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HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness

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, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis 

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

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

31 days

Intervention
The name of the treatment or therapy being researched

Placebo Inhalation Solution,SPX-101

Last edited date

02 October 2017

Sponsor

Spyryx Biosciences, Inc.

Sponsor type

Commercial

Who can take part?

Age

18+

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

CF centres running this trial

Recruiting

Heart of England NHS Foundation Trust

Address

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

Recruitment ends

February 2019

Contact

Nash, Edward

Get in touch

Recruiting

Leeds Teaching Hospitals NHS Trust

Address

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

Recruitment ends

November 2018

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

September 2017

Recruitment ends

November 2018

Contact

Helen Barr,

Get in touch

Recruiting

Royal Brompton and Harefield NHS Foundation Trust

Address

Royal Brompton Hospital Sydney Street London Greater London SW3 6NP

Recruitment starts

October 2017

Recruitment ends

November 2018

Contact

Simmonds, Nick

Get in touch
Show all participating centres