TOBI Podhaler Profile
Summary	The new TOBI Podhaler is a twice-daily inhaled dry powder antibiotic that provides the same level of efficacy and safety as nebulized TOBI with greatly simplified administration.
Indication	The TOBI Podhaler is indicated for CF patients with P aeruginosa.
Efficacy
FEV1	Patients treated with TOBI Podhaler experienced a 13.3% improvement in FEV1 percent predicted compared to placebo at 28 days (p=0.0016) Improvements in FEV1 with patients on TOBI Podhaler were equivalent to nebulized TOBI at all time points over the course of a large 6-month study.
Sputum density	The mean decrease in P aeruginosa sputum density from baseline was greater for TOBI Podhaler than TOBI on day 28 of each cycle.
FVC	Patients treated with the TOBI Podhaler experienced an 11% improvement in FVC percent predicted compared to placebo at 28 days.
Additional Benefits
	No nebulizer An easy-to-use, lightweight, portable device, no battery needed No set up, clean up, or disinfection needed Accurate dosing No refrigeration or reconstitution required 5-minute administration
Safety & Tolerability	TOBI Podhaler demonstrated similar safety and tolerability to TOBI except: cough, disphonia and disgeuzia. Higher rates of cough were observed within the first week of use and subsided to those similar to TOBI thereafter. Most events were mild and moderate and rarely led to discontinuation.