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) | Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years (EARLY) |
|---|---|
| Study Drug | TOBI (tobramycin inhaled solution) |
| Type of Study Drug | Anti-infective |
| Study Title | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years. |
| Study Phase | 3 |
| Study Sponsor | Novartis Pharmaceuticals |
http://clinicaltrials.gov/ct2/show/NCT01082367 (link is external) | |
| Participating ECFS-CTN sites | Germany: Frankfurt, Cologne France: Bordeaux, West-Paris, Reims Italy: Milan |
| Age | Between 3 months and less than 7 years |