Phase 2
N=151
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
Cystic Fibrosis (CF)
Bottom Line
View on ClinicalTrials.gov: NCT00677365 ↗Enrolled (actual)
151
Serious AEs
8.6%
Results posted
Jun 2012
Primary outcome: Primary: Change in P. Aeruginosa Density — 0.23; -0.31; -0.31; -0.73 log10 CFU/g sputum — p=0.0014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MP-376 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in P. Aeruginosa Density |
0.23; -0.31; -0.31; -0.73 | 0.0014 sig |
| SECONDARY Time to Administration of Other Anti-pseudomonal Antimicrobials |
31; NA; 56; 59 | 0.0007 sig |
| SECONDARY Percent Change in Forced Expiratory Volume in 1 Second (FEV1) |
-2.36; 1.93; 2.56; 6.25 | 0.0026 sig |
| SECONDARY Change in FEV1 Percent Predicted |
-2.39; 1.96; 3.10; 8.55 | 0.0008 sig |
| SECONDARY Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R) |
-0.44; 2.00; 0.31; 4.06 | 0.2174 |
| SECONDARY Changes in Susceptability Patterns of Isolated Organisms |
4; 4; 4; 4; 4; 4 | — |
Summary
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.
Eligibility Criteria
Inclusion Criteria (selected):
- > 16 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa within the past 18 months
- Patients are able to elicit a forced expiratory volume in 1 second (FEV1) >/= 25% but /= 3 x upper limit of normal (ULN) at Screening
Data sourced from ClinicalTrials.gov (NCT00677365). 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.