Moeller

Fakultäten » Medizinische Fakultät » Kinderspital Zürich: Medizinische Klinik » Pneumologie » PD Dr. Alexander Möller » Moeller

Completed research project

Title / Titel	An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen, in Subjects with Cystic Fibrosis Followed by an Open-Label, Single Arm Extension
PDF	Abstract (PDF, 14 KB)
Summary / Zusammenfassung	This is an open-label, multicenter, randomized, parallel group study in subjects with CF whose pulmonary disease is stable and who have a recent positive sputum culture for Pseudomonas aeruginosa (PA) at study entry. The study design consists of two treatment arms of 28-day, intermittent, repeating treatment regimens: Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) or Tobramycin Nebuliser Solution (TNS). The total study period will be 26 weeks. The study schedule will contain nine visits – Screening, Baseline, Day 14, Day 28, then visits every 28 days through the end of the study. An open-label, single-arm extension is available for subjects who have completed at least one course of AZLI or TNS during the randomized portion of the study. Subjects may be eligible to receive three additional cycles of AZLI in a 28-day, intermittent, repeating treatment regimen.
Publications / Publikationen	none
Keywords / Suchbegriffe	cystic fibrosis, antibiotics, Pseudomonas aeruginosa, children, inhaled therapie
Project leadership and contacts / Projektleitung und Kontakte	Dr. Alexander Moeller (Project Leader) alexander.moeller@kispi.uzh.ch
Funding source(s) / Unterstützt durch	Private Sector (e.g. Industry)
Duration of Project / Projektdauer	Sep 2009 to Aug 2010