Table of contents
- Trial overview
- Who can participate
- Study design and phase
- What is being measured
- Trial status and size
- Why this trial matters for patients
Trial overview
The available clinical trial for SODIUM SULFIDE NONAHYDRATE is a prospective, controlled, randomized, double-blind, two-arm, parallel-group, multicentre Phase 3 study.[1]
It is testing Actisoufre nasal spray in a pressurized container against placebo in people with acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not require antibiotic therapy.[1]
The trial is designed to evaluate whether the study treatment improves symptoms better than placebo.[1]
Who can participate
The study includes female and male adults and paediatric participants older than 6 years.[1]
People in the trial must have one of the studied conditions and must not need antibiotic therapy.[1]
This means the trial is focused on patients with common upper airway infections or inflammation that are being managed without antibiotics.[1]
Study design and phase
This is a randomized study, which means participants are assigned by chance to the treatment group or the placebo group.[1]
It is also double blind, so neither the participants nor the study team know who gets the study spray and who gets placebo during the trial.[1]
The study uses a parallel-group design, so the two groups are followed at the same time and compared directly.[1]
The trial is in Phase 3, which usually means the treatment is being tested in a larger group to better understand how well it works compared with a control group.[1]
The study is multicentre, so it is carried out at more than one site.[1]
What is being measured
The main endpoint, also called the primary outcome, is the change in nasal symptoms from baseline to Day 4.[1]
Symptoms measured include nasal obstruction, rhinorrhea, thick mucus, sneezing, and cough.[1]
These symptoms are assessed with the Common Cold Symptoms Severity Questionnaire (CCSS), a questionnaire used to score how severe the symptoms are.[1]
The CCSS is used at baseline on Day 1 and again on Day 2, Day 3, Day 4, and Day 8, so researchers can follow symptom changes over time.[1]
The trial compares the symptom changes in the treatment group and the placebo group to see whether the nasal spray gives better relief.[1]
Trial status and size
The study status is Authorised, meaning it has been approved to proceed according to the trial record.[1]
The planned enrollment is 248 participants.[1]
This number gives the researchers a group large enough to compare outcomes between the two study arms.[1]
Why this trial matters for patients
This trial is focused on a common set of upper respiratory symptoms that can be uncomfortable but do not need antibiotics.[1]
Because it includes both adults and children older than 6 years, the study is relevant to a broad patient population.[1]
The main question is simple: does the study spray improve nasal and cold-like symptoms more than placebo over the first week of treatment?[1]
