Clinical trial NCT03229252: An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Spyryx Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2017-07-25
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis
* ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%
* Stable CF Lung Disease
* Males and non-pregnant, non-lactating females

Exclusion Criteria:

* Significant unstable co-morbidities within 28 days of screening
* Has received an investigational drug within 28 days of screening

Primary outcomes:
measure: Change in Percent Predicted FEV1
timeFrame: Baseline and Day 28
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Day 1 through Day 28
measure: Change From Baseline Through Day 28 in Clinical Laboratory Tests
timeFrame: Day 1 through Day 28
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary Heritage Medical Research Center
state: Alberta
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
state: Ontario
city: Toronto
country: Canada
facility: Saint Michael's Hospital
state: Ontario
city: Roscoff
country: France
facility: Centre Hospitalier Universitaire Brest
state: Bretagne
city: Rouen
country: France
facility: CHU de Rouen
state: Haute-Normandie
city: Montpellier
country: France
facility: CHU de Montpellier
state: Languedoc-Roussillon
city: Angers
country: France
facility: CHU de Angers
state: Pays De La Loire
city: Nice
country: France
facility: Hopital Pasteur
state: Provence Alpes Cote D'azur
city: Pierre Bénite
country: France
facility: Hospices Civils de Lyon (HCL)
state: Rhone-Alpes
city: Paris
country: France
facility: Assistance Publique-Hôpitaux de Paris Hôpital Cochin
city: Genoa
country: Italy
facility: Istituto Giannina Gaslini Ospedale Pediatrico
city: Lisbon
country: Portugal
facility: Hospital de Santa Maria
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Bristol
country: United Kingdom
facility: University Hospitals Bristol NHS Foundation Trust
city: Edinburgh
country: United Kingdom
facility: Western General Hospital - NHS Lothian
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
city: Liverpool
country: United Kingdom
facility: Liverpool Heart and Chest Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust Saint Bartholomews Hospital
city: London
country: United Kingdom
facility: Royal Brompton and Harefield NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester NHS Foundation Trust
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
References: