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

Fast replyRegistered drugNo placebo

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What is this trial about?

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

This clinical trial is focused on studying a lung condition called Non-Cystic Fibrosis Bronchiectasis, which is a disease where the airways in the lungs become damaged and widened, leading to a build-up of mucus and frequent lung infections. The study is particularly interested in patients who have this condition along with infections caused by a type of bacteria known as Pseudomonas Aeruginosa or other harmful microorganisms. The trial will test two new treatments, known by their code names RESP302 and RESP303, which are formulations of a substance called sodium nitrite. These treatments are delivered as a nebulizer solution, which means they are inhaled as a mist using a device called the PARI eFlow Nebulizer System.

The purpose of the study is to evaluate how safe and tolerable these new treatments are for patients with this lung condition. Participants will use the nebulizer to inhale the treatment, and some may receive a placebo for comparison. The study will also involve the use of a common medication called salbutamol sulfate, which is often used to help open the airways in the lungs. This medication is delivered using an inhaler. Throughout the study, participants will be monitored for any side effects and changes in their health, including vital signs like blood pressure and heart rate.

The trial will take place over a period of time, during which participants will be asked to attend several study visits. During these visits, they will undergo various assessments to check their health and the effects of the treatment. The study aims to gather important information that could help improve the treatment of Non-Cystic Fibrosis Bronchiectasis in the future.

The research process

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

Step 1
Joining the study
Upon joining the study, consent is required to participate in all study-related procedures.
Eligibility includes being between 18 and 75 years old, having a history of bronchiectasis, and confirmed high levels of specific respiratory microorganisms.
Step 2
Initial assessment
An initial assessment is conducted to confirm the presence of high-titre respiratory microorganisms.
Participants must be able to produce sputum daily and self-administer the inhaler and nebuliser.
Step 3
Medication administration
The study involves the use of nebulised solutions: RESP302, RESP303, and salbutamol.
All medications are administered through inhalation using a nebuliser.
Step 4
Monitoring and follow-up
Regular monitoring of treatment-emergent adverse events, changes in laboratory values, and vital signs is conducted.
Participants' plasma levels are measured to assess drug concentration and exposure over time.
Step 5
Completion of the study
The study is estimated to conclude by December 31, 2025.
Participants will be informed of the study's outcomes and any relevant findings.

Who can join the trial?

8 criteria

Provide written, informed consent before any study-related procedures and agree to participate in all study activities.
Be between 18 and 75 years old.
Have a clinical history of **bronchiectasis**, which is a lung condition that affects one or more parts of the lungs, confirmed by a **CT scan** (a detailed imaging test) and a radiology report done within the last 5 years.
Have confirmed high levels of **respiratory PPMs** (potentially pathogenic microorganisms) at screening, specifically **Pseudomonas Aeruginosa**, with a count of at least 100,000 CFU/mL, as determined by a central laboratory.
If you or your partner can have children and engage in heterosexual intercourse, you must agree to use the study's defined methods of contraception.
Be able to produce **sputum** (a mixture of saliva and mucus coughed up from the respiratory tract) spontaneously every day.
Be able to self-administer a **SABA inhaler** (a type of inhaler used for quick relief of breathing problems) and a study **nebuliser** (a device that turns liquid medicine into a mist) effectively, as judged by the study investigator after training.
Be appropriately vaccinated against **influenza** (the flu) and **pneumococcus** (a type of bacteria that can cause lung infections) at least 14 days before the first day of the study. This requirement applies only if the screening visit is between September and March and the vaccines for that year are available.

Who cannot join the trial?

4 criteria

Patients who have a different lung condition other than Non-Cystic Fibrosis Bronchiectasis cannot participate. This is a lung condition where the airways become widened and scarred.
Patients who do not have an infection with Pseudomonas Aeruginosa or other harmful bacteria in their lungs cannot participate. These are types of bacteria that can cause lung infections.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who cannot give consent or are in a dependent relationship with the study staff, cannot participate.

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Responsive
Spitalul Clinic Judetean De Urgenta Cluj
Cluj Napoca, Romania

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Investigated drugs

RESP30X is a medication being tested in this clinical trial. It is a formulation of nitric oxide that is delivered through a nebulizer. The purpose of this medication is to evaluate its safety and how well it is tolerated by patients who have non-cystic fibrosis bronchiectasis. This condition involves chronic lung infections, and the trial focuses on patients who have specific bacteria, such as Pseudomonas aeruginosa, in their respiratory system. The goal is to see if RESP30X can help manage these infections and improve the patients' lung health.

What is already known about the treatment

RESP30X – This medication is administered through nebulization, allowing the patient to inhale the drug directly into the lungs. Currently, RESP30X is being studied in clinical trials to determine its safety and effectiveness for treating non-cystic fibrosis bronchiectasis, particularly in patients with Pseudomonas aeruginosa or other harmful microorganisms. The main therapeutic use of RESP30X is to manage respiratory infections in these patients. At the molecular level, RESP30X works by delivering nitric oxide, which has antimicrobial properties, directly to the lungs to help reduce the bacterial load. It is classified pharmacologically as an antimicrobial agent.

Investigated diseases

Non-Cystic Fibrosis Bronchiectasis – This is a chronic lung condition where the airways become damaged and widened, leading to mucus build-up and frequent lung infections. It is not related to cystic fibrosis, but it shares some similar symptoms, such as persistent cough and sputum production. Over time, the repeated infections and inflammation can cause further damage to the airways, making it harder to clear mucus and increasing the risk of more infections. The presence of bacteria like Pseudomonas aeruginosa can worsen the condition, leading to more severe symptoms and complications. Patients may experience breathlessness, fatigue, and reduced quality of life due to the chronic nature of the disease. Regular monitoring and management are essential to help control symptoms and prevent further lung damage.