An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
NCT ID: NCT03229252
Last Updated: 2019-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
91 participants
INTERVENTIONAL
2017-08-01
2019-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo Inhalation solution twice daily for 28 days.
Placebo Inhalation Solution
Normal Saline Inhalation Solution
SPX-101 Low Dose
Inhalation solution twice daily for 28 days.
SPX-101
SPX-101 Inhalation Solution
SPX-101 High Dose
Inhalation solution twice daily for 28 days.
SPX-101
SPX-101 Inhalation Solution
Interventions
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Placebo Inhalation Solution
Normal Saline Inhalation Solution
SPX-101
SPX-101 Inhalation Solution
Eligibility Criteria
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Inclusion Criteria
* ppFEV1 (percent predicted FEV1) between 50.0% and 80.0%
* Stable CF Lung Disease
* Males and non-pregnant, non-lactating females
Exclusion Criteria
* Has received an investigational drug within 28 days of screening
18 Years
50 Years
ALL
No
Sponsors
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Spyryx Biosciences, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Calgary Heritage Medical Research Center
Calgary, Alberta, Canada
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
Ottawa, Ontario, Canada
Saint Michael's Hospital
Toronto, Ontario, 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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SPX-101-CF-201
Identifier Type: -
Identifier Source: org_study_id