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

Who is this study for? Adult patients with Bronchiectasis
What treatments are being studied? Aztreonam
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A randomised controlled trial of the safety, tolerability and effectiveness of Cayston Cayston (Aztreonam Lysine) compared to placebo in participants with bronchiectasis. Bronchiectasis not due to cystic fibrosis is a chronic inflammatory disease characterised by cough, sputum production and frequent respiratory tract infections. There are currently no licensed therapies for bronchiectasis approved by regulators in the United States or Europe. The disease has a high morbidity, particularly in the presence of chronic P. aeruginosa and other chronic Gram-negative infections. This trial will test the hypothesis that 12 months treatment with Aztreonam lysine for inhalation will be safe and well tolerated, and will result in a significant increase in the time to first pulmonary exacerbation in participants with bronchiectasis and a history of frequent exacerbations. This is a multi-centre randomised double-blind placebo controlled parallel group trial with four treatment arms. It will enroll 100 bronchiectasis patients with a history of at least 3 exacerbations in the previous year and the presence of chronic Gram-negative infection in sputum at screening. Patients will be treated following a one month on, one month off treatment regimen for 12 months. The primary objective is to evaluate the safety and tolerability of Aztrenam lysine in these patients by recording adverse events and trial treatment withdrawals.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
Other Locations
United Kingdom
Royal Papworth hospital NHS Foundation Trust
RECRUITING
Cambridge
Cardiff & Vale University Local Health Board
RECRUITING
Cardiff
University Hospitals of Derby and Burton NHS Foundation Trust
RECRUITING
Derby
NHS Tayside
RECRUITING
Dundee
NHS Lanakrshire University Hospital Hairmyres
RECRUITING
East Kilbride
The Princess Alexandra Hospital NHS Trust
RECRUITING
Harlow
Aintree University Hospital
RECRUITING
Liverpool
Liverpool Heart and Chest Hospital
RECRUITING
Liverpool
Royal Brompton & Harefield NHS Foundation Trust
RECRUITING
London
Manchester University NHS Foundation Trust - Wythenshawe Hospital
RECRUITING
Manchester
Freeman Hospital
RECRUITING
Newcastle Upon Tyne
University hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Torbay Hospital
RECRUITING
Torquay
NHS Lanarkshire: University Hospital Wishaw
RECRUITING
Wishaw
Contact Information
Primary
James Chalmers, MBChB, MRCP
j.chalmers@dundee.ac.uk
01382 386131
Backup
Fiona McLaren-Neil, MA
f.mclarenneil@dundee.ac.uk
01382 383830
Time Frame
Start Date: 2019-10-19
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 77
Treatments
Active_comparator: Aztreonam lysine, 3 doses per day
3 doses per day of nebulised Aztreonam lysine (75 mg) for 1 month, followed by 1 month off treatment. The month on, month off regimen will be repeated for a total peroid of 12 months.
Placebo_comparator: Placebo, 3 doses per day
3 doses per day of nebulised placebo (5 mg lactose monohydrate) for 1 month, followed by 1 month off treatment. The month on, month off regimen will be repeated for a total peroid of 12 months.
Active_comparator: Aztreonam lysine, 2 doses per day
2 doses per day of nebulised Aztreonam lysine (75 mg) for 1 month, followed by 1 month off treatment. The month on, month off regimen will be repeated for a total peroid of 12 months.
Placebo_comparator: Placebo, 2 doses per day
2 doses per day of nebulised placebo (5 mg lactose monohydrate) for 1 month, followed by 1 month off treatment. The month on, month off regimen will be repeated for a total peroid of 12 months.
Related Therapeutic Areas
Sponsors
Leads: University of Dundee
Collaborators: Gilead Sciences

This content was sourced from clinicaltrials.gov