Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4)
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4)
IRAS ID
149131
Contact name
Diana Bilton
Contact email
Sponsor organisation
Aradigm Corporation
Eudract number
2013-005366-19
Clinicaltrials.gov Identifier
N/A
Research summary
Non-cystic fibrosis(non-CF) bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation and destruction.The origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response are typical of the disease.It has been reported that long-term systemic antibiotic treatment results in significant improvements in respiratory symptoms, pulmonary exacerbations, and health related QoL in patients with severe bronchiectasis.However, antibiotics frequently fail to eradicate lung infections despite intensive therapy.In addition, relapse may occur when the antibiotics are stopped, and resistance frequently occurs with long-term use of systemic antibiotics. An attractive alternative is the use of an inhaled antibiotic that delivers drug in high concentrations directly to the site of infection, eliminating the need for high systemic concentrations and reducing the risk of systemic toxicity or gastrointestinal side effects. Ciprofloxacin is a well established and extensively utilized broad spectrum fluoroquinolone antibiotic that is indicated for oral and intravenous treatment of lower respiratory tract infections including P. aeruginosa. However, after inhalation of pure ciprofloxacin, the drug residence time in the lung is too short to provide additional therapeutic benefit over drug administered by oral or intravenous routes. An inhaled liposome encapsulated formulation of ciprofloxacin could provide improved biopharmaceutical characteristics that would address the issue of short drug residence time in the lung. Potential advantages of the liposome-encapsulated ciprofloxacin over pure ciprofloxacin include altered drug pharmacokinetics (PK) and biodistribution, sustained drug release from the carrier, enhanced delivery to disease sites, and protection of the active drug species from rapid elimination through pulmonary absorption. Approximately 255 subjects will be enrolled in a 2:1 ratio to Pulmaquin (170 subjects) and placebo (85 subjects). This study will consist of an up to 30 day Screening Phase, a Double Blind Phase including six 56 day treatment cycles. Each treatment cycle will consist of 28 days of study drug treatment (On treatment Period) followed by 28 days of no study drug treatment (Off treatment Period). The total duration of the Double Blind Phase of the study will be 337 days including 48 weeks (336 days) of treatment cycles and an End of Double Blind Phase Visit at Day 337.
REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0471
Date of REC Opinion
15 Apr 2014
REC opinion
Favourable Opinion