Value of Inhaled Treatment With Aztreonam Lysine in Bronchiectasis
Status:
Active, not recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
A randomised controlled trial of the safety, tolerability and effectiveness of 2 doses of
Cayston (Aztreonam Lysine) compared to placebo in participants with bronchiectasis.
Bronchiectasis not due to cystic fibrosis is a chronic inflammatory disease characterised by
cough, sputum production and frequent respiratory tract infections. There are currently no
licensed therapies for bronchiectasis approved by regulators in the United States or Europe.
The disease has a high morbidity, particularly in the presence of chronic P. aeruginosa and
other chronic Gram-negative infections.
This trial will test the hypothesis that 12 months treatment with Aztreonam lysine for
inhalation will be safe and well tolerated, and will result in a significant increase in the
time to first pulmonary exacerbation in participants with bronchiectasis and a history of
frequent exacerbations.
This is a multi-centre randomised double-blind placebo controlled parallel group trial with
four treatment arms. It will enroll 100 bronchiectasis patients with a history of at least 3
exacerbations in the previous year and the presence of chronic Gram-negative infection in
sputum at screening. Patients will be treated following a one month on, one month off
treatment regimen for 12 months.
The primary objective is to evaluate the safety and tolerability of Aztrenam lysine in these
patients by recording adverse events and trial treatment withdrawals.