CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 47 enrolled
Drug / intervention
Treatment A +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04600505
NCT04600505Phase 1Completed
CompareCT.gov

A Randomized, Single Blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared With BGF MDI HFA in Healthy Subjects

AstraZeneca·interventional·Posted Oct 23, 2020·Updated Jan 23, 2023

In Brief

A Phase 1 clinical trial evaluating Treatment A, Treatment B, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 47 participants across 1 site.

Detailed Summary

The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A \[test\]), Propellant 2 (Treatment B \[test\]) and Hydrofluoroalkane (HFA) (Treatment C \[reference\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
CollaboratorsParexel

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedOct 23, 2020
Enrollment StartOct 19, 2020
Primary CompletionMay 17, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.7 years ago

Interventions

Treatment Adrug

Participants will receive 2 inhalations of BGF MDI with propellant 1.

Treatment Bdrug

Participants will receive 2 inhalations of BGF MDI with propellant 2.

Treatment Cdrug

Participants will receive 2 inhalations of BGF MDI with HFA propellant.