A dose finding study of OligoG in patients with Cystic Fibrosis
Research type
Research Study
Full title
A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).
IRAS ID
243252
Contact name
Jane Davies
Contact email
Sponsor organisation
Algipharma AS
Eudract number
2018-000378-30
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
This is a multi-National (UK, Ireland, Germany, Austria, Australia and New Zealand), multi-centre (53 sites), randomised, double blind, dose finding study of inhaled alginate oligosaccharide (OligoG) versus placebo in patients with Cystic Fibrosis (age ≥12 years).
OligoG is expected to work directly on mucus in the lung and airways, making it easier to remove the mucus naturally from the body and making bacteria in the lungs easier to treat with antibiotics.
There are currently no treatments available to cure Cystic fibrosis (CF). Established therapies mainly focus on treating the CF symptoms; many of them come with side effects or require time-consuming hospitalisations. The need for alternative or additional treatments to prolong life expectancy by improving the lung function of the CF patients is evident. Previous studies with OligoG have already shown that administration can be carried out easily by patients in their own home, and observed side effects have been very limited.
A total of 180 eligible patients will be included in this study, 120 patients will be included in Part 1 of the study (dose finding) and up to 60 patients will be included in part 2 of the study (selected dose of OligoG from Part 1).
Part 1 of the study will consist of a 4 treatment arm (3 doses of OligoG and placebo), randomised, double blind, placebo controlled dose finding study (with 30 patients per treatment arm) treated for 12 weeks with either OligoG or placebo.
Part 2 of the study will consist of a two arm (selected dose of OligoG from part 1 and placebo) randomised, double blind, placebo controlled study (up to 30 patients per treatment arm) treated for 26 weeks with OligoG or placebo. After the 26 weeks treatment all patients will be offered open label treatment with OligoG for a further 26 weeks.REC name
London - Central Research Ethics Committee
REC reference
19/LO/1313
Date of REC Opinion
18 Oct 2019
REC opinion
Further Information Favourable Opinion