A phase II cross-over study of OligoG in subjects with cystic fibrosis

• Research type

  Research Study

• Full title

  A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa

• IRAS ID

  65591

• Contact name

  Martin Walshaw

• Contact email

  martin.walshaw@lhch.nhs.uk

• Sponsor organisation

  AlgiPharma AS

• Eudract number

  2010-023090-19

• ISRCTN Number

  N/A

• Research summary

  This study aims to examine the safety and local tolerability of an inhaled drug known as OligoG, and a preliminary exploration of whether it is effective for breaking up the structure of mucus in the lungs and airways and making infections more susceptible to treatment with antibiotics. Twenty-four subjects 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 cross-over study so the subjects will have 2 discrete treatment periods of 28 days separated by a 4 week ‘washout’ period. The subjects will receive OligoG in one of their treatment periods and placebo in the other. To facilitate nonbiased 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 study will have two sequential dosing cohorts. The first six subjects will be enrolled in Cohort 1, and admitted to the clinic for a 3-day period to closely monitor subject safety and tolerability before the remaining subjects are exposed to study medication. The dose volume will be increased step wise until 4.5 ml twice daily is reached on Day 3. This dose volume will subsequently be used on an outpatient basis until Day 28. Eighteen subjects will be enrolled into Cohort 2 after all Cohort 1 subjects have completed all evaluations through Day 4 and the Safety Review Team has reviewed available safety data and confirmed enrolment may continue as planned. Cohort 2 will undergo all study evaluations on an outpatient basis. The study will take place in 3 different sites and will last approximately 15 months from screening of patients, to the last patient completing the study.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  10/H1005/88

• Date of REC Opinion

  14 Jan 2011

• REC opinion

  Further Information Favourable Opinion