A Phase II randomized study of OligoG in subjects with cystic fibrosis
Research type
Research Study
Full title
A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosachharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis
IRAS ID
156574
Contact name
Martin John Walshaw
Contact email
Sponsor organisation
AlgiPharma AS
Eudract number
2014-000844-13
Research summary
This study aims to examine the efficacy of an inhaled drug known as OligoG in it's new formulation. OligoG has previously been tested in a nebulised solution and will be tested as a dry powder inhalation in this study.
A total of seventy-six patients aged 18 years and over with cystic fibrosis, caused by a single faulty gene that controls the movement of salt in the body, would be eligible for this study. It is a crossover study so the patients will have 2 discrete treatment periods of 28 days separated by a 4 week “washout” period. The patients will receive OligoG in one of their treatment periods and placebo in the other.To facilitate non-biased observations, this is a "blinded" study; neither the patients nor the clinical staff will know patients’ randomized treatment assignments (active OligoG or placebo), in the respective periods.
The first twelve patients will be treated in a dose escalation fashion. The dose will be increased step wise until 10 capsules three times a day is reached on Day 2. This dose will subsequently be used until Day 28. The remaining sixty-four patients will be treated with 10 capsules three times a day for the full 28 days of treatment.The study will take place across three different countries; with four sites currently identified in the UK. The study will last approximately 15 months from screening of patients, to the last patient completing the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
14/NE/1041
Date of REC Opinion
5 Aug 2014
REC opinion
Further Information Favourable Opinion