Phase 2
N=91
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT03229252 ↗Enrolled (actual)
91
Serious AEs
4.4%
Results posted
Dec 2019
Primary outcome: Primary: Change in Percent Predicted FEV1 — 1.633; 0.800; 0.890 change from baseline in ppFEV1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo Inhalation Solution (Drug); SPX-101 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spyryx Biosciences, Inc.
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percent Predicted FEV1 |
1.633; 0.800; 0.890 | — |
| SECONDARY Number of Participants With Adverse Events |
20; 11; 30 | — |
| SECONDARY Change From Baseline Through Day 28 in Clinical Laboratory Tests |
0; 0; 0; 29; 13; 40 | — |
Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03229252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.