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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

Leeds Teaching Hospitals NHS Trust

Address

St. James's University Hospital Beckett Street Leeds West Yorkshire LS9 7TF

Recruitment starts

September 2017

Recruitment ends

January 2019

Contact

Peckham, Daniel

Get in touch

Recruiting

Nottingham University Hospitals NHS Trust

Address

Trust Headquarters City Hospital campus Hucknall Road Nottingham Nottinghamshire NG7 2UH

Recruitment starts

August 2017

Recruitment ends

January 2019

Contact

Barr, Helen

Get in touch

Recruiting

Royal Devon and Exeter NHS Foundation Trust

Address

Royal Devon and Exeter Hospital Barrack Road Exeter Devon EX2 5DW

Recruitment starts

September 2017

Recruitment ends

January 2019

Contact

Withers, Nick

Get in touch

Recruiting

University Hospital of South Manchester NHS Foundation Trust

Address

Wythenshawe Hospital Southmoor Road Wythenshawe Manchester Greater Manchester M23 9LT

Recruitment ends

January 2019

Contact

,

Get in touch
Show all participating centres