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

Tracking Information
First Submitted Date ICMJE	July 14, 2017
First Posted Date ICMJE	July 25, 2017
Last Update Posted Date	October 23, 2018
Actual Study Start Date ICMJE	August 1, 2017
Estimated Primary Completion Date	April 1, 2019 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 24, 2017)	Change in percent predicted FEV1 [ Time Frame: Baseline and Day 28 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT03229252 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 24, 2017)	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
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Official Title ICMJE	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)
Brief Summary	28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Masking Description: Double-Blind Primary Purpose: Treatment
Condition ICMJE	Cystic Fibrosis
Intervention ICMJE	Drug: Placebo Inhalation Solution Normal Saline Inhalation Solution; Drug: SPX-101 SPX-101 Inhalation Solution
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Recruiting
Estimated Enrollment ICMJE; (submitted: July 16, 2018)	90
Original Estimated Enrollment ICMJE; (submitted: July 24, 2017)	78
Estimated Study Completion Date	April 1, 2019
Estimated Primary Completion Date	April 1, 2019 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact: Lynn Smiley, MD 919-899-9399 contact@spyryxbio.com
Listed Location Countries ICMJE	Canada, France, Italy, Portugal, United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT03229252
Other Study ID Numbers ICMJE	SPX-101-CF-201
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Spyryx Biosciences, Inc.
Study Sponsor ICMJE	Spyryx Biosciences, Inc.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Spyryx Biosciences, Inc.
Verification Date	October 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP