how well a treatment works and continues to monitor safety.
  • Enrollment: The number of people planned or included in the study.
  • Common Cold Symptoms Severity Questionnaire: A survey used to rate how bad symptoms are, such as blockage, runny nose, thick mucus, sneezing, and cough.

References

  1. https://clinicaltrials.gov/study/2024-516284-90-00