The purpose of the study is to assess the efficacy of Alginate oligosaccharide (OligoG) dry powder for inhalation in cystic fibrosis (CF) patients with a Burkholderia spp. infection.
Primary objective: To explore the efficacy of inhaled OligoG in reducing the microbial burden of Burkholderia spp. as measured in expectorated sputum samples. Secondary objectives: To explore the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures. To evaluate the safety, tolerability and subject compliance with treatment The study will also evaluate the effect of inhaled OligoG on various efficacy variables such as lung function, Quality-of-Life, rheology and other microbiological outcome measures, and evaluate the safety and patient compliance with treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15
Inhalation of dry powder for inhalation (DPI)
Pneumologische Praxis Pasing
Münich, Münich-Pasing, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
Changes in Burkholderia spp. density in expectorated sputum and/or induced sputum.
Time frame: 28 days, i.e. at start and end of treatment
Clinical safety as measured by vital signs
Measurement of vital signs
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112
Clinical safety as measured by ECG
Measurement of ECG
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112
Clinical safety as measured by blood oxygen saturation
Measurement of blood oxygen saturation
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow upat day 112
Clinical safety as measured by FEV1 (Forced Expiratory Volume in 1 second)
Measurement of pulmonary function tests
Time frame: Time Frame: Screening, day 0, 14, 28, 56, 70, 84 and follow up at day 112
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