AZTEC-CF
Research type
Research Study
Full title
Aztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy.
IRAS ID
206907
Contact name
Freddy Frost
Contact email
Sponsor organisation
Liverpool Heart & Chest Hospital
Eudract number
2016-002832-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Cystic fibrosis (CF) is an inherited condition that affects multiple systems in the body, in particular the lungs where it is characterised by thick mucous secretions, recurrent chest infections and progressive decline in lung function. Individuals with CF suffer repeated chest infections that often require an admission to hospital to be treated with two antibiotics via a drip. Repeated courses of antibiotics via drip can cause side-effects and damage to other organs. This study aims to investigate whether it is safe and effective to use one inhaled antibiotic and one via a drip, instead of the current standard of practice of two antibiotics via a drip. Participants will receive the two different treatments the next two occasions they need to be admitted to Liverpool Heart & Chest Hospital with a chest infection. On one admission they will receive two IV antibiotics, on the other admission they will receive one IV antibiotic and inhaled aztreonam (known as Cayston®). The order they receive each treatment will be picked at random. Participants will have measurements taken including lung function tests, blood tests, CF quality of life questionnaires and sputum samples will be sent to the University of Liverpool for advanced analysis of the effect each treatment has on bugs in the lung. It is hoped that this study may help provide more information toward a much needed expansion of therapeutic options available in CF.
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0741
Date of REC Opinion
11 Nov 2016
REC opinion
Further Information Favourable Opinion