Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung MedDRA version: 9.1 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa
Conditions
Interventions
Product Name: MP-376
Product Code: MP-376
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: levofloxacin
CAS Number: 100986-85-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentrat
Sponsors
Mpex Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Are at least 16 years of age (at least 18 years of age in Germany and the Netherlands). 2. Have a clinical diagnosis of CF based on the following criteria: a) positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or b) a genotype with two identifiable mutations consistent with CF, and c) accompanied by one or more clinical features consistent with the CF phenotype. 3. Are able to elicit an FEV1 > 25% but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have used an investigational agent within 30 days prior to Visit 1. 2. Have used any nebulized or systemic antibiotics active against P. aeruginosa within 30 days prior to Visit 1, other than maintenance oral azithromycin, which must be have been initiated at least 30 days prior to Visit 1. 3. History of hypersensitivity to fluoroquinolones or excipients of MP-376 (magnesium chloride). 4. History of intolerance to bronchodilators or unwilling to use a bronchodilator during the study. 5. Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day. 6. Changes in physiotherapy technique or schedule within 14 days prior to Visit 1. 7. Changes in medical regimen for treatment of CF (e.g., introduction, dose escalation, or elimination of therapies such as dornase alfa, non-steroidal anti-inflammatory agents, azithromycin, hypertonic saline, or inhaled corticosteroids) within 30 days of Visit 1. 8. History of lung transplantation 9. Evidence of acute upper respiratory tract infection within 10 days or lower respiratory tract infection within 30 days prior to Visit 1 10. Are pregnant, breastfeeding, or unwilling to practice birth control or abstinence during participation in the study (women only). 11. Have a history of seizures or low seizure threshold (e.g., epilepsy). 12. Have renal dysfunction (calculated CrCl 15% relative decline in FEV1 (L) from Screening to Visit 1. 18. Are a dependent (as an employee or relative) of the sponsor, contract research organization or Investigator. 19. Have a present condition, or abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of three dosage regimens of MP-376 administered over 28 days, compared to placebo ;Secondary Objective: To evaluate the safety and tolerability of three dosage regimens of MP-376 administered over 28 days, compared to placebo To evaluate the pharmacokinetic/pharmacodynamic (PK/PD) relationships for levofloxacin with MP-376 administration;Primary end point(s): Primary Endpoint Change in P. aeruginosa density (log10 colony-forming units [CFU] per gram sputum) from Visit 1 to Visit 4 Secondary Endpoints Clinical • Changes in respiratory and other domains of CFQ-R from Visit 1 to Visit 4 •Time to administration of IV/oral/inhaled anti-pseudomonal antimicrobials in patients with at least one of the following: - Decreased exercise tolerance - Increased cough - Increased sputum/chest congestion - Decreased appetite Microbiology • Change in P. aeruginosa density (log10 colony-forming units [CFU] per gram sputum) from Visit 1 to all subsequent scheduled study visits at which sputum for microbiology is collected (Study Visits 2, 3, 4, and Final/Early Term). • Changes in bacterial load of all organisms from Visit 1 to all subsequent scheduled study visits at which sputum for microbiology is collected (Study Visits 2, 3, 4 and Final Visit) • Changes in susceptibility patterns of isolated organisms from Visit 1 to all subsequent scheduled study visits at which sputum microbiology is collected (Study Visits 2, 3, 4 and Final Visit) Pulmonary Function • Mean percent change in FEV1, FVC, and FEF 25-75 from Visit 1 to all subsequent scheduled study visits at which PFTs are collected (Study Visits 3, 4 and Final Visit). Pharmacokinetic Evaluation • Population and Bayesian estimates of levofloxacin (e.g. AUC, Cmax, Cmin) Safety • Assessment of adverse events and drug intolerability from Visit 1 through end of study between treatment groups will be evaluated. • Changes from Visit 1 in physical examination findings, pulse oximetry result | — |
Countries
Germany, Netherlands
Outcome results
None listed