The purpose of the study is assessment of efficacy and safety of OligoG as a dry powder formulation, in adult subjects with cystic fibrosis.
The primary objective is to demonstrate efficacy of inhaled OligoG measured by FEV1, and supported by secondary endpoints including Mucociliary Clearance, rheology,microbiology and Quality-of-Life. The secondary objectives are 1. To demonstrate the safety and tolerability of inhaled OligoG as a dry powder for inhalation after multiple dose administration; and 2. To evaluate patient compliance with treatment. The design will be randomized, double-blind, placebo-controlled, multi-center, cross-over phase II study. Mucociliary and Cough clearance (MCC) will be an exploratory endpoint in a subset of 24 patients, and Lung Clearance Index (LCI) an exploratory endpoint in another subset of 20 or more patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
65
Inhalation
Rigshospitalet
Copenhagen, Denmark
Pediatric Pulmonology and Immunology, Charité Universitätsmedizin
Berlin, Germany
FEV1 (Forced Expiratory Volume in 1 second)
An improvement in FEV1 during treatment with OligoG as compared to placebo is the primary endpoint of the study.
Time frame: 28 days, i.e. start and end of treatment periods
Mucociliary and cough clearance
Mucociliary clearance is assessed by measuring the movement of an inhaled radiotracer up the airways.
Time frame: 28 days, i.e. start and end of treatment periods
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CF Zentrum Köln, Universitätskrankenhaus Köln
Cologne, Germany
Medizinische Klinik I, Pneumologie, Uniklinik
Frankfurt, Germany
Klinik für Pneumologie, CF-Ambulanz
Hanover, Germany
Mukoviszidose-Zentrum für Erwachsene, Med. Klinik V-Innenstadt (LMU)
Münich, Germany
Pneumologische Praxis Pasing
Münich, Germany
Center for Pediatric Clinical Studies,
Tübingen, Germany
Oslo University Hospital
Oslo, Norway
CF-mottagningen, Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
...and 8 more locations