An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
(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 (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)
1 other identifier
interventional
91
5 countries
25
Brief Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2017
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2017
CompletedFirst Posted
Study publicly available on registry
July 25, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedResults Posted
Study results publicly available
December 30, 2019
CompletedDecember 30, 2019
December 1, 2019
1.9 years
July 14, 2017
August 26, 2019
December 6, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Percent Predicted FEV1
Baseline and Day 28
Secondary Outcomes (2)
Number of Participants With Adverse Events
Day 1 through Day 28
Change From Baseline Through Day 28 in Clinical Laboratory Tests
Day 1 through Day 28
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo Inhalation solution twice daily for 28 days.
SPX-101 Low Dose
EXPERIMENTALInhalation solution twice daily for 28 days.
SPX-101 High Dose
EXPERIMENTALInhalation solution twice daily for 28 days.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Significant unstable co-morbidities within 28 days of screening
- Has received an investigational drug within 28 days of screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
University of Calgary Heritage Medical Research Center
Calgary, Alberta, T2N 1N4, Canada
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
Ottawa, Ontario, K1H 8L6, Canada
Saint Michael's Hospital
Toronto, Ontario, M5B1W8, Canada
Hospices Civils de Lyon (HCL)
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire Brest
Roscoff, Brittany Region, France
CHU de Rouen
Rouen, Haute-Normandie, France
CHU de Montpellier
Montpellier, Languedoc-Roussillon, France
CHU de Angers
Angers, Pays de la Loire Region, France
Hopital Pasteur
Nice, Provence-Alpes-Côte d'Azur Region, France
Assistance Publique-Hôpitaux de Paris Hôpital Cochin
Paris, France
Istituto Giannina Gaslini Ospedale Pediatrico
Genoa, Italy
Hospital de Santa Maria
Lisbon, Portugal
Belfast Health and Social Care Trust
Belfast, United Kingdom
Heart of England NHS Foundation Trust
Birmingham, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Western General Hospital - NHS Lothian
Edinburgh, United Kingdom
Royal Devon and Exeter NHS Foundation Trust
Exeter, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom
The Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust Saint Bartholomews Hospital
London, United Kingdom
Royal Brompton and Harefield NHS Foundation Trust
London, United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, United Kingdom
Newcastle Upon Tyne Hospitals
Newcastle upon Tyne, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
No Limitations or Caveats
Results Point of Contact
- Title
- Dr. Rob Tarran
- Organization
- Spyryx Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2017
First Posted
July 25, 2017
Study Start
August 1, 2017
Primary Completion
June 20, 2019
Study Completion
June 20, 2019
Last Updated
December 30, 2019
Results First Posted
December 30, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share