A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
Status:
Completed
Trial end date:
2018-10-11
Target enrollment:
Participant gender:
Summary
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.