Chronic Obstructive Pulmonary DiseasePhase 1NCT05569421

A Study to Assess the Total Systemic Exposure Bioequivalence of of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI With Next-Generation Propellant Compared With BGF MDI With HFA Propellant

A Phase 1 study testing Treatment A: BGF MDI HFO and Treatment B: BGF MDI HFA in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study will evaluate bioequivalence, pharmacokinetics, safety, and tolerability of Budesonide, Glycopyrronium and Formoterol (BGF) metered dose inhaler (MDI) formulated with hydrofluoroolefin (HFO) [Test] and hydrofluoroalkane (HFA) [Reference] in healthy participants (male or female). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Treatment A: BGF MDI HFO and Treatment B: BGF MDI HFA
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 1 siteUnited States
Study dates: 11 Oct 2022to 14 Apr 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female subjects aged 18 to 60 years with suitable veins for cannulation or repeated venepuncture.
Females must have a negative pregnancy test, must not be lactating
Have a Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
Subjects must have a FEV1 ≥ 80% of the predicted normal value and an FEV1/FVC > 70% regarding age, height, and ethnicity.
Subjects must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.

Who cannot join

History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate.
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 not adequately treated and/or change in vision that may be relevant.
History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
Unresectable cancer that has not been in complete remission for at least 5 years.

Show all 23Show fewer

Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results at screening, as judged by the investigator.
Any clinically significant abnormalities on 12-lead electrocardiogram (ECG)
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus (HIV) antibody.
Subject has a positive Reverse transcriptase- Polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Subject has clinical signs and symptoms consistent with SARS-CoV-2 infection, eg, fever, dry cough, dyspnea, sore throat, fatigue, or laboratory confirmed acute infection with SARS-CoV-2.
Subject who had severe course of Corona virus disease of 2019 (COVID-19) (extracorporeal membrane oxygenation, mechanically ventilated, Intensive Care Unit stay).
History of any respiratory disorders such as asthma, Chronic Obstructive Pulmonary Disorder (COPD), or idiopathic pulmonary fibrosis.
Known or suspected history of alcohol or drug abuse.
Receipt of any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization.
Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.
History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
Use of any prescribed or non-prescribed medication including antacids, analgesics (other than paracetamol/acetaminophen), herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP.
Known or suspected history of alcohol or drug abuse or excessive intake of alcohol.
Excessive intake of caffeine-containing drinks or food. Excessive intake of caffeine defined as the regular consumption of more than 600 mg of caffeine per day or would likely be unable to refrain from the use of caffeine-containing beverages during confinement.
Subjects who have previously received BGF MDI HFO.

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Phase I, Randomized, Double-blind, Single-dose, Partial-replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA

Read the detailed description

This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3 way cross-over study to assess pharmacokinetic and safety of BGF MDI when administered with different propellants, HFO (HFO-1234ze) - test and HFA (HFA-134a) - reference.

The study will comprise of:

A screening period up to 28 days prior to first dosing;
Three Treatment Periods: Participants will be resident at the Clinical Unit from the morning on the day before dosing with BGF MDI on Day -1 of Treatment Period 1, until 24 hours following the final dose on Day 2 of Treatment Period 3, with a washout period of 3 to 7 days between each dose; and
Follow-up: final safety Follow-up Phone Call within 3 to 7 days after the last administration of BGF MDI in Treatment Period 3.

Each participant will receive 3 single dose treatments of BGF MDI (Treatment A: BGF MDI HFO [Test]; Treatment B: BGF MDI HFA [Reference]) following an overnight fast of at least 8 hours on Day 1 of each treatment period.

The reference formulation will be administered during 2 of the 3 treatment periods.

There will be a minimum of a 3 to 7 day washout between administration of each treatment.

Each participant will be involved in the study for approximately 55 days.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Treatment A: BGF MDI HFO, Treatment B: BGF MDI HFA
Keywords: Bioequivalence, Propellant, Corticosteroid, Long acting muscarine agonist (LAMA), Long acting beta agonist, Lung exposure, Healthy subjects, Inhaled corticosteroid (ICS), Long-acting β2 agonist (LABA), Next generation propellant (NGP)
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A: BGF MDI HFODrug
Also called Budesonide/Glycopyronium/Formoterol fumarate pressurized inhalation suspension, HFO
Participants will receive 4 oral inhalations as a single dose - test formulation; administered during 1 treatment period.
Treatment B: BGF MDI HFADrug
Also called Budesonide/Glycopyronium/Formoterol fumarate pressurized inhalation suspension, HFA
Participants will receive 4 oral inhalations as a single dose - reference formulation; administered during 2 treatment periods.

