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®