Inhaled dry powder alginate oligosaccharide in cystic fibrosis: a randomised, double-blind, placebo-controlled, crossover phase 2b study. Issue 4 (19th October 2020)

• Record Type: Journal Article
• Authors: van Koningsbruggen-Rietschel, Silke; Davies, Jane C.; Pressler, Tacjana; Fischer, Rainald; MacGregor, Gordon; Donaldson, Scott H.; Smerud, Knut; Meland, Nils; Mortensen, Jann; Fosbøl, Marie Ø.; Downey, Damian G.; Myrset, Astrid H.; Flaten, Hugo; Rye, Philip D.
• Other Names: author non-byline.; Carroll Mary author non-byline.; Davies Jane author non-byline.; Schwarz Carsten author non-byline.; Derichs Nico author non-byline.; Downey Damian author non-byline.; Eickmeier Olaf author non-byline.; Finstad Pal Leyell author non-byline.; Øbro Fossbøl Marie author non-byline.; Gilljam Marita author non-byline.; Hjelte Lena author non-byline.; Knox Alan author non-byline.; van Koningsbruggen-Rietschel Silke author non-byline.; MacGregor Gordon author non-byline.; Mortensen Jann author non-byline.; Nährig Susanne author non-byline.; Pressler Tacjana author non-byline.; Riethmüller Joachim author non-byline.; Ringshausen Felix C. author non-byline.; Flaten Hugo author non-byline.; AlgiPharma AS author non-byline.; Gow Laura author non-byline.; Conway Joy author non-byline.; Mortensen Jann author non-byline.; Donaldson Scott H. author non-byline.; Bennett William author non-byline.
• Is Part Of: ERJ open research. Volume 6:Issue 4(2020)
• Publication Date: 2020-10-19
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiration -- Periodicals; Respiration; Respiratory organs -- Diseases; Respiratory organs -- Diseases -- Treatment; Respiratory Tract Diseases; Electronic journals; Fulltext; Internet Resources; Periodicals; Periodical; 616.2005
• DOI: 10.1183/23120541.00132-2020
• Languages: English
• ISSNs: 2312-0541

Abstract

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