A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer

NCT06297668 | Completed Phase 1 FDA Drug FDA Device

• 2 other identifiers: D5985C000082023-504089-43-00
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Metered Dose Inhalers (MDI); Propellant; Next Generation Propellant (NGP); Inhaled Corticosteroid (ICS); Long-acting muscarinic antagonist (LAMA); Long-acting beta2 agonist (LABA); Total Systemic exposure; Healthy participants

Outcome Measures

Primary Outcomes (2)

• Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI

  To assess that the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with AeroChamber Plus Flow-Vu spacer does not exceed that with BGF MDI HFA with AeroChamber Plus Flow-Vu spacer.

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

• Maximum Observed Concentration (Cmax) of BGF MDI

  To assess that the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with AeroChamber Plus Flow-Vu spacer does not exceed that with BGF MDI HFA with AeroChamber Plus Flow-Vu spacer.

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

Secondary Outcomes (10)

• Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast)

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

• Maximum Observed Concentration (Cmax)

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

• Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

• Time to Reach Maximum Observed Concentration (tmax)

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

• Terminal Rate Constant (λz)

  Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

Study Arms (3)

BGF MDI HFA

ACTIVE COMPARATOR

Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroalkane with AeroChamber Plus Flow-Vu spacer-reference formulation

Drug: Treatment A: BGF MDI HFA; Device: AeroChamber Plus Flow-Vu spacer

BGF MDI HFO with spacer

ACTIVE COMPARATOR

Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin with AeroChamber Plus Flow-Vu spacer-test formulation

Drug: Treatment B: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu spacer

BGF MDI HFO without spacer

ACTIVE COMPARATOR

Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin without AeroChamber Plus Flow-Vu spacer

Drug: Treatment C: BGF MDI HFO

Interventions

Treatment A: BGF MDI HFA DRUG

Participants will receive 4 inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer.

BGF MDI HFA

Treatment B: BGF MDI HFO DRUG

Participants will receive 4 inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer.

BGF MDI HFO with spacer

Treatment C: BGF MDI HFO DRUG

Participants will receive 4 inhalations of BGF MDI HFO as a single dose without spacer.

BGF MDI HFO without spacer

AeroChamber Plus Flow-Vu spacer DEVICE

Participants will receive 4 inhalations of BGF MDI HFA (Treatment A) and BGF MDI HFO (Treatment B) as a single dose with spacer.

BGF MDI HFA; BGF MDI HFO with spacer

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating, confirmed at screening.
• Women of childbearing potential who are sexually active with a non-sterilized male partner, must use 1 highly effective form of birth control from enrolment throughout the study and until at least 14 days after last dose of IMP. Women should be stable on their chosen method of birth control for at least 1 month from enrolment.
• Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
• Have a Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/forced vital capacity\> 70% regarding age, height, and ethnicity at screening.
• Demonstrate basic understanding of how to use an MDI device with and without a spacer after receiving training.
• Participants should be fully/sufficiently vaccinated as per local definitions against SARS-CoV-2 (in combination with confirmed past infections with SARS-CoV-2).

You may not qualify if:

• History or current evidence of any clinically significant disease or disorder, including endocrinological diseases, such as thyrotoxicosis, which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results through participation in the study.
• Participants who have previously received BGF MDI HFO.
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to BGF or to its excipients, such as norflurane.
• 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, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
• History of narrow angle glaucoma or change in vision that may be relevant.
• History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, which in the opinion of the investigator, is clinically significant.
• Unresectable cancer that has not been in complete remission for at least 5 years.
• Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator.
• Any clinically significant abnormal findings in physical examination or vital signs at screening, as judged by the investigator.
• Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the investigator.
• Any positive result on screening for serum hepatitis B surface antigen or anti-hepatitis B core antibody, indicative of hepatitis B, hepatitis C antibody, or human immunodeficiency virus.
• Positive reverse transcription polymerase chain reaction test for SARS-CoV-2 prior to randomization.
• Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
• Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, or mechanically ventilated).

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Berlin, 14050, Germany

Location

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 7, 2024
• Study Start: April 29, 2024
• Primary Completion: June 11, 2024
• Study Completion: June 11, 2024
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

DE (1)