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

This study is currently recruiting participants.
Verified November 2017 by Spyryx Biosciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03229252
First Posted: July 25, 2017
Last Update Posted: November 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.
  Purpose
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

Condition Intervention Phase
Cystic Fibrosis Drug: Placebo Inhalation Solution Drug: SPX-101 Phase 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Spyryx Biosciences, Inc.:

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

Secondary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 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


Estimated Enrollment: 78
Actual Study Start Date: August 1, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 40.0% and 70.0%
  • 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
  Contacts and Locations
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


Contacts
Contact: Alistair Wheeler, MD 919-899-9399 contact@spyryxbio.com

Locations
Canada, Alberta
University of Calgary Heritage Medical Research Center Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Michael Parkins, MD         
Canada, Ontario
Ottawa Hospital Research Institute/Institut de Recherche de l'Hospital d'Ottawa Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Shawn Aaron, MD         
Saint Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Elizabeth Tullis, MD         
France
Centre Hospitalier Universitaire Brest Not yet recruiting
Roscoff, Bretagne, France
Contact: Sophie Ramel, MD         
CHU de Rouen Not yet recruiting
Rouen, Haute-Normandie, France
Contact: Stéphane Dominique, MD         
CHU de Montpellier Recruiting
Montpellier, Languedoc-Roussillon, France
Contact: Raphaël Chiron, MD         
CHU de Angers Recruiting
Angers, Pays De La Loire, France
Contact: Christine Person-Tacnet, MD         
Hopital Pasteur Not yet recruiting
Nice, Provence Alpes Cote D'azur, France
Contact: Sylvie Leroy, MD         
Hospices Civils de Lyon (HCL) Recruiting
Pierre Bénite, Rhone-Alpes, France
Contact: Isabelle Durieu, MD         
Assistance Publique-Hôpitaux de Paris Hôpital Cochin Not yet recruiting
Paris, France
Contact: Isabelle Fajac, MD         
Portugal
Hospital de Santa Maria Recruiting
Lisbon, Portugal
Contact: Pilar Azevedo, MD         
United Kingdom
Belfast Health and Social Care Trust Recruiting
Belfast, United Kingdom
Contact: Damian Downey, MD         
Heart of England NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Contact: Edward Nash, MD         
Western General Hospital Not yet recruiting
Edinburgh, United Kingdom
Contact: Alastair Innes, MD         
Royal Devon and Exeter NHS Foundation Trust Recruiting
Exeter, United Kingdom
Contact: Nicholas Withers, MD         
The Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom
Contact: Daniel Peckham, MD         
Liverpool Heart and Chest Hospital NHS Foundation Trust Recruiting
Liverpool, United Kingdom
Contact: Martin Ledson, MD         
Royal Brompton and Harefield NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Nicholas Simmonds         
University Hospital of South Manchester NHS Foundation Trust Recruiting
Manchester, United Kingdom
Contact: Andrew Jones, MD         
Newcastle Upon Tyne Hospitals Recruiting
Newcastle-upon-Tyne, United Kingdom
Contact: Simon Doe, MD         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Helen Barr, MD         
Sponsors and Collaborators
Spyryx Biosciences, Inc.
  More Information

Responsible Party: Spyryx Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03229252     History of Changes
Other Study ID Numbers: SPX-101-CF-201
First Submitted: July 14, 2017
First Posted: July 25, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pharmaceutical Solutions