A dose finding study of OligoG in patients with Cystic Fibrosis

Details

Therapeutic category
Anti-Infective
Trial status
Project in Setup
Phase
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
Anti-infective agent
Recruitment target
180
Last edited date
19/02/2018
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

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