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

December 6, 2019 updated by: Spyryx Biosciences, Inc.

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary Heritage Medical Research Center
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa
      • Toronto, Ontario, Canada, M5B1W8
        • Saint Michael's Hospital
  • France
      • Paris, France
        • Assistance Publique-Hôpitaux de Paris Hôpital Cochin
    • Bretagne
      • Roscoff, Bretagne, France
        • Centre Hospitalier Universitaire Brest
    • Haute-Normandie
      • Rouen, Haute-Normandie, France
        • CHU de Rouen
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France
        • CHU de Montpellier
    • Pays De La Loire
      • Angers, Pays De La Loire, France
        • CHU de Angers
    • Provence Alpes Cote D'azur
      • Nice, Provence Alpes Cote D'azur, France
        • Hôpital Pasteur
    • Rhone-Alpes
      • Pierre Bénite, Rhone-Alpes, France
        • Hospices Civils de Lyon (HCL)
  • Italy
      • Genoa, Italy
        • Istituto Giannina Gaslini Ospedale Pediatrico
  • Portugal
      • Lisbon, Portugal
        • Hospital de Santa Maria
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast Health and Social Care Trust
      • Birmingham, United Kingdom
        • Heart of England Nhs Foundation Trust
      • Bristol, United Kingdom
        • University Hospitals Bristol NHS Foundation Trust
      • Edinburgh, United Kingdom
        • Western General Hospital - NHS Lothian
      • Exeter, United Kingdom
        • Royal Devon and Exeter NHS Foundation Trust
      • Glasgow, United Kingdom
        • NHS Greater Glasgow and Clyde
      • Leeds, United Kingdom
        • The Leeds Teaching Hospitals Nhs Trust
      • Liverpool, United Kingdom
        • Liverpool Heart and Chest Hospital NHS Foundation Trust
      • London, United Kingdom
        • Barts Health NHS Trust Saint Bartholomews Hospital
      • London, United Kingdom
        • Royal Brompton and Harefield NHS Foundation Trust
      • Manchester, United Kingdom
        • University Hospital of South Manchester NHS Foundation Trust
      • Newcastle-upon-Tyne, United Kingdom
        • Newcastle Upon Tyne Hospitals
      • Nottingham, United Kingdom
        • Nottingham University Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Percent Predicted FEV1
Time Frame: Baseline and Day 28
Baseline and Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: Day 1 through Day 28
Day 1 through Day 28
Change From Baseline Through Day 28 in Clinical Laboratory Tests
Time Frame: Day 1 through Day 28
Chemistry, Hematology, Urinalysis
Day 1 through Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spyryx Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

June 20, 2019

Study Completion (Actual)

June 20, 2019

Study Registration Dates

First Submitted

July 14, 2017

First Submitted That Met QC Criteria

July 24, 2017

First Posted (Actual)

July 25, 2017

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 6, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPX-101-CF-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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