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HOPE-1

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

Participating Centres
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, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)

Evaluation of potential mucus clearing treatment for all patients with CF regardless of mutation

Trial Reference Number

99066

Trial type

Medication

Intervention
the name of the treatment or therapy being researched

Placebo Inhalation Solution,SPX-101

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

80

Last edited date

02 October 2017

CF sponsor

Spyryx Biosciences, Inc.

CF sponsor type

Commercial

Who can take part?

Age

18+

Top inclusion criteria
  • Stable CF Lung Disease
Top exclusion criteria
  • Significant unstable co-morbidities within 28 days of screening
  • Has received an investigational drug within 28 days of screening

CF centres running this trial

Recruiting

Belfast Health and Social Care Trust

Address

Belfast Health and Social Care Trust Trust Headquarters A Floor Belfast City Hospital Lisburn Road Belfast BT9 7AB

Recruitment starts

October 2017

Recruitment ends

March 2019

Contact

Downey, Damian

Get in touch

Recruiting

Heart of England NHS Foundation Trust

Address

Birmingham Heartlands Hospital Bordesley Green East Birmingham West Midlands B9 5SS

Recruitment starts

October 2017

Recruitment ends

February 2019

Contact

Nash, Edward

Get in touch

Recruiting

Queen Elizabeth University Hospital

Address

1345 Govan Road G51 4TF

Recruitment starts

January 2019

Recruitment ends

April 2019

Contact

MacGregor, Gordon

Get in touch

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

September 2017

Recruitment ends

March 2019

Contact

Simmonds, Nicholas

Get in touch
Show all participating centres