AuthorisedTherapeutic use (Phase IV)Interventional

PHARMACOLOGICAL STRATEGIES OF INHALED ANTIBIOTHERAPY IN BRONCHIECTASIS WITH CHRONIC BRONCHIAL INFECTION: BRONCHIPHARMA STUDY.

This study, called BRONCHIPHARMA, is for adults who have a lung condition called bronchiectasis and suffer from long-term lung infections. Researchers are investigating different inhaled medicines, including tobramycin and colistimethate sodium, to see how effective they are at reducing germs in the lungs. They will compare these medicines with a simple saline solution, which is a sterile salt water. This is a Phase IV trial, meaning these treatments are already in use, but researchers want to understand more about their best use in real-world settings. The main goal is to find out which approach works best to control the amount of infection in the lungs.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Consorci Mar Parc De Salut De Barcelona

Enrolment target

Start

03 Jun 2024

Adult bronchiectasis

What is this study about?

If you have bronchiectasis, you may know that managing ongoing lung infections can be a real challenge. This study is designed specifically for adults living with this condition and who experience these long-term infections. The main aim is to carefully examine the best ways to deliver medicines that kill germs directly into your lungs using an inhaler.

The researchers are looking at two specific germ-killing medicines, tobramycin and colistimethate sodium. These are well-known treatments for lung infections. They want to compare how well these inhaled medicines work against using a simple saline solution (sterile salt water often used to help clear airways). By comparing these, they hope to learn which method is most effective at reducing the amount of infection in your lungs over time.

This study is a ‘Phase IV’ trial, which means the general safety and effectiveness of these medicines are already known. Instead, this trial focuses on understanding the best ways to use them in people with bronchiectasis in a real-world setting. The information gathered will help doctors make better decisions about treating ongoing lung infections in people with bronchiectasis, potentially leading to improved health and fewer infection flare-ups.

Key takeaways

Study for adults with bronchiectasis and ongoing lung infections.
Compares different inhaled germ-killing medicines.
Aims to find best ways to reduce germs in the lungs.
It's a Phase IV study, looking at treatments already in use.
Participation involves regular clinic visits and health checks.

Who may be eligible?

This study is particularly for adults who have been diagnosed with bronchiectasis, a condition where your airways become widened and scarred, making you more prone to infections. You must also have ongoing, long-term lung infections.

To join, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

There might be other specific health requirements or conditions that would prevent you from taking part, but these details would be discussed fully with the study team and your doctor.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of adult bronchiectasis?
Do you experience chronic (long-term) lung infections?
Are you able to use an inhaled medicine device?
Are you generally willing to attend regular clinic appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you choose to take part in this study, you would receive one of the inhaled treatments (either tobramycin, colistimethate sodium, or a saline solution) for a period as specified by the study. The treatments are administered using an inhaler. You would attend regular appointments at the study clinic where various tests would be carried out. This would likely include providing samples (e.g., sputum samples to check for germs) and having your lung function checked. The study team would closely monitor your health and any effects of the treatment. The total duration of your participation, including follow-up, would be clearly explained by the research staff.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining access to specific treatments and receiving close monitoring of your lung health. However, there are also potential risks, including possible side effects from the inhaled medicines, although these will be carefully explained to you. You might also find the study visits and tests time-consuming. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is bronchiectasis?

Bronchiectasis is a long-term lung condition where the airways become damaged and widened, making it harder to clear mucus and leading to infections.

What kind of medicines are being tested?

The study is testing two inhaled germ-killing medicines called tobramycin and colistimethate sodium, as well as a sterile salt water solution (saline).

How will the medicines be given?

The medicines will be given using a device called an inhaler, similar to how some people take asthma medicines.

What does 'Phase IV' mean?

Phase IV means the medicines are already approved and in use, but the study is looking at the best ways to use them for specific conditions like bronchiectasis.

Will I know which treatment I'm getting?

In many studies like this, participants are often randomly assigned to a treatment group, and sometimes you and your doctors might not know which specific treatment you're receiving until after the study is over, to keep the results fair.