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

NCT03740373 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-14

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Samuel Israel · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
28 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-04
Primary Completion
2018-10-11
Completion
2018-10-11

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03740373 on ClinicalTrials.gov