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An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis ((HOPE-1))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03229252
Recruitment Status : Active, not recruiting
First Posted : July 25, 2017
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.

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

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: Placebo Inhalation Solution Drug: SPX-101 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-Blind
Primary Purpose: Treatment
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)
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo Inhalation solution twice daily for 28 days.
Drug: Placebo Inhalation Solution
Normal Saline Inhalation Solution

Experimental: SPX-101 Low Dose
Inhalation solution twice daily for 28 days.
Drug: SPX-101
SPX-101 Inhalation Solution

Experimental: SPX-101 High Dose
Inhalation solution twice daily for 28 days.
Drug: SPX-101
SPX-101 Inhalation Solution




Primary Outcome Measures :
  1. Change in percent predicted FEV1 [ Time Frame: Baseline and Day 28 ]

Secondary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: Day 1 through Day 28 ]
  2. Change from baseline through Day 28 in clinical laboratory tests [ Time Frame: Day 1 through Day 28 ]
    Chemistry, Hematology, Urinalysis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of CF
  • ppFEV1 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229252


Locations
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Canada, Alberta
University of Calgary Heritage Medical Research Center
Calgary, Alberta, Canada, T2N 1N4
Canada, Ontario
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
Ottawa, Ontario, Canada, K1H 8L6
Saint Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
France
Centre Hospitalier Universitaire Brest
Roscoff, Bretagne, France
CHU de Rouen
Rouen, Haute-Normandie, France
CHU de Montpellier
Montpellier, Languedoc-Roussillon, France
CHU de Angers
Angers, Pays De La Loire, France
Hopital Pasteur
Nice, Provence Alpes Cote D'azur, France
Hospices Civils de Lyon (HCL)
Pierre Bénite, Rhone-Alpes, France
Assistance Publique-Hôpitaux de Paris Hôpital Cochin
Paris, France
Italy
Istituto Giannina Gaslini Ospedale Pediatrico
Genoa, Italy
Portugal
Hospital de Santa Maria
Lisbon, Portugal
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, United Kingdom
Sponsors and Collaborators
Spyryx Biosciences, Inc.

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Responsible Party: Spyryx Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03229252     History of Changes
Other Study ID Numbers: SPX-101-CF-201
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions