Overview

Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis

Status:
Completed
Trial end date:
2019-09-01
Target enrollment:
0
Participant gender:
Male
Summary
This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV anti-pseudomonals.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborator:
University of Liverpool
Treatments:
Aztreonam
Colistin
Criteria
Inclusion Criteria:

1. Confirmed diagnosis of CF

2. Patients aged 18 - 65 years of age who can give informed consent

3. FEV1 >25% or <75% predicted (in keeping with Cayston® license)

4. Admitted to the Liverpool Heart & Chest Hospital with an exacerbation of CF pulmonary
disease

5. Presence of PA in lower respiratory tract cultures in the 6 months prior

Exclusion Criteria:

1. Documented allergy to beta-lactam antibiotics or IV Colistin

2. Growth of Burkholderia Cepacia Complex (BCC) within 2 years

3. Pregnancy

4. Previous organ transplant

5. Receiving other clinical trial medication

6. Already prescribed regular Cayston®