Value of Inhaled Treatment With Aztreonam Lysine in Bronchiectasis

Launched by UNIVERSITY OF DUNDEE · Oct 2, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a treatment called Aztreonam Lysine for adults with bronchiectasis, a long-term lung condition that causes coughing, mucus production, and frequent lung infections. The trial aims to find out if using Aztreonam Lysine for one year can help patients experience fewer flare-ups of their symptoms compared to a placebo (a treatment that does not contain the active drug). Participants will be selected if they are at least 18 years old, have been diagnosed with bronchiectasis, and have had at least three flare-ups in the past year due to specific types of bacteria in their lungs.

If you choose to participate, you will receive either the active treatment or a placebo for a total of 12 months, with a schedule of one month on treatment followed by one month off. Throughout the trial, your health will be monitored for any side effects or issues. This study is important because, currently, there are no approved medications for bronchiectasis in the U.S. or Europe, and it seeks to explore a potential new option for managing this challenging condition.

Gender

ALL

Eligibility 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)