An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis ((HOPE-1))
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03229252 |
Recruitment Status :
Completed
First Posted : July 25, 2017
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cystic Fibrosis | Drug: Placebo Inhalation Solution Drug: SPX-101 | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo Inhalation solution twice daily for 28 days.
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Drug: Placebo Inhalation Solution
Normal Saline Inhalation Solution |
Experimental: SPX-101 Low Dose
Inhalation solution twice daily for 28 days.
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Drug: SPX-101
SPX-101 Inhalation Solution |
Experimental: SPX-101 High Dose
Inhalation solution twice daily for 28 days.
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Drug: SPX-101
SPX-101 Inhalation Solution |
- Change in Percent Predicted FEV1 [ Time Frame: Baseline and Day 28 ]
- 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

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 |
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

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

Documents provided by Spyryx Biosciences, Inc.:
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |