Dataset from A Phase I, Randomised, Two-Period, Single-Dose, Single-Centre, Crossover Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI, Following 3 s and 10 s Breath-Hold, in Healthy Male Subjects

This study is a 2 treatment period, single dose crossover, gamma scintigraphy study
investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol
Fumarate Metered Dose Inhaler.

This study will be investigating how the drug (known as PT010) is distributed in the lungs
following a 10 second or 3 second breath hold.

The study will involve the following visits: 1 screening visits, 2 treatment visits, each
separated by around 7 days (each with 1 overnight stay; from the evening before dosing until
a minimum of 4 hours post-dose on the morning of Day 1) and a post-study follow up phone
call.

The study population will be 10 healthy males, aged between 28 and 50 years of age.