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Clinical trials identifierNCT01082367 
Study codesCTBM100C2304, EARLY 
Study titleA 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
Drug (brand name)Tobi (tobramycin)
Drug administrationInhalation
Eligible CF patientsPeople with CF aged 3 months to less than 7 years, and early lower respiratory tract infection with Pseudomonas aeruginosa (Pa)
Controlled study?Yes, placebo controlled
Randomised study?Yes
Blinded study?Yes (double blinded. Neither the participant, nor the medical staff knows which group the participant is in)
Extension study?No
Study timeframeThe study was conducted between April 2010 and June 2015

Study:This Phase 3 study was conducted in 19 sites across 10 countries.
Aim:The aim was to determine the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis. 
Participants:51 children with CF were enrolled and randomized to receive placebo (25 children) or TOBI (26 children) twice daily for 28 days. 
There were 4 participants from 6 ECFS-CTN sites in France, Germany and Italy. (Bordeaux, Reims, Debré, Frankfurt, Koln, Milan). 
Treatment:Children received inhaled placebo or TOBI twice daily for 28 days. After this, children could carry on treatment or “cross-over” treatment for another 28 days depending on whether they were still positive for PA, as follows:
•    Children initially in the TOBI group and positive for Pa could continue TOBI
•    Children initially in the TOBI group and negative for Pa could cross over to placebo 
•    Children initially in the placebo group and positive for Pa could cross over to TOBI
•    Children initially in the placebo group and negative for Pa could cross over to TOBI 
Efficacy:    At the end of the first 28-day treatment cycle, 84.6% of children who were treated with TOBI were free from Pa infection, compared to 24% of children who were treated with placebo. The difference between groups was statistically significant (p<0.001).
At the end of the 91-day testing period, the percentage of children free of PA infection was:
•    76% for children who took TOBI first then switched to placebo
•    47.8% for children who took placebo first then switched to TOBI
Safety:There were no serious adverse events in the TOBI groups in this study. The most common adverse event was cough.
Data source:This preliminary summary of data provided here is from