Table of Contents

• Trial overview
• Who can participate
• Study design and phase
• What is being measured
• Treatment comparison
• What the trial may mean for patients

Trial overview

This article covers one authorised clinical trial of SACCHAROMYCES CEREVISIAE TYPE D EXTRACT in a nasal spray form called Actisoufre.^[1] The study is looking at acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not require antibiotic therapy.^[1]

The trial is designed to see whether the study treatment works better than placebo for easing nasal symptoms in children and adults.^[1] The planned enrollment is 248 participants.^[1]

Who can participate

The study includes female and male adults and paediatric patients over 6 years old.^[1] People must have acute rhinitis, rhinopharyngitis, or rhinosinusitis, and their illness must not need antibiotic therapy.^[1]

In simple terms, this means the trial is for people with short-term nose, throat, or sinus inflammation that is not thought to need antibiotics.^[1]

Study design and phase

This is a Phase 3 study.^[1] Phase 3 trials usually compare a treatment with a control group in a larger number of people to see how well it works.^[1]

The trial is described as prospective, controlled, randomized, double blind, two-arm, parallel-group, and multicentre.^[1] These terms mean the study follows patients forward in time, compares two groups, assigns people by chance, keeps both patients and researchers unaware of group assignment, runs two groups side by side, and takes place at more than one site.^[1]

• Randomized means participants are placed into a group by chance, which helps make the groups fair to compare.^[1]
• Double blind means neither the participant nor the study team knows who receives the study treatment or placebo during the trial.^[1]
• Parallel-group means the two groups are followed at the same time, so results can be compared directly.^[1]
• Multicentre means the trial is carried out at more than one location.^[1]

What is being measured

The main outcome is the change in nasal symptoms from the start of the study to Day 4.^[1] The symptoms being scored include nasal blockage, runny nose, thick mucus, sneezing, and cough.^[1]

Researchers use the Common Cold Symptoms Severity Questionnaire, also called CCSS, to measure these symptoms at Baseline (Day 1), Day 2, Day 3, Day 4, and Day 8.^[1] A questionnaire is a set of questions or scores used to track how bad symptoms are over time.^[1]

The primary objective is to test the efficacy of the nasal spray compared with placebo when used three times a day in each nostril for 7 days.^[1] Efficacy means how well the treatment works in the study setting.^[1]

Treatment comparison

The study compares two arms: ACTISOUFRE, which is the study nasal spray form of SACCHAROMYCES CEREVISIAE TYPE D EXTRACT, and a placebo nasal spray.^[1] A placebo is made to look like the treatment but does not contain the active study drug.^[1]

Because the trial is double blind, the comparison is designed to reduce bias in symptom scoring and result reporting.^[1] This helps researchers judge whether any improvement is linked to the study treatment rather than expectations alone.^[1]

What the trial may mean for patients

This research is focused on common upper airway illnesses that are usually short term but can still cause bothersome symptoms like congestion and runny nose.^[1] The study is especially relevant for adults and children over 6 years old who have these symptoms and do not need antibiotics.^[1]

For patients, the key question in this trial is whether the nasal spray can reduce symptom severity faster or more than placebo.^[1] The trial does not report final results in the source data provided, so the main focus here is the study plan and what it aims to measure.^[1]