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A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations

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

Mucociliary Clearance

Trial status

Open to recruitment

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 Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung Disease

This study investigates the use of cysteamine in the treatment of adults with Cystic Fibrosis who are experiencing an exacerbation of CF-associated lung disease. There are six different potential dosing regimens, including one that is placebo.

Trial type

Medication

Length of participation
The length of time a participant will take part in a trial, from the first to the last appointment

3 weeks

Intervention
The name of the treatment or therapy being researched

Cysteamine or Placebo

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

120

Last edited date

22 August 2017

Sponsor

Novabotics

Sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • CF-associated lung disease with documented history of chronic infection with Gram-negative organism(s)
  • FEV1 >30% of predicted within the 6 months prior to study exacerbation
  • At the baseline visit: experiencing a new exacerbation of CF-associated lung disease (based on Investigator assessment of ≥4 symptoms present on the Fuchs' criteria) requiring treatment that includes an aminoglycoside antibiotic.
Top exclusion criteria
  • Hypersensitive to cysteamine or to any of the excipients
  • Hypersensitive to penicillamine
  • Transplant recipient

CF centres running this trial

Closed

Aberdeen

Address

Foresterhill, Aberdeen AB25 2ZN

Recruitment ends

November 2017

Contact

,

Get in touch

Closed

Aberdeen Royal Infirmary

Address

Foresterhill, Aberdeen AB25 2ZN

Recruitment starts

December 2016

Recruitment ends

November 2017

Contact

Devereux, Graham

Get in touch

Closed

Queen Elizabeth University Hospital

Address

1345 Govan Road G51 4TF

Recruitment starts

December 2016

Recruitment ends

November 2017

Contact

MacGregor, Gordon

Get in touch

Closed

Royal Victoria Infirmary

Address

Queen Victoria Road Newcastle upon Tyne NE1 4LP

Recruitment starts

December 2016

Recruitment ends

November 2017

Contact

Doe, Simon

Get in touch
Show all participating centres