Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years

Summary

This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.

Timeline

Start

2010-04

Primary completion

2015-06

Completion

2015-06

Outcome

Met primary endpoint

registry TOBI (Tobramycin Inhaled Solution)/Placebo vs Placebo/TOBI; p <0.001; Odds Ratio (OR) 21.55 (95% CI 4.67 to 99.52) NCT01082367 ↗

paper On Day 29, 84.6% patients in the TOBI versus 24.0% in the placebo group were Pa-free (p < 0.001). PMID 29685813 ↗

Publications

• Ratjen F, Moeller A, McKinney ML, Asherova I, Alon N, Maykut R, Angyalosi G; EARLY study group. Eradication of early P. aeruginosa infection in children <7 years of age with cystic fibrosis: The early study. J Cyst Fibros. 2019 Jan;18(1):78-85. doi: 10.1016/j.jcf.2018.04.002. Epub 2018 Apr 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tobramycin	Unknown	300 mg	Inhaled

Indications