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 study about?

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.

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 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 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 Continued treatment – Days 5-7

Continue using the nasal spray 3 times daily in each nostril

Total treatment duration is 7 days

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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Vitamed Galaj I Cichomski Sp. j. Bydgoszcz Poland
Centrum Medyczne Intercor Sp. z o.o. Bydgoszcz Poland
Clinical Medical Research Sp. z o.o. Katowice Poland
Centrum Medyczne Clw-Med Aneta Cichomska I Joanna Luka-Wendrowska Sp. j. Grudziadz Poland
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p. Wroclaw Poland
Centrum Zdrowia Dziecka I Rodziny Im. Jana Pawla II W Sosnowcu Sp. z o.o. Sosnowiec Poland
Salve Medica Sp. z o.o. S.K. Lodz Poland
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Mbffiupvd Ilwynsryh Jaksice Poland
Kmzi Kvvmninjk Vcdyehrp Jchcwgjywvk Czestochowa Poland
Kvve Scn z ohrd Wołomin Poland
Pmizrzfowoi Glvirpwue Sdb z olcc Grudziadz Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Poland Poland
Not yet recruiting
17.09.2025

Trial locations

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.

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 ID:
2024-516284-90-00
Protocol code:
ARG-01-2024
Trial Phase:
Therapeutic confirmatory (Phase III)

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