Objectives
The objectives of the iABC project are:
- To determine the initial therapeutic efficacy of TIP in BE patients
- To explore novel endpoints (microbiome, LCI and CT imaging) for clinical trials in both CF and BE
- To build repositories of clinical respiratory isolates and sputum biobanks for use in future research
- To develop an EU-wide prospective registry of BE in all EU and EU-associated countries to facilitate better clinical care and future research into this disease
- To develop an inhaled formulation and dispersion device for POL7080, a novel antibiotic with activity against Pseudomonas aeruginosa.
- To determine the pharmacokinetics and safety of POL7080 in CF patients and provide efficacy data.
- To evaluate the safety and tolerability of the OSCN- and LF compounds of ALX-009, separately and combined at different doses.
- To evaluate the clinical efficacy of different doses and different administration schedules of ALX-009 and the contribution of each of its compounds (OSCN/LF) when administered separately in CF patients in order to define an optimal treatment regimen.
- To determine the therapeutic efficacy of QBW251 (a CFTR potentiator) in patients with BE