Phase 3
N=330
MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT01180634 ↗Enrolled (actual)
330
Serious AEs
9.7%
Results posted
Apr 2024
Primary outcome: Primary: Time to an Exacerbation — 58; 51.5 Days — p=0.0715
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aeroquin (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to an Exacerbation |
58; 51.5 | 0.0715 |
| SECONDARY Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1) |
0.08; 1.49 | 0.0213 sig |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa Sputum Density |
0.04; -0.59 | 0.0002 sig |
| SECONDARY Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R) |
4.66; 4.94 | 0.8335 |
| SECONDARY Relative Change From Baseline in Percent Predicted FEV1 |
1.24; 3.66 | 0.0122 sig |
| SECONDARY Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials |
59; 55 | 0.3000 |
| SECONDARY Time to First Hospitalization |
NA; NA | 0.8670 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events |
214; 108 | — |
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. Decreased efficacy, intolerance and high treatment burden with currently available therapies indicate a need for additional therapies. MP-376 (Aeroquin™) is a novel formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery. Preclinical and clinical studies conducted to date show that aerosol doses of MP-376 are safe and well tolerated, exert an antimicrobial effect, improve lung function and reduce the need for other anti-pseudomonal antibiotics. High concentrations of levofloxacin in the lung delivered as MP-376 are active against CF pathogens including those with high minimum inhibitory concentration (MIC) levels to aminoglycosides such as tobramycin (TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered rapidly and efficiently using a customized PARI investigational configuration of the eFlow® nebulizer system.
Eligibility Criteria
Inclusion Criteria (selected):
- >/= 12 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa at screening and within the past 12 months
- Patients are able to elicit an FEV1 >/= 25% but </= 85% of predicted value at screening
- Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
- Clinically stable with no changes in health status within the last 28 days
- Able to reproducibly produce sputum and perform spirometry
Exclusion Criteria (selected):
- Use of any nebulized or systemic antibiotics within 28 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Evidence of respiratory infections within 14 days prior to dosing
- CrCl < 20ml/min or < 20ml/min/1.73 m2 at Screening
Data sourced from ClinicalTrials.gov (NCT01180634). 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.