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SACCHAROMYCES CEREVISIAE TYPE D EXTRACT

Questo articolo riassume gli studi clinici su SACCHAROMYCES CEREVISIAE TYPE D EXTRACT, valutato in una forma di spray nasale in pazienti con rinite acuta, rinofaringite e rinosinusite che non richiedono antibiotici. I trial mirano soprattutto a misurare efficacia sui sintomi nasali e includono adulti e bambini sopra i 6 anni.

Table of contents

Trial overview

The available study investigates SACCHAROMYCES CEREVISIAE TYPE D EXTRACT as a nasal spray in a pressurized container for people with acute rhinitis, rhinopharyngitis, and rhinosinusitis that do not require antibiotic therapy.[1]

The study compares the active spray with placebo, which is a look-alike treatment used for comparison.[1]

The trial is designed to see whether the spray can improve nasal and common cold-like symptoms over a short treatment period.[1]

Who can participate

The study includes female and male adults and paediatric participants over 6 years old.[1]

People in the trial must have one of the target conditions: acute rhinitis, rhinopharyngitis, or rhinosinusitis, and their illness must not need antibiotics.[1]

This means the study focuses on patients with upper airway symptoms that are being managed without antibiotic treatment.[1]

Study design and phase

This is a Phase 3 study, which means it is a later-stage clinical trial used to test how well a treatment works in a larger group of patients.[1]

The trial is prospective, controlled, randomized, double blind, two-arm, parallel-group, and multicentre.[1]

  • Prospective means the study follows people forward in time after they join the trial.[1]

  • Randomized means participants are assigned by chance to one of the study groups.[1]

  • Double blind means neither the participants nor the study team know who is receiving the study spray or placebo during the trial.[1]

  • Parallel-group means the two groups are treated at the same time so their results can be compared.[1]

  • Multicentre means the study is carried out in more than one study site.[1]

The brief study summary states that the spray was planned to be applied three times daily into each nostril for 7 days, compared with placebo.[1]

What is being measured

The main outcome is the change in nasal symptoms from the start of the study to Day 4, measured in the treatment group and the placebo group.[1]

The symptoms being tracked include nasal obstruction, rhinorrhea, thick mucus, sneezing, and cough.[1]

These symptoms are rated with the Common Cold Symptoms Severity Questionnaire (CCSS), which is a tool used to score how severe the symptoms are.[1]

The CCSS is assessed at Baseline (Day 1), Day 2, Day 3, Day 4, and Day 8, so the study can follow how symptoms change over time.[1]

Status and study size

The trial status is Authorised, showing that the study has been approved to proceed.[1]

The planned enrollment is 248 participants, which is the number of people the study aims to include.[1]

Because the study compares SACCHAROMYCES CEREVISIAE TYPE D EXTRACT with placebo in a defined patient group, it is focused on whether the spray improves symptoms better than no active treatment.[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 the clinical trials? The trials study SACCHAROMYCES CEREVISIAE TYPE D EXTRACT in a nasal spray form. They compare it with placebo to see whether it improves cold-like nasal symptoms.
  • Who can take part in these studies? The study includes female and male adults and children over 6 years old. Participants have acute rhinitis, rhinopharyngitis, or rhinosinusitis that does not need antibiotic therapy.
  • What phase is the trial? This is a Phase 3 study. Phase 3 trials are larger studies that test how well a treatment works in a real patient group.
  • What outcome is being measured? The main outcome is the change in nasal symptoms such as blockage, runny nose, thick mucus, sneezing, and cough. These symptoms are measured with a symptom questionnaire at several time points.
  • How many people are planned for the study? The planned enrollment is 248 participants. This gives the study enough people to compare the treatment group with the placebo group.

Sperimentazioni cliniche in corso su SACCHAROMYCES CEREVISIAE TYPE D EXTRACT

  • Studio sull’efficacia dello spray nasale Actisoufre (solfuro di sodio nonaidrato ed estratto di Saccharomyces cerevisiae) contro placebo in pazienti sopra i 6 anni con rinite acuta, rinofaringite e rinosinusite

    Arruolamento non iniziato

    1 1 1
    Farmaci in studio:
    Polonia

Glossario

  • Acute rhinitis: A short-term inflammation of the nose that can cause a blocked or runny nose, sneezing, and discomfort.
  • Rhinopharyngitis: An infection or irritation affecting both the nose and the throat area.
  • Rhinosinusitis: Swelling or infection in the nose and sinus cavities, which can cause pressure, mucus, and congestion.
  • Antibiotic therapy: Treatment with antibiotics, which are medicines used for some bacterial infections. The study includes people whose illness does not need this treatment.
  • Placebo: A look-alike treatment with no active study medicine, used for comparison.
  • Randomized: Participants are assigned by chance to a study group, so the groups can be compared fairly.
  • Double blind: Neither the participants nor the study team know who gets the study treatment or placebo during the trial.
  • Parallel-group: Two groups are studied at the same time, each receiving a different treatment.
  • Primary outcome: The main result the study is designed to measure.
  • Common Cold Symptoms Severity Questionnaire (CCSS): A questionnaire used to rate how bad common cold symptoms are over time.