HNEi Phase I/IIa
Research type
Research Study
Full title
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 by a placebo controlled, repeated-dose, 3-way cross-over in adult subjects with bronchiectasis
IRAS ID
1008057
Contact name
Roberta Macchia
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Research summary
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.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0163
Date of REC Opinion
19 Oct 2023
REC opinion
Further Information Favourable Opinion