Completed Lungs & Breathing NIHR-supported project Digestion, Kidneys & Other Organs

A randomised, double-blind, placebo-controlled study to investigate the safety, tolerability, and pharmacokinetics of inhaled CHF6333 after single ascending doses in healthy volunteers and one single dose in adult subjects with bronchiectasis, followed...

In plain English

AI plain-English summary

Healthy volunteers and people with bronchiectasis will inhale single doses of an experimental drug called CHF6333 to test whether it is safe and tolerable. The study then extends to giving two doses over a longer period to people with bronchiectasis. This matters because bronchiectasis is a chronic lung condition in which the airways become permanently widened, trapping mucus and making the lungs prone to repeated infections. These infections trigger exacerbations—sudden worsening of symptoms like coughing, sputum production, fatigue, and breathlessness—that can lead to hospitalisation and permanent lung damage. Currently, treatments focus on clearing mucus and managing infections, but no drug directly targets the underlying inflammation that drives exacerbations. CHF6333 is designed to reduce this inflammation. If the drug proves safe and shows signs of activity, it could lead to a new class of inhaled anti-inflammatory treatments for bronchiectasis. That would give patients a way to prevent exacerbations rather than just treating them after they occur, potentially reducing hospital admissions, slowing lung decline, and improving quality of life. The study also provides early data on how the drug behaves in the body, which is essential for planning larger trials.

View original technical description
A clinical study in which different single doses of a study drug (CHF6333) and placebo are administrated in healthy subjects and a single dose of the same drug and placebo is administrated in subjects with bronchiectasis with a specific inhaler to evaluate if the study drug is safe, well tolerated and to check some parameters related to its activity. After this part, 2 doses of the study drug and placebo will be administrated for a longer period to subjects with bronchiectasis. Bronchiectasis is a long-term condition where the airways of the lungs become widened, leading retention of mucus that can make the lungs more vulnerable to infection. The most common symptoms of bronchiectasis include: a persistent cough usually associated with sputum production, fatigue and a shortness of breath. The severity of symptoms can vary widely from patient to patient and, if an infection appears in the patients’ lung, it can worsen the symptoms and lead to episodes called exacerbations.

Researchers

Michael Loebinger (Principal Investigator)

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