Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis (AZTEC-CF)
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ClinicalTrials.gov Identifier: NCT02894684 |
Recruitment Status :
Completed
First Posted : September 9, 2016
Last Update Posted : October 7, 2019
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Condition or disease | Intervention/treatment | Phase |
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Cystic Fibrosis Infection Pseudomonas | Drug: Aztreonam Drug: Standard Care | Phase 4 |
AZLI, marketed as Cayston, is an inhaled beta-lactam antibiotic. It has a license for the chronic suppression of Pseudomonas aeruginosa (PA). Current standard practice dictates the use of two IV antipseudomonal antibiotics for the treatment of acute pulmonary exacerbations. The increasing survival, and hence population, in CF means that newer antimicrobial strategies are required in order to manage antimicrobial resistance, minimise adverse systemic effects of heavy antimicrobial exposure and also make effective use of resources. Inhaled antibiotics are commonly used in the chronic suppression of PA yet their use has not been thoroughly investigated in acute pulmonary exacerbation. Inhaled antibiotics deliver their drugs directly to the target-site with minimal systemic absorbance, making them an attractive candidate for treatment of acute exacerbations.
Recently, it has become apparent that the bacterial community is much more complex than initially thought. The microbiome, a term used to describe the polymicrobial community in the lungs, has become apparent due to the use of modern culture-independent methods to detect bacteria. The microbiome changes in composition and structure around the time of exacerbations and in response to treatment, although these changes have not been prospectively characterised.
We have designed an open-label randomised, controlled cross-over trial to investigate the clinical effectiveness of of AZLI in the treatment of acute pulmonary exacerbation, whilst simultaneously comparing the effect inhaled and intravenous antibiotics have on the microbiome.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | February 2019 |
Actual Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
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Experimental: AZLI then Standard Care
Upon first exacerbation this arm will receive AZLI, on their second they will receive standard care
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Drug: Aztreonam
14 days of AZLI: 75mg TDS PLUS IV Colistin
Other Names:
Drug: Standard Care 14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin |
Active Comparator: Standard Care then AZLI
Upon first exacerbation this arm will receive standard care, on the second exacerbation this arm will receive AZLI
|
Drug: Aztreonam
14 days of AZLI: 75mg TDS PLUS IV Colistin
Other Names:
Drug: Standard Care 14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin |
- Average actual change in percent predicted forced expiratory volume at 1 second (FEV1) from Day 1 to Day 14 [ Time Frame: 14 days ]The actual change in FEV1 (%predicted) from Day 1 of admission to Day 7 & Day 14
- Time to first pulmonary exacerbation [ Time Frame: 12 months ]Time from discharge to next pulmonary exacerbation
- Average change from baseline in the Cystic Fibrosis Quality of Life Questionnaire (CFQ-R) [ Time Frame: 14 days ]Average change from baseline (Day 1) in the CFQ-R Respiratory Symptom Score (RSS) at the end (Day 14) of each arm of the study
- Microbiome changes [ Time Frame: 14 days ]Changes in the structure and composition of the microbiome at the beginning and end of each treatment arm
- PA sputum counts [ Time Frame: 14 days ]Changes in sputum PA counts from the beginning to end of each treatment arm.
- Antimicrobial resistance [ Time Frame: 14 days ]Prevalence of resistance to antibiotics at the beginning and end of each treatment arm.

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Ages Eligible for Study: | 16 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Confirmed diagnosis of CF
- Patients aged 18 - 65 years of age who can give informed consent
- FEV1 >25% or <75% predicted (in keeping with Cayston® license)
- Admitted to the Liverpool Heart & Chest Hospital with an exacerbation of CF pulmonary disease
- Presence of PA in lower respiratory tract cultures in the 6 months prior
Exclusion Criteria:
- Documented allergy to beta-lactam antibiotics or IV Colistin
- Growth of Burkholderia Cepacia Complex (BCC) within 2 years
- Pregnancy
- Previous organ transplant
- Receiving other clinical trial medication
- Already prescribed regular Cayston®

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02894684
United Kingdom | |
Liverpool Heart & Chest Hospital NHS Trust | |
Liverpool, United Kingdom, L3 9BZ |
Principal Investigator: | Freddy Frost, BMBS BMedSci | Liverpool Heart & Chest Hospital NHS Foundation Trust |
Responsible Party: | Liverpool Heart and Chest Hospital NHS Foundation Trust |
ClinicalTrials.gov Identifier: | NCT02894684 |
Other Study ID Numbers: |
2016AZLIND001 |
First Posted: | September 9, 2016 Key Record Dates |
Last Update Posted: | October 7, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases Lung Diseases |
Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Aztreonam Anti-Bacterial Agents Anti-Infective Agents |