The ECFS-CTN cannot guarantee that the information provided here is comprehensive. Please go to the ClinicalTrials.gov link for detailed and up-to-date information on study background, eligibility criteria, study design, outcome measures, study status, participating sites, sponsor contact information and timelines.
You can also contact the CTN coordinating centre for additional information: ECFS-CTN@uzleuven.be (link sends e-mail)
| Study Name on ClinicalTrials.gov (link is external) | Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways (PALS) |
|---|---|
| Study Drug | Aztreonam Lysine for Inhalation (AZLI) |
| Type of Study Drug | Anti-infective |
| Study Title | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways |
| Study Phase | 3 |
| Study Sponsor | Gilead |
http://clinicaltrials.gov/ct2/show/NCT01404234 (link is external) | |
| Participating ECFS-CTN sites | France: Bordeaux, Paris (Necker) Germany: Berlin, Frankfurt Italy: Florence, Verona Spain: Barcelona |
| Age | Children ? 12 years of age |