AuthorisedTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-blinded, Placebo-controlled, Parallel Group, Phase 2a Study to Assess the Activity, Safety, and Tolerability of SAR445399 in Adult Participants with Non-Cystic Fibrosis Bronchiectasis (NCFB).

Bronchiectasis is a long-term lung condition where the airways become widened, leading to thick mucus building up and causing frequent chest infections. This study is testing an experimental medicine called SAR445399 in adults with bronchiectasis that is not caused by cystic fibrosis. The main goal is to find out if this medicine can safely break down or clear mucus plugs in the lungs. Researchers will use detailed chest CT scans after 24 weeks to see if the plugs have reduced. They will also monitor breathing strength and track chest infections for up to 52 weeks. Participants will be randomly assigned to receive either the trial medicine or a dummy treatment (placebo). Neither you nor your study doctor will choose or know which one you receive. This ensures the results are completely fair and reliable.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

Start

23 Jun 2026

Non-cystic fibrosis bronchiectasis

What is this study about?

Bronchiectasis is a long-term lung condition where the breathing tubes widen and lose their natural shape. Because of this, the lungs struggle to clear everyday mucus. Over time, thick mucus builds up into sticky 'plugs'. These plugs make it harder to breathe and make you much more likely to get repeated chest infections, also known as flare-ups. While some people develop bronchiectasis from cystic fibrosis, many do not. This study focuses specifically on those with non-cystic fibrosis bronchiectasis, who urgently need new and better treatments.

Researchers are running this clinical trial to test a new medicine named SAR445399. The hope is that the medicine will help reduce the amount of mucus blocking the airways. By clearing these plugs, the treatment aims to help people breathe more easily, protect the delicate lung tissue from damage, and prevent exhausting chest infections.

To see if the drug works, doctors will take high-resolution CT scans of the lungs to count and measure mucus plugs before treatment begins and again at 24 weeks. They will also measure how much air participants can blow out in simple breathing tests, and track how often chest infections occur over a full year (52 weeks). This will help doctors understand whether the medicine provides real, lasting benefits compared to standard care.

Key takeaways

Tests a new medicine (SAR445399) to clear lung mucus plugs in adults with bronchiectasis.
Specifically for people whose bronchiectasis is not caused by cystic fibrosis.
Lasts for approximately 52 weeks (one year) with regular clinic visits and tests.
Uses detailed chest CT scans and breathing checks to measure improvements.
Participation is completely voluntary and you can leave at any point.

Who may be eligible?

This trial is open to adults aged 18 and older who have a confirmed medical diagnosis of bronchiectasis that is not caused by cystic fibrosis. Both men and women may be eligible to take part.

Because the study is specifically designed for non-cystic fibrosis bronchiectasis, anyone whose condition is linked to cystic fibrosis cannot join. The trial team will also look at your general health to ensure your heart, liver, and kidneys are working well enough for you to safely test a new medicine.

Before taking part, the research doctors will carry out routine health checks and go through your medical history. They will check which regular inhalers or medicines you use to confirm that the trial treatment is safe and suitable alongside your normal daily care.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have a confirmed diagnosis of bronchiectasis.
My bronchiectasis is not caused by cystic fibrosis.
I am willing to attend regular hospital check-ups and have chest scans.
I am happy to take either the active study drug or a dummy pill/treatment (placebo).

Answer every question to see your result.

What does participation involve?

Taking part in this study lasts for up to 52 weeks (one year). During the trial, you will be placed by chance into one of two groups: one group receives the study medicine (SAR445399) and the other receives a placebo, which looks identical but has no active drug. You will have regular appointments at a hospital clinic so doctors can monitor your health closely.

Visits will include special chest scans (CT scans) at the beginning and after 24 weeks to look at the mucus in your lungs. You will also do standard breathing tests (blowing into a tube), have your blood and urine checked, and have heart traces (ECGs) done. The study team will ask you to keep track of any chest symptoms or flare-ups. You will receive close medical support throughout the entire study.

Potential risks and benefits

Taking part may help clear mucus from your lungs and reduce chest infections, but there is no guarantee of direct benefit, particularly if you are in the placebo group. You may also experience side effects from the study drug, or temporary discomfort from tests like blood draws. However, your health and safety will be checked very frequently by lung specialists. Joining is entirely your choice, and you are free to stop and leave the study at any time without your regular NHS care being affected.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Spain
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Unverified
France
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Unverified
Netherlands
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Unverified
Germany

Common questions

What is a placebo and why is it used?

A placebo is a dummy treatment designed to look identical to the study medicine, but with no active ingredients. It helps researchers prove whether any improvements or side effects are truly caused by the study drug.

Will I know if I am getting the trial medicine or the placebo?

No. The trial is 'double-blind', meaning neither you nor your doctor will know which treatment you are taking. This prevents bias and ensures the study results are fair.

What happens if I get a chest infection during the study?

You must tell the study team straight away. They will record the infection as part of the study data and ensure you receive the proper medical treatment, such as antibiotics, to help you recover.

Do I have to pay to take part?

No. The study medicine, medical scans, and all trial tests are provided free of charge. Many trials also help cover reasonable travel expenses to and from clinic visits.

Can I continue taking my regular chest medicines?

In most cases, yes. The study team will carefully review your current medicines before you join to make sure they are safe to use alongside the study treatment.