Spyryx Hope-1 Study

Principal Investigator: 

Dr Damian Downey

 

Name of the Study:

Spyryx Hope-1: 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

         

Why is this Study important?: 

The Study is designed to evaluate the efficacy and safety of SPX-101 inhalation solution, administered in different dose regimens, in a 28-day treatment period in approximately 80 adults with CF. SPX-101 is an inhaled peptide that keeps the airways hydrated and therefore makes mucous clearance easier.

 

What is the Research question/aim?: 

To evaluate the efficacy of SPX-101 in subjects with cystic fibrosis (CF).

 

What the Study involves: 

Duration of the treatment: 28 days:

Visit 1 (Screening) (5 hrs) Spirometer and ECG

Visit 2 (Day 1) (7 hrs) Spirometer and ECG

Visit 3 (Day 7) (3 hrs) Spirometer

Visit 4 (Day 14) (3 hrs) Spirometer and ECG

Visit 5 (Day 28) (3 hrs) Spirometer and ECG

 

PPI Involvement: 

Not applicable.

 

Who can take part in the Study?:

Male or non-pregnant female subjects, aged 18 – 50 years inclusive, with a diagnosis of cystic fibrosis.

 

Contact Information:

Dr Damian Downey

Respiratory Research Office

Belfast City Hospital

Lisburn Road

Belfast

BT9 7AB

Email: Damian.downey@belfasttrust.hscni.net

Phone: 028 950 41136

Location:

NI Clinical Research Facility,

U Floor, Belfast City Hospital,

Lisburn Road, Belfast, BT9 7AB

 

Tel:+44 (0)28 9504 0342

Email:NICRF@belfastrust.hscni.net

 
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