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Sodium Nitrite

Clinical trials investigating Sodium Nitrite are studying its use in people with non-cystic fibrosis bronchiectasis and harmful airway bacteria. These studies mainly look at safety, tolerability, and early signs of benefit in adults with confirmed respiratory infection. The trial data here focus on how the treatment is tested, who may take part, and which outcomes are measured.

Table of Contents

Trial overview

The source data describe one interventional clinical trial investigating Sodium Nitrite in a respiratory setting, although the study title uses the name RESP30X and includes inhaled formulations. The trial was designed to assess safety and tolerability in people with non-cystic fibrosis bronchiectasis and confirmed high-titre respiratory potentially pathogenic micro-organisms.[1]

This study was completed and enrolled 67 participants.[1]

Who was studied

The target population was people with non-cystic fibrosis bronchiectasis, which is a long-term lung condition where the airways are damaged and widened.[1]

The study also required confirmed high-titre respiratory potentially pathogenic micro-organisms (PPMs), including Pseudomonas aeruginosa or other similar germs that may cause disease.[1]

In simple terms, the trial focused on people who had both a chronic lung problem and evidence of harmful bacteria in the airways.[1]

What was tested in the trial

The interventions listed in the source data were RESP302, salbutamol, and RESP303, all given by inhalation use.[1]

The brief summary says the study aimed to assess the safety and tolerability of RESP30X in participants with confirmed high-titre respiratory PPMs.[1]

Safety means looking for unwanted health problems, while tolerability means how well people can receive the treatment without major difficulty.[1]

Outcomes measured

The primary outcomes included the incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs).[1]

TEAEs are health problems that begin or become worse after treatment starts.[1]

Researchers also measured changes in laboratory values, including haematology and clinical chemistry, at each time point.[1]

They further tracked changes in vital signs such as blood pressure, heart rate, temperature, respiratory rate, and oxygen saturation (SpO2).[1]

Trial phase and status

This was a Phase 1 trial, which is an early stage of clinical research that mainly checks safety and tolerability.[1]

The study status is listed as completed, so the planned testing and data collection were finished.[1]

What the trial means for patients

For patients, this trial shows that Sodium Nitrite was being explored in a small early study for a specific lung condition linked to airway bacteria.[1]

The main question was not whether the treatment cures disease, but whether it can be studied safely in this group and what short-term changes appear in tests and vital signs.[1]

Because the study was completed, its data can help researchers decide whether larger studies should be done later.[1]

Trial ID Phase Condition studied Status Enrollment
2023-508706-23-00 Phase 1 Non-cystic fibrosis bronchiectasis with Pseudomonas aeruginosa or other potentially pathogenic micro-organisms Completed 67

FAQ

  • What are clinical trials of Sodium Nitrite trying to find out? The trial data focus on safety and tolerability first. Researchers also measure laboratory results, vital signs, and oxygen levels to see how participants respond.
  • Who is the target population in these trials? The studied group includes people with non-cystic fibrosis bronchiectasis and confirmed high-titre respiratory potentially pathogenic micro-organisms, such as Pseudomonas aeruginosa. This means the trial is aimed at adults with a long-term lung condition and harmful bacteria in the airways.
  • What phase is the Sodium Nitrite trial? The trial listed here is a Phase 1 study. Phase 1 trials are early studies that mainly check safety and tolerability.
  • What outcomes are being measured in the trial? The main outcomes include treatment-emergent adverse events, changes in blood tests, and changes in vital signs such as blood pressure, heart rate, temperature, breathing rate, and oxygen saturation. These help researchers understand safety and short-term effects.
  • Is the trial completed? Yes, the trial in the source data is marked as completed. That means the planned study visits and measurements were finished.

Ongoing Clinical Trials on Sodium Nitrite

  • Study on the Safety and Tolerability of Nebulised Sodium Nitrite Formulations in Patients with Non-Cystic Fibrosis Bronchiectasis and Pseudomonas Aeruginosa

    Not recruiting

    1 1 1
    Investigated drugs:
    Bulgaria Poland Romania

Glossary

  • Non-cystic fibrosis bronchiectasis: A long-term lung condition where the airways become widened and damaged, which can make it easier for mucus and germs to stay in the lungs.
  • Pseudomonas aeruginosa: A type of bacteria that can cause lung infection, especially in people with chronic lung disease.
  • Potentially pathogenic micro-organisms (PPMs): Germs that may cause disease or worsen symptoms, especially in the airways.
  • High-titre: A high amount or high level of bacteria found in a sample.
  • Interventional study: A clinical trial where researchers give a treatment and then measure what happens.
  • Phase 1: An early trial phase that mainly checks safety, tolerability, and basic effects in people.
  • Safety: How well a treatment can be used without causing serious harm.
  • Tolerability: How easy a treatment is for people to take or receive, based on side effects and comfort.
  • Treatment-emergent adverse events (TEAEs): Health problems that start or get worse after treatment begins.
  • Oxygen saturation (SpO2): A measure of how much oxygen is in the blood.

References

  1. https://clinicaltrials.gov/study/2023-508706-23-00