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A dose finding study of OligoG in patients with Cystic Fibrosis

Details

Therapeutic category
the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise

Anti-Infective

Trial status

Project in Setup

Phase
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use

Phase II

Full title

A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF).

OligoG is a small sugar molecule that comes from seaweed, harvested off the coast of Norway. Studies indicate that OligoG may make CF mucus less sticky, and it may also help antibiotics to combat infections. Although OligoG has been tested and found to be safe in about 130 CF patients, more research is needed to find the best dose and to study the effect of longer term use. OligoG is given as a dry powder for inhalation. Ten capsules are to be taken twice daily. During this study patients may take their other usual medications in addition to OligoG. Part 1 will be a three month long study to find the best of three different doses. Each patient will be given one of three different OligoG doses, or a placebo (placebo is a product that looks like the test medication, but it does not contain any OligoG). This means that 3 of 4 patients will receive active medication You will be asked to visit the clinic 7 times in Part 1.Part 2 is designed to assess the efficacy, safety and tolerability of the chosen dose of OligoG compared to placebo following 26 weeks of treatment. The patients will take OligoG or placebo twice daily for 26 weeks. Half of the patients will receive active drug. You will be asked to visit the clinic 10 times in Part 2. All patients participating in part 2 will be offered to continue with open label OligoG for an additional 26 weeks.

Trial Reference Number

106614

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Anti-infective agent

Recruitment target
the number of participants who need to be recruited for the trial in the UK

180

Last edited date

26 November 2019

CF sponsor

AlgiPharma

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older.
  • History of Pseudomonas Aeruginosa infection in the last 12 months
  • Currently using inhaled tobramycin, colistin, aztreonam, or leviflaxin for 3 months (cycled or continuous) at screening
Top exclusion criteria
  • Pulmonary exacerbation within 28 days prior to enroling in the study
  • Use of hypertonic saline more than twice daily
  • History of allergic reactions to the ingredients of the IMP incl. lactose and milk protein