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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines the effectiveness of Actisoufre nasal spray in treating acute rhinitis (inflammation of the nasal passages), rhinopharyngitis (inflammation of the nose and throat area), and rhinosinusitis (inflammation of the nose and sinuses) that do not require antibiotic treatment. The study will test whether the nasal spray containing sodium sulfide nonahydrate and Saccharomyces cerevisiae extract can help reduce symptoms like nasal congestion, runny nose, and thick mucus.

The purpose of this research is to evaluate how well Actisoufre nasal spray works compared to placebo when used three times daily in each nostril for seven days. The study involves both adults and children over 6 years old who have developed sudden symptoms of nose and throat inflammation within the previous 48 hours.

During the study, participants will use either Actisoufre nasal spray or placebo. They will need to report their symptoms, including how well they sleep and their overall quality of life. The researchers will track any changes in symptoms, particularly focusing on improvements in nasal congestion, runny nose, and other related symptoms over the course of treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and starting treatment

    On the first day (Day 1), you will receive either Actisoufre nasal spray or a placebo (inactive substance) in a pressurized container

    You will need to use the nasal spray 3 times daily in each nostril

    You will complete the Common Cold Symptoms Severity Questionnaire to record your symptoms

    Your quality of life will be assessed using a simple scale

    You will be asked about immediate relief after using the product

  2. Step 2

    Daily monitoring - Days 2-3

    Continue using the nasal spray 3 times daily in each nostril

    Complete daily symptom questionnaires

    Record your sleep quality

    Report any immediate relief after using the product

  3. Step 3

    Day 4 assessment

    Complete the symptoms questionnaire

    Assess your quality of life

    Report your sleep quality

    Record any immediate relief after using the product

    Report any additional medications used

  4. Step 4

    Continued treatment - Days 5-7

    Continue using the nasal spray 3 times daily in each nostril

    Total treatment duration is 7 days

  5. Step 5

    Final assessment - Day 8

    Complete final symptoms questionnaire

    Assess your quality of life

    Report your sleep quality

    Report any use of additional nasal decongestants

    Review any side effects or health changes experienced during the study

Who can join the trial?

7 criteria

  • Patient (or legal guardian for ages 6-18) must sign an informed consent form
  • Age must be between 6 and 70 years old (includes both children and adults)
  • Both males and females can participate
  • Must have a clinical diagnosis of acute nasal condition with at least two of these symptoms appearing within the last 48 hours: - Blocked, obstructed or congested nose - Runny nose (including discharge from front or back of nose)
  • Must be able to understand and answer questions about symptoms
  • Must be willing to use acceptable birth control methods during the study, such as: - Progestogen-only oral contraception - Male or female condom (with or without spermicide) - Cap, diaphragm, or sponge with spermicide - For adolescents up to 16 years, sexual abstinence is acceptable
  • Must be able to understand study information and follow all study procedures

Who cannot join the trial?

15 criteria

  • Age below 6 years
  • Having conditions requiring antibiotic treatment
  • Known allergies to any components of the nasal spray
  • Current participation in other clinical trials
  • Severe nasal obstruction preventing the use of nasal spray
  • Presence of bacterial infection in the nose or sinuses
  • Recent nasal surgery (within last 3 months)
  • Use of other nasal medications in the past 7 days
  • Pregnancy or breastfeeding
  • Serious underlying medical conditions that could affect the study results
  • History of severe reactions to nasal medications
  • Inability to follow study instructions or attend follow-up visits
  • Current chronic sinusitis (long-term inflammation of sinuses)
  • Use of medications that could interact with the study treatment
  • Presence of nasal polyps (abnormal tissue growths in the nose)
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Investigated drugs

Actisoufre is a nasal spray delivered in a pressurized container. It is used to treat acute rhinitis (inflammation of the nasal passages), rhinopharyngitis (inflammation of both the nose and throat area), and rhinosinusitis (inflammation of the nose and sinuses) in cases that don't require antibiotic treatment. This medication is suitable for both adults and children over 6 years of age. The spray helps reduce inflammation and relieve symptoms associated with these upper respiratory conditions.

What is already known about the treatment

Actisoufre - A nasal spray medication delivered via a pressurized container, designed for treating acute rhinitis, rhinopharyngitis, and rhinosinusitis when antibiotic therapy is not required. The medication is administered three times daily into each nostril, making it suitable for both adults and children over 6 years of age. Based on clinical trials, this treatment is being evaluated as a potential alternative to conventional therapies for upper respiratory tract conditions, focusing on cases where bacterial infection is not present. The medication represents a targeted approach to managing nasal and sinus symptoms through direct application to the affected areas.

Investigated diseases

  • Acute rhinitis

    An inflammation of the nasal passages characterized by nasal congestion, runny nose, and sneezing. The condition typically develops rapidly and causes the nasal mucosa to become swollen and produce excess mucus. Common symptoms include nasal obstruction, rhinorrhea, and occasional thick mucus formation.

  • Rhinopharyngitis

    An inflammatory condition affecting both the nasal passages and pharynx (throat area). The condition causes irritation and swelling of the nasal and throat tissues, leading to symptoms such as nasal congestion, sore throat, and increased mucus production. Patients often experience both nasal symptoms and throat discomfort simultaneously.

  • Rhinosinusitis

    An inflammatory condition affecting the nasal passages and paranasal sinuses. The condition involves swelling of the nasal and sinus membranes, which can lead to blocked nasal passages and increased mucus production. Typical symptoms include facial pressure, nasal congestion, and changes in mucus consistency.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516284-90-00Protocol codeARG-01-2024Estimated enrolment248 patientsSponsorLaboratoires Grimberg

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