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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 : Recruiting
First Posted : July 25, 2017
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.

July 14, 2017
July 25, 2017
October 23, 2018
August 1, 2017
April 1, 2019   (Final data collection date for primary outcome measure)
Change in percent predicted FEV1 [ Time Frame: Baseline and Day 28 ]
Same as current
Complete list of historical versions of study NCT03229252 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-Blind
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: Placebo Inhalation Solution
    Normal Saline Inhalation Solution
  • Drug: SPX-101
    SPX-101 Inhalation Solution
  • Placebo Comparator: Placebo
    Placebo Inhalation solution twice daily for 28 days.
    Intervention: Drug: Placebo Inhalation Solution
  • Experimental: SPX-101 Low Dose
    Inhalation solution twice daily for 28 days.
    Intervention: Drug: SPX-101
  • Experimental: SPX-101 High Dose
    Inhalation solution twice daily for 28 days.
    Intervention: Drug: SPX-101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
78
April 1, 2019
April 1, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact: Lynn Smiley, MD 919-899-9399 contact@spyryxbio.com
Canada,   France,   Italy,   Portugal,   United Kingdom
 
 
NCT03229252
SPX-101-CF-201
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Spyryx Biosciences, Inc.
Spyryx Biosciences, Inc.
Not Provided
Not Provided
Spyryx Biosciences, Inc.
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP