PT  - JOURNAL ARTICLE
AU  - Silke van Koningsbruggen-Rietschel
AU  - Jane C. Davies
AU  - Tacjana Pressler
AU  - Rainald Fischer
AU  - Gordon MacGregor
AU  - Scott H. Donaldson
AU  - Knut Smerud
AU  - Nils Meland
AU  - Jann Mortensen
AU  - Marie Ø. Fosbøl
AU  - Damian G. Downey
AU  - Astrid H. Myrset
AU  - Hugo Flaten
AU  - Philip D. Rye
ED  - ,
TI  - Inhaled dry powder alginate oligosaccharide in cystic fibrosis: a randomised, double-blind, placebo-controlled, crossover phase 2b study
AID  - 10.1183/23120541.00132-2020
DP  - 2020 Oct 01
TA  - ERJ Open Research
PG  - 00132-2020
VI  - 6
IP  - 4
4099  - http://openres.ersjournals.com/content/6/4/00132-2020.short
4100  - http://openres.ersjournals.com/content/6/4/00132-2020.full
SO  - erjor2020 Oct 01; 6
AB  - Background OligoG is a low molecular-weight alginate oligosaccharide that improves the viscoelastic properties of cystic fibrosis (CF) mucus and disrupts biofilms, thereby potentiating the activity of antimicrobial agents. The efficacy of inhaled OligoG was evaluated in adult patients with CF.Methods A randomised, double-blind, placebo-controlled multicentre crossover study was used to demonstrate safety and efficacy of inhaled dry powder OligoG. Subjects were randomly allocated to receive OligoG 1050 mg per day (10 capsules three times daily) or matching placebo for 28 days, with 28-day washout periods following each treatment period. The primary end-point was absolute change in percentage predicted forced expiratory volume in 1 s (FEV1) at the end of 28-day treatment. The intention-to-treat (ITT) population (n=65) was defined as randomised to treatment with at least one administration of study medication and post-dosing evaluation.Results In this study, 90 adult subjects were screened and 65 were randomised. Statistically significant improvement in FEV1 was not observed in the ITT population. Adverse events included nasopharyngitis, cough and pulmonary exacerbation. The number and proportions of patients with adverse events and serious adverse events were similar between OligoG and placebo group.Conclusions Inhalation of OligoG-dry powder over 28 days was safe in adult CF subjects. Statistically significant improvement of FEV1 was not reached. The planned analyses did not indicate a significant treatment benefit with OligoG compared to placebo. Post hoc exploratory analyses showed subgroup results that indicate that further studies of OligoG in this patient population are justified.Inhalation of OligoG-DPI over 28 days was shown to be safe in adult CF subjects. Statistically significant improvement of FEV1 was not reached. Post hoc subgroup analyses support mechanism of action for OligoG and warrant further prospective studies. https://bit.ly/2PHq6Z0