Value of inhaled treatment with Aztreonam lysine in bronchiectasis- VITAL- BE

Phase 1

• Conditions: Bronchiectasis; MedDRA version: 20.1Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001590-24-GB
• Lead Sponsor: niversity of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-24
• Last Update Posted: 8 June 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 35 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified