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Inhaled Aztreonam Lysine treatment for bronchiectasis

A Trial of the Safety, Tolerability and Efficacy of 2 Doses of Cayston (Aztreonam Lysine) Compared to Placebo in Participants With Bronchiectasis

Phase 2 Interventional University of Dundee · NCT03696290

This study is testing if inhaled Aztreonam Lysine can help adults with bronchiectasis who often have lung flare-ups by seeing if it can delay these flare-ups compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment77 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity of Dundee Academic / other
Locations14 sites (Torquay, Devon and 13 other locations)
Trial IDNCT03696290 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and effectiveness of inhaled Aztreonam Lysine compared to a placebo in adults with bronchiectasis. It is a multi-centre, randomized, double-blind, placebo-controlled trial designed to assess whether 12 months of treatment can significantly increase the time to the first pulmonary exacerbation in participants with a history of frequent exacerbations. The study focuses on individuals with chronic Pseudomonas aeruginosa infections, aiming to reduce neutrophilic inflammation and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of bronchiectasis and a history of at least three exacerbations in the past year.

Not a fit: Patients with cystic fibrosis or those with active tuberculosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with bronchiectasis, potentially reducing the frequency of exacerbations and improving quality of life.

How similar studies have performed: Previous studies of inhaled antibiotics in bronchiectasis have shown mixed results, indicating that while some approaches have been promising, the effectiveness of inhaled Aztreonam Lysine specifically remains to be fully established.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* ≥ 18 years of age
* Able to give informed consent
* Clinical diagnosis of Bronchiectasis
* CT scan of the chest demonstrating bronchiectasis in 1 or more lobes
* A history of at least 3 exacerbations in the previous 12 months
* Bronchiectasis severity index score \>4
* Pseudomonas aeruginosa or other Gram-negative respiratory pathogen detected in sputum or bronchoalveolar lavage on at least 1 occasion in the previous 12 months.
* A sputum sample that is culture positive for P. aeruginosa or other Gram-negative respiratory pathogens sent at the screening visit and within 28 days of randomization. Pre-specified eligible organisms include Eschericia coli, Haemophilus influenzae, Moraxella catarrhalis, Klebsiella pneumoniae, Proteus mirabilis, Serratia marcescens, Achromobacter, Enterobacter and Stenotrophomonas maltophilia

Exclusion Criteria:

* Participant has cystic fibrosis
* Immunodeficiency requiring replacement immunoglobulin.
* Active tuberculosis or nontuberculous mycobacterial infection (defined as currently under treatment, or requiring treatment in the opinion of the investigator).
* Recent significant haemoptysis (a volume requiring clinical intervention, within the previous 4 weeks).
* Treatment with inhaled, systemic or nebulized anti-Pseudomonal antibiotics in the 28 days prior to randomization
* Oral macrolides which have been taken for a period of less than 3 months prior to the start of the trial.
* Treatment of an exacerbation and receiving antibiotic treatment within 4 weeks of randomization
* Primary diagnosis of COPD associated with \>20 pack years smoking history.
* History of poorly controlled asthma or a history of bronchospasm with inhaled antibiotics.
* Pregnant or lactating females.
* Participants with FEV1 \<30% predicted value at screening.
* Previous history of intolerance to Aztreonam or bronchospasm reported with any other inhaled anti-bacterial.
* Glomerular filtration rate (eGFR) below 30ml/min/1.73m2 or requiring dialysis. This will be determined at screening.
* Use of any investigational drugs within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer.
* Unstable co-morbidities (cardiovascular disease, active malignancy) which in the opinion of the investigator would make participation in the trial not in the participants best interest.
* Long term oxygen therapy
* Women of child bearing age or male partners of women of child bearing age and not practicing a method of acceptable birth control (see below)

Where this trial is running

Torquay, Devon and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Bronchiectasis AdultBronchiectasis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.