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

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ClinicalTrials.gov Identifier: NCT03229252
Recruitment Status : Completed
First Posted : July 25, 2017
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.

Study Description
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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

Study Design
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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
Actual Primary Completion Date : June 20, 2019
Actual Study Completion Date : June 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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


Outcome Measures
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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


Eligibility Criteria
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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 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
Contacts and Locations
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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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Sponsors and Collaborators
Spyryx Biosciences, Inc.
  Study Documents (Full-Text)

Documents provided by Spyryx Biosciences, Inc.:
Study Protocol  [PDF] May 14, 2018
Statistical Analysis Plan  [PDF] July 9, 2019

More Information
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Responsible Party: Spyryx Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03229252    
Other Study ID Numbers: SPX-101-CF-201
First Posted: July 25, 2017    Key Record Dates
Results First Posted: December 30, 2019
Last Update Posted: December 30, 2019
Last Verified: December 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