A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults

Completed · Phase 1

Conditions studied: Healthy Participants

In brief

This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.

Key facts

Study ID

NCT06723756

Run by

AstraZeneca

People needed

105

Starts

2025-01-23

Expected to finish

2025-06-01

Last updated by the study team

2025-06-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy participants with suitable veins for cannulation or repeated venipuncture.
• All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
• Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
• Females of non-childbearing potential must be confirmed at the Screening Visit.
• Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
• Participants must have a forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value (based on age, height, ethnicity and gender at birth) and an FEV1/forced vital capacity (FEV1/FVC) > 70% at the Screening Visit. FEV1/FVC can be reported as ratio ie, 0.7 or a percentage ie, 70%.
• Participants must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.

You may not qualify if…

• History of any clinically significant disease that put the participant at risk of participation.
• History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
• Any clinically significant illness, medical/surgical procedure, history of narrow angle glaucoma not adequately treated, or bladder neck obstruction/urinary retention.
• Unresectable cancer that has not been in complete remission for at least 5 years.
• Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis results, or vital signs at Screening.
• Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at Screening.
• Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
• History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
• Known or suspected history of alcohol or drug abuse as judged by the Investigator.
• Current smokers or those who have smoked or used nicotine products (including e cigarettes).
• Excessive intake of caffeine-containing drinks or food.

Where it is running

• Research Site — Brooklyn, Maryland, United States

Full record on ClinicalTrials.gov

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