A study testing the safety and effectiveness of inhaled hypochlorous acid in patients with chronic airway infections

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What is this study about?

This study is looking at chronic airway infections, which are long-lasting infections in the breathing passages. The study will test a treatment called SS0331, which contains hypochlorous acid as its active ingredient. This medication is given as a solution that is breathed in through a device called a nebuliser, which turns liquid medicine into a fine mist that can be inhaled into the lungs. The nebuliser system includes the Aerogen Solo nebuliser, Aerogen Ultra breathing chamber with mouthpiece, and Aerogen UBS controller.

The study has two parts. The first part will test the safety of SS0331 in healthy people by giving them increasing doses of the medicine three times a day for five days to see if it causes any unwanted effects. The purpose of the study is to see if SS0331 can reduce the amount of bacteria in the sputum, which is the mucus that people cough up from their lungs. The second part will test how well the treatment works in people who have chronic airway infections related to conditions such as cystic fibrosis, primary ciliary dyskinesia, or non-cystic fibrosis bronchiectasis. These are conditions where the airways are damaged or do not work properly, making it easier for infections to develop and persist.

During the study, participants will receive the nebulised SS0331 treatment three times daily for five days. The researchers will collect sputum samples to measure the number of bacteria present before and after treatment to see if the medication helps reduce the infection. They will also monitor participants for any side effects or unwanted reactions to the treatment. The study will help determine if this inhaled treatment is safe and whether it might be helpful for people living with chronic airway infections.

1 Treatment period with inhaled medication

You will receive SS0331, which is a solution containing hypochlorous acid. This medication is designed to reduce bacteria in your airways.

The medication will be administered through inhalation using a nebuliser. A nebuliser is a device that turns liquid medication into a fine mist that you breathe in through a mouthpiece or mask.

You will inhale the medication three times per day for a period of five days.

The specific dose you receive will depend on which phase of the trial you are participating in. In the first phase, healthy participants will receive increasing doses to assess safety. In the second phase, patients with chronic airway infections will receive the medication to evaluate its effect on reducing bacteria.

2 Sputum sample collection

If you are participating in the second phase of the trial, you will need to provide sputum samples. Sputum is the thick mucus that you cough up from your lungs.

A sputum sample will be collected at the beginning of the trial to measure the baseline level of bacteria in your airways.

Additional sputum samples will be collected after treatment to measure changes in the amount of bacteria present.

You will need to be able to cough up at least 1 gram of sputum naturally for these collections.

3 Safety monitoring throughout the trial

Throughout your participation, you will be monitored for any adverse events. An adverse event is any unwanted or harmful reaction that occurs during the trial.

The trial team will record the type, frequency, and severity of any adverse events that occur.

This monitoring is particularly important in the first phase of the trial, where the primary focus is on assessing the safety and tolerability of the medication.

4 Assessment of treatment effects

If you are participating in the second phase, the main assessment will focus on whether the medication reduces the density of bacteria in your sputum.

The bacterial density will be measured in colony-forming units per gram, which is a way to count how many bacteria are present in your sputum sample.

The results from samples taken after treatment will be compared to your baseline sample to determine if the medication has reduced the bacterial load in your airways.

Who Can Join the Study?

  • You must be 18 years of age or older
  • For the first phase: You must be a healthy person between 18 and 55 years of age
  • For the first phase: Your Body Mass Index (a measure of body fat based on your height and weight) must be between 18.5 and 29.9
  • For the second phase: You must be an adult with chronic airway infection (a long-lasting infection in the breathing passages)
  • For the second phase: You must have one of these conditions: CF (cystic fibrosis, a genetic disease affecting the lungs), PCD (primary ciliary dyskinesia, a condition affecting the tiny hairs in airways), or NCFB (non-cystic fibrosis bronchiectasis, a condition where airways are damaged and widened)
  • For the second phase: Your underlying lung disease must be stable (not getting worse at the time of joining)
  • For the second phase: You must be able to cough up sputum (mucus from your lungs) on your own, at least 1 gram
  • For the second phase: The sputum you cough up must contain a certain amount of bacteria (at least 5 log10 colony-forming units per gram, which is a way to measure how many bacteria are present)
  • Both male and female participants can take part in this study

Who Cannot Join the Study?

  • No exclusion criteria have been specified for this clinical trial in the provided information.

Where you can join this trial?

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Site Name City Country Status
Ddunsvlnd Anx Copenhagen Denmark

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

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
02.02.2026

Trial locations

Investigated drugs:

SS0331 is an inhaled medication that is given through a nebulizer, which is a device that turns liquid medicine into a mist that you breathe in. This medication is being tested to see if it can help reduce the amount of bacteria in the lungs of people who have long-term lung infections. The study is looking at whether this treatment is safe and whether it can help fight bacterial infections in the airways.

Investigated diseases:

Chronic Airway Infections – Chronic airway infections are long-lasting infections that affect the breathing passages in the lungs. These infections occur when harmful bacteria settle in the airways and persist over time, causing ongoing inflammation and damage to the respiratory system. The condition leads to increased mucus production and difficulty clearing secretions from the lungs. Patients experience repeated episodes of coughing, excess sputum production, and breathing difficulties. The bacteria multiply in the airways and form communities that are difficult for the body’s immune system to eliminate. Over time, the persistent infection can cause progressive damage to the lung tissue and airways.

Cystic Fibrosis – Cystic fibrosis is an inherited disorder that affects the cells producing mucus, sweat, and digestive fluids. The condition causes these secretions to become thick and sticky instead of thin and slippery. The abnormal mucus blocks the airways in the lungs, trapping bacteria and leading to repeated infections. The thick secretions also obstruct the pancreas and prevent digestive enzymes from reaching the intestines. Patients experience persistent coughing, frequent lung infections, and difficulty breathing. The disease affects multiple organ systems and requires ongoing management throughout life.

Primary Ciliary Dyskinesia – Primary ciliary dyskinesia is an inherited condition that affects the tiny hair-like structures called cilia that line the airways. These cilia normally move in coordinated waves to clear mucus and trapped particles from the respiratory tract. In this condition, the cilia do not move properly or are completely immobile, preventing effective clearance of mucus. The buildup of mucus creates an environment where bacteria can grow, leading to chronic respiratory infections. Patients experience persistent wet cough, nasal congestion, and recurring ear and sinus infections. The impaired mucus clearance results in progressive lung damage over time.

Non-Cystic Fibrosis Bronchiectasis – Non-cystic fibrosis bronchiectasis is a condition where the airways in the lungs become permanently widened and damaged. The walls of the airways become thickened and scarred, losing their ability to clear mucus effectively. Mucus accumulates in the damaged airways, creating a breeding ground for bacterial infections. Patients experience a chronic productive cough with large amounts of sputum and repeated chest infections. The condition leads to a cycle where infection causes more damage, and the damage makes infections more likely. The airways gradually lose their function, resulting in progressive breathing difficulties.

Trial ID:
2025-523875-48-00
Protocol code:
SIS-03
Trial Phase:
Human Pharmacology (Phase I) – Other

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