Inhaled dry powder alginate oligosaccharide in cystic fibrosis: a randomised, double-blind, placebo-controlled, crossover phase 2b study
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Inhaled dry powder alginate oligosaccharide in cystic fibrosis : a randomised, double-blind, placebo-controlled, crossover phase 2b study. / 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.
I: ERJ Open Research, Bind 6, Nr. 4, 00132-2020, 2020.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - Inhaled dry powder alginate oligosaccharide in cystic fibrosis
T2 - a randomised, double-blind, placebo-controlled, crossover phase 2b study
AU - van Koningsbruggen-Rietschel, Silke
AU - Davies, Jane C
AU - Pressler, Tacjana
AU - Fischer, Rainald
AU - MacGregor, Gordon
AU - Donaldson, Scott H
AU - Smerud, Knut
AU - Meland, Nils
AU - Mortensen, Jann
AU - Fosbøl, Marie Ø
AU - Downey, Damian G
AU - Myrset, Astrid H
AU - Flaten, Hugo
AU - Rye, Philip D
N1 - Copyright ©ERS 2020.
PY - 2020
Y1 - 2020
N2 - 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.
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.
U2 - 10.1183/23120541.00132-2020
DO - 10.1183/23120541.00132-2020
M3 - Journal article
C2 - 33123558
VL - 6
JO - ERJ Open Research
JF - ERJ Open Research
SN - 2312-0541
IS - 4
M1 - 00132-2020
ER -
ID: 261542370