Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1)

Publication date: Available online 18 August 2019Source: Pulmonary Pharmacology & TherapeuticsAuthor(s): Michael R. Loebinger, Eva Polverino, Francesco Blasi, Stuart J. Elborn, James D. Chalmers, Harm AWM. Tiddens, Herman Goossens, Michael Tunney, Wenchun Zhou, Gerhild Angyalosi, Adam T. Hill, Charles S. Haworth, iBEST-1 Trial TeamAbstractIn patients with bronchiectasis (BE), infection with Pseudomonas aeruginosa (Pa) results in disease progression, frequent pulmonary exacerbations and lung function decline. However, at present, no inhaled antibiotics have been approved for the treatment of these patients. Tobramycin inhalation powder (TIP), approved for treatment of Pa infection in cystic fibrosis, could be a promising candidate.We aimed to assess effective and well-tolerated doses and regimens of TIP in BE patients with Pa infection.In this phase II, double-blind, placebo-controlled, randomised study, three different daily doses of TIP are administered either as continuous or cyclical regimens. The study protocol comprises 7–28 days of screening, 112 days of double-blind treatment and 56 days of follow-up. The plan was to enrol 180 patients (aged ≥18 years) with BE, documented Pa infection and a history of exacerbations. The primary outcome is change in sputum Pa density from baseline. Key secondary outcomes include number of pulmonary exacerbations, use of antipseudomonal antibiotics, serum and sputum tobramycin concentrations, quality of life and safety. Exploratory e...
Source: Pulmonary Pharmacology and Therapeutics - Category: Respiratory Medicine Source Type: research