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
Email:NICRF@belfastrust.hscni.net
