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A dose finding study of OligoG in patients with CF

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)

The study will be a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose finding study in patients with cystic fibrosis. The trial is divided into two parts, with part 1 designed to identify the best dose, while part 2 is designed to assess the efficacy, safety and tolerability of the inhaled alginate oligosaccharide OligoG compared to placebo after 26 weeks of treatment, followed by a 26 weeks open label extension. Randomised patients will receive daily administrations of OligoG or placebo, both administered in addition to standard of care for 26 weeks. All patients will be offered OligoG in an open label study extension of an additional 26 weeks.

Trial Reference Number

106614

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Oligo G Dry powder for inhalation

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

180

Last edited date

19 February 2018

CF sponsor

AlgiPharma

CF sponsor type

Commercial

Who can take part?

Top inclusion criteria
  • 12 Years and older.
  • History of PA infection in last 12 months.
  • Concomitant inhaled tobramycin, colistin, aztreonam, or leviflaxin (cycled or continuous).
Top exclusion criteria
  • History of comorbidity that may distort results or cause additional risk.
  • pulmonary exacerbation within 28 days prior to randomisation
  • Use of hypertonic saline > twice daily