VITAL-BE Value of inhaled treatment with Aztreonam in bronchiectasis
A Trial of the Safety, Tolerability and Efficacy of 2 doses of Cayston (Aztreonam Lysine) compared to placebo in participants with bronchiectasis.
University of Dundee
Duration of Study in the UK
2 years, 0 months, 1 days
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 Pseuodomonas aeruginosa and other chronic Gram-negative infections. The presence of P. aeruginosa infection is associated with a higher frequency of acute exacerbations, worse quality of life and a three fold increase in mortality.There is a strong rationale for the effectiveness of inhaled antibiotic treatment in bronchiectasis. This trial will examine the safety, efficacy and tolerability of Aztreonam lysine an inhaled antibiotic licensed for use in cystic fibrosis. 100 participants with bronchiectasis and positive sputum culture for a gram negative infection will be randomised to one of four groups: 75mg Aztreonam three times per day, 75mg Aztreonam twice per day or matching placebo two or three times per day. Treatment will continue for 12 months on a month on month off regimen as per usual clinical practice for the use of Aztreonam. The main objectives of the trial are 1) to determine if treatment with Aztreonam lysine for inhalation will be safe and well tolerated as compared to placebo and 2) To determine if Aztreonam lysine for inhalation will result in a significant reduction in the frequency of exacerbations, time to first pulmonary exacerbation and additional clinical benefits in participants with bronchiectasis and a history of frequent exacerbations.
East of Scotland Research Ethics Service REC 2
Date of REC Opinion
7 Jan 2019
Further Information Favourable Opinion