Study on Inhaled Tobramycin and Colistimethate Sodium for Adults with Chronic Bronchial Infection in Bronchiectasis

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What is this study about?

This clinical trial is focused on studying a lung condition called bronchiectasis, which involves the widening and damage of the airways in the lungs, leading to chronic infections. The study aims to explore the effectiveness of inhaled antibiotics in treating adults with this condition. The antibiotics being tested are tobramycin and colistimethate sodium, both administered as a nebulizer solution, which means they are inhaled as a mist. These medications are compared to a placebo to see if they help reduce the number of bacteria in the lungs.

The purpose of the study is to determine if patients with chronic bronchial infection, after receiving a course of targeted oral or intravenous treatment, experience a reduction in bacterial growth when treated with inhaled antibiotics. Participants will receive treatment over a period of 48 weeks. During this time, they will be monitored to assess the impact of the inhaled antibiotics on their lung health.

Participants in the study will be adults aged 20 to 90 years who have been diagnosed with bronchiectasis and have had at least two positive sputum cultures for the same germ in the past year. The study will help understand if inhaled antibiotics can be an effective strategy for managing chronic bronchial infections in people with bronchiectasis.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and ensuring the presence of bronchiectasis with chronic bronchial infection.

Eligibility is based on criteria such as age (20 to 90 years), previous positive sputum cultures, and current follow-up by a specialized unit.

2 baseline evaluation

A baseline evaluation is performed to establish the current state of health. This involves measuring the number of colony-forming units (CFU) in the sputum, which indicates the level of bacterial infection.

3 treatment phase

The treatment phase involves the administration of inhaled antibiotics. The medications used are tobramycin and colistimethate sodium, both delivered through inhalation.

The specific dosage and frequency of administration are determined by the study protocol and are designed to reduce the number of CFUs compared to a placebo group.

4 follow-up evaluations

Regular follow-up evaluations are conducted to monitor the effectiveness of the treatment. These evaluations include repeated measurements of CFUs to assess changes in bacterial infection levels.

5 final assessment

At the end of the study period, a final assessment is performed. This includes a comprehensive evaluation of the treatment’s impact on the infection and overall health status.

Who Can Join the Study?

Adult patients with bronchiectasis. This is a condition where the airways in the lungs become widened and can lead to infections.
Age between 20 to 90 years.
Both men and women can participate.
Must have at least 2 sputum cultures in the last year that show the same germ. A sputum culture is a test to find germs that cause infection in the lungs.
Must be under follow-up by the Multidisciplinary Bronchiectasis Unit of Hospital del Mar.
The severity of bronchiectasis and flare-ups should be assessed using current scales like BSI, FACED, and EFACED. These are tools used by doctors to measure how severe the condition is.
All patients who meet these criteria can join, no matter what other treatments they are on, such as inhaled corticosteroids, bronchodilators, oral antibiotics like azithromycin, or if they are doing respiratory physiotherapy. Inhaled corticosteroids and bronchodilators are medicines to help open up the airways, and azithromycin is an antibiotic.
Must provide a signed and dated informed consent form. This means you agree to participate after understanding the study.
Must be willing to follow all study procedures and be available for the entire study duration.

Who Cannot Join the Study?

Patients who do not have adult bronchiectasis cannot participate. Bronchiectasis is a condition where the airways in the lungs become widened and scarred.
Patients who are not within the specified age range cannot participate. The age range includes adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may have a higher risk of harm or exploitation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Consorci Mar Parc De Salut De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	02.05.2024

Trial locations

Investigated drugs:

Inhaled Antibiotics
In this clinical trial, inhaled antibiotics are used to treat patients with chronic bronchial infections. These medications are delivered directly into the lungs through inhalation, allowing the antibiotics to target the infection more effectively. The goal is to reduce the number of bacteria present in the airways, which is measured by the reduction in colony-forming units. This treatment is being compared to a placebo to determine its effectiveness in managing chronic bronchial infections in patients with bronchiectasis.

Investigated diseases:

Bronchiectasis

Bronchiectasis – Bronchiectasis is a chronic condition where the walls of the bronchi, the large air passages from the windpipe to the lungs, become damaged and widened. This damage is often due to repeated infections or inflammation, leading to a build-up of mucus that can cause further infections. Over time, the airways lose their ability to clear out mucus, resulting in persistent cough, frequent lung infections, and shortness of breath. The disease progresses as the cycle of infection and inflammation continues, potentially leading to more severe lung damage. Patients may experience symptoms such as fatigue, wheezing, and chest pain. Regular monitoring and management are essential to control symptoms and prevent complications.

Trial ID:

2023-510220-72-00

Protocol code:

BRONCHIPHARMA I

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Inhaled Tobramycin and Colistimethate Sodium for Adults with Chronic Bronchial Infection in Bronchiectasis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?