Imperial College London
Alternate

ProfessorDianaBilton

Faculty of Medicine, National Heart & Lung Institute

Honorary Clinical Senior Lecturer
 
 
 
//

Contact

 

+44 (0)7801 067 057diana.bilton

 
 
//

Location

 

Fulham RoadRoyal Brompton Campus

//

Summary

 

Publications

Citation

BibTex format

@article{Haworth:2019:10.1016/s2213-2600(18)30427-2,
author = {Haworth, CS and Bilton, D and Chalmers, JD and Davis, AM and Froehlich, J and Gonda, I and Thompson, B and Wanner, A and O'Donnell, AE},
doi = {10.1016/s2213-2600(18)30427-2},
journal = {The Lancet. Respiratory medicine},
pages = {213--226},
title = {Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials.},
url = {http://dx.doi.org/10.1016/s2213-2600(18)30427-2},
volume = {7},
year = {2019}
}
Download

RIS format (EndNote, RefMan)

TY  - JOUR
AB  - <h4>Background</h4>In patients with non-cystic fibrosis bronchiectasis, lung infection with Pseudomonas aeruginosa is associated with frequent pulmonary exacerbations and admission to hospital for treatment, reduced quality of life, and increased mortality. Although inhaled antibiotics are conditionally recommended for long-term management of non-cystic fibrosis bronchiectasis with frequent exacerbations, there is no approved therapy. We investigated the safety and efficacy of inhaled liposomal ciprofloxacin (ARD-3150) in two phase 3 trials.<h4>Methods</h4>ORBIT-3 and ORBIT-4 were international, randomised, double-blind, placebo-controlled, phase 3 trials run concurrently in similar geographical regions. Eligible patients had non-cystic fibrosis bronchiectasis, had had at least two pulmonary exacerbations treated with antibiotics in the previous 12 months, and had a history of chronic P aeruginosa lung infection. Patients were randomly assigned (2:1) to receive either ARD-3150 or placebo. ARD-3150 (3 mL liposome encapsulated ciprofloxacin 135 mg and 3 mL free ciprofloxacin 54 mg) or 6 mL placebo (3 mL dilute empty liposomes mixed with 3 mL of saline) was self-administered once daily for six 56-day treatment cycles, for 48 weeks. The primary endpoint was time to first pulmonary exacerbation from the date of randomisation to week 48. We did primary and secondary efficacy, safety, and microbiology analyses on the full analysis population, which comprised all randomised patients who received at least one dose of study drug. ORBIT-3 and ORBIT-4 are registered with ClinicalTrials.gov, numbers NCT01515007 and NCT02104245, respectively.<h4>Findings</h4>Between March 31, 2014, and Aug 19, 2015, we screened 514 patients in ORBIT-3 and 533 patients in ORBIT-4. The full analysis populations consisted of 278 patients in ORBIT-3 (183 patients received at least one dose of ARD-3150 and 95 received placebo) and 304 patients in ORBIT-4 (206 patien
AU  - Haworth,CS
AU  - Bilton,D
AU  - Chalmers,JD
AU  - Davis,AM
AU  - Froehlich,J
AU  - Gonda,I
AU  - Thompson,B
AU  - Wanner,A
AU  - O'Donnell,AE
DO  - 10.1016/s2213-2600(18)30427-2
EP  - 226
PY  - 2019///
SN  - 2213-2600
SP  - 213
TI  - Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): two phase 3, randomised controlled trials.
T2  - The Lancet. Respiratory medicine
UR  - http://dx.doi.org/10.1016/s2213-2600(18)30427-2
VL  - 7
ER  -
Download