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
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Sponsor:
Spyryx Biosciences, Inc.
Information provided by (Responsible Party):
Spyryx Biosciences, Inc.
Tracking Information | |||||
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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 |
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 |
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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 |
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Condition ICMJE | Cystic Fibrosis | ||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
90 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement |
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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 |