Clinical Trial: Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis

Brief Summary: This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last 8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1<80% predicted).

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome: To evaluate the serum pharmacokinetics (PK) of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 2x300mg/d Tobramycin Nebuliser Solution (=TNS) inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) subjects [ Time Frame: 8 wks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum PK of inhaled tobramycin (AUC 0-90') of continuous daily dosing regimens with 1 x 300mg/d tobramycin nebulized solution (= TNS) inhaled with the PARI eFlow rapid in cystic fibrosis subjects. [ Time Frame: 8 wks ]
  • Compare serum PK of inhaled tobramycin (trough-/peak-level)of both dosing regimens in CF-subjects with a FEV1≥80% vs. CF-Subjects with a FEV1<80%. [ Time Frame: 8 weeks ]
  • Change of MIC of P. aeruginosa during a continuous treatment with 1 x 300 mg/d and 2 x 300 mg/d TNS. [ Time Frame: 8 weeks ]
  • Assess safety of a continuous daily dosing regimen with 1 x 300 mg/d and 2 x 300 mg/d TNS over 8 weeks, compared to historic safety data of the 4 week on/off dosing regimen with 2 x 300 mg/d. [ Time Frame: 8 weeks ]


Original Secondary Outcome: Serum PK of tobramycin of continuous daily dosing regimens. Serum PK of tobramycin in CF-Subjects with a FEV1≥80% vs. CF-Subjects with a FEV1<80%. Change of MIC of P aeruginosa in both treatments. Safety of a continuous daily dosing regimen [ Time Frame: 8 wks ]

Information By: Novartis

Dates:
Date Received: March 4, 2008
Date Started: February 2008
Date Completion:
Last Updated: February 22, 2017
Last Verified: February 2017