Phase 2
Completed N=91
An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
Source: ClinicalTrials.gov NCT03229252 ↗Enrolled (actual)
91
Serious AEs
4.4%
Results posted
Dec 2019
Primary outcomePrimary: Change in Percent Predicted FEV1 — 1.633; 0.800; 0.890 change from baseline in ppFEV1
Summary
28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
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 | — |
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. Informational only — not medical advice.