MPEX-209 Study; Version 2.0 dated 8th November 2010

• Research type

  Research Study

• Full title

  A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients.

• IRAS ID

  74308

• Sponsor organisation

  Mpex Pharmaceuticals, Inc.

• Eudract number

  2010-019634-26

• Clinicaltrials.gov Identifier

  NCT01270347

• Research summary

  This study is a Phase 3, multi-center, randomised, open-label, parallel group study to evaluate the comparative safety of MP-376 (Aeroquin?½) and Tobramycin Inhalation Solution (TIS) in stable Cystic Fibrosis (CF) patients with chronic P. aeruginosa lung infection. MP-376 (Aeroquin?½) is a new, investigational, inhaled formulation of a licensed drug called levofloxacin. Levofloxacin is a broad spectrum antibiotic that kills many different types of bacteria and is approved, in oral and injection form, by the European Regulatory Agency for the treatment of serious infections.Efficacy data for MP-376 and TIS at the end of the first 28-day treatment period will be compared, as well as explored, over multiple treatment cycles. Patients will be enrolled in this study in a 2:1 ratio, to receive MP-376 240 mg twice daily or TIS 300 mg twice daily. MP-376 will be administered using a PARIinvestigational eFlow© nebuliser. TIS will be administered using a PARI LC© Plus nebuliser with compressor, or via another approved nebuliser/compressor compatible with country-specific labelling. Approximately 330 patients will be screened to enrol approximately 267 patients, assuming a 20% screen failure rate. Patients will be enrolled in this study at approximately 100 US and non-US sites. Following a 14-day screening period, patients will be randomised at Visit 1/Day 1to receive either MP-376 or TIS. Patients will receive 28 days of MP-376 or TIS alternating with 28-day periods of no inhaled antimicrobial treatment, for a total time of six 28-day periods. Patients should remain off anti-pseudomonal antimicrobials, other than MP-376 or TIS, and azithromycin (if they are receiving it), for the duration of the study unless they meet the protocol defined definition of an exacerbation or unless anti-pseudomonal antimicrobials are deemed necessary for safety reasons by the Investigator. The end of the study is defined as the last visit of the last patient.

• REC name

  HSC REC B

• REC reference

  11/NI/0050

• Date of REC Opinion

  18 Aug 2011

• REC opinion

  Further Information Favourable Opinion