Cystic Fibrosis Clinical Trial
— (HOPE-1)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)
| Verified date | December 2019 |
| Source | Spyryx Biosciences, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | June 20, 2019 |
| Est. primary completion date | June 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | 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 |
| France | CHU de Angers | Angers | Pays De La Loire |
| France | CHU de Montpellier | Montpellier | Languedoc-Roussillon |
| France | Hopital Pasteur | Nice | Provence Alpes Cote D'azur |
| France | Assistance Publique-Hôpitaux de Paris Hôpital Cochin | Paris | |
| France | Hospices Civils de Lyon (HCL) | Pierre Bénite | Rhone-Alpes |
| France | Centre Hospitalier Universitaire Brest | Roscoff | Bretagne |
| France | CHU de Rouen | Rouen | Haute-Normandie |
| Italy | Istituto Giannina Gaslini Ospedale Pediatrico | Genoa | |
| Portugal | Hospital de Santa Maria | Lisbon | |
| United Kingdom | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Spyryx Biosciences, Inc. |
Canada, France, Italy, Portugal, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Percent Predicted FEV1 | Baseline and Day 28 | ||
| Secondary | Number of Participants With Adverse Events | Day 1 through Day 28 | ||
| Secondary | Change From Baseline Through Day 28 in Clinical Laboratory Tests | Chemistry, Hematology, Urinalysis | Day 1 through Day 28 |
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