NCT03740373

A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 28 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. This inhaler is intended to be used in the treatment of Chronic Obstructive Pulmonary Disease (COPD), which is a group of diseases which cause lung problems and difficulty breathing. PT010 contains a combination of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide. Budesonide is a corticosteroid that works by preventing inflammation and thus can aid in respiratory diseases such as chronic obstructive pulmonary disease. Glycopyrronium \& Formoterol Fumarate are bronchodilators which act by relaxing the smooth muscle cells in the trachea and bronchi, allowing greater airflow into the lungs. To enable us to determine how much of the drug gets into the lungs following different lengths of breath hold, a technique called gamma scintigraphy will be used. Gamma scintigraphy is a technique used to track the movement of a radiolabelled tracer inside the body. By assessing the amount of PT010 in the lungs following different lengths of breath hold, it is intended that this information will provide guidance as to the most effective way of taking the inhaler. 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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold	Participants will receive a single dose of BGF MDI; the dose will be administered with a 10 s breath-hold.
DRUG	BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold	Participants will receive a single dose of BGF MDI; the dose will be administered with a 3 s breath-hold.

Timeline

• Start date: 2018-09-04
• Primary completion: 2018-10-11
• Completion: 2018-10-11
• First posted: 2018-11-14
• Last updated: 2018-11-14

Locations

1 site across 1 country: United Kingdom