Study groups in NCT05569421
Study group	Role	What they receive
Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator	Experimental	Participants will receive Test formulation in 1 of 3 possible treatment sequences: ABB, BAB, or BBA. The reference formulation will be administered during 2 of the 3 treatment periods in order to estimate intra-subject variability. Receives: Drug: Treatment A: BGF MDI HFO; Drug: Treatment B: BGF MDI HFA
Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator	Experimental	Participants will receive Reference formulation in 1 of 3 possible treatment sequences: ABB, BAB, or BBA. The reference formulation will be administered during 2 of the 3 treatment periods in order to estimate intra-subject variability. Receives: Drug: Treatment A: BGF MDI HFO; Drug: Treatment B: BGF MDI HFA

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf)
The AUCinf of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)
The AUClast of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
The Cmax of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)

Secondary outcomes (7)

Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
The tmax of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz)
The λz of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
The t½λz of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRTinf)
The MRTinf of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
The CL/F of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
The Vz/F of budesonide, glycopryrronium and formoterol in participants was evaluated.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
The safety and tolerability of single doses of BGF MDI HFO and BGF MDI HFA was evaluated in healthy participants.
Measured: From Screening up to Follow-up (3 to 7 days post final dose) [approximately 55 days]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 202214 Apr 2023

First posted6 Oct 2022
Study start11 Oct 2022
Primary completion14 Apr 2023
Study completion14 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 108 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05569421
Sponsor's protocol ID: D5985C00004
Status last verified: Jul 2025
First submitted: 4 Oct 2022
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

Bednarczyk A, Aurivillius M, Jassal M, Shah M, Raphiou I, Petullo D, Xu J, Heijer M, Sychowicz K, Collison K, Silva C, Reddy J, Han D, Goldwater R, Gillen M, Patel M. Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and total systemic exposure studies. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261417149. doi: 10.1177/17534666261417149. Epub 2026 Feb 12.
PubMed 41677208

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-blind, Single-dose, Partial-replicate, 3-way Cross-over Study to Assess the Total Systemic Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA
ClinicalTrials.gov ID: NCT05569421
Acronym / sponsor ID: D5985C00004
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Bioequivalence, Propellant, Corticosteroid, Long acting muscarine agonist (LAMA), Long acting beta agonist, Lung exposure, Healthy subjects, Inhaled corticosteroid (ICS)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 108 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 11 Oct 2022 (actual)
Primary completion: 14 Apr 2023 (actual)
Study completion: 14 Apr 2023 (actual)
First posted: 6 Oct 2022 (actual)
Results: Posted 29 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will comprise of:

A screening period up to 28 days prior to first dosing;
Three Treatment Periods: Participants will be resident at the Clinical Unit from the morning on the day before dosing with BGF MDI on Day -1 of Treatment Period 1, until 24 hours following the final dose on Day 2 of Treatment Period 3, with a washout period of 3 to 7 days between each dose; and
Follow-up: final safety Follow-up Phone Call within 3 to 7 days after the last administration of BGF MDI in Treatment Period 3.

The reference formulation will be administered during 2 of the 3 treatment periods.

There will be a minimum of a 3 to 7 day washout between administration of each treatment.

Each participant will be involved in the study for approximately 55 days.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator	Experimental	Drug: Treatment A: BGF MDI HFO, Drug: Treatment B: BGF MDI HFAParticipants will receive Test formulation in 1 of 3 possible treatment sequences: ABB, BAB, or BBA. The reference formulation will be administered during 2 of the 3 treatment periods in order to estimate intra-subject variability.
Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator	Experimental	Drug: Treatment A: BGF MDI HFO, Drug: Treatment B: BGF MDI HFAParticipants will receive Reference formulation in 1 of 3 possible treatment sequences: ABB, BAB, or BBA. The reference formulation will be administered during 2 of the 3 treatment periods in order to estimate intra-subject variability.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Healthy male and female subjects aged 18 to 60 years with suitable veins for cannulation or repeated venepuncture.
Females must have a negative pregnancy test, must not be lactating
Have a Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
Subjects must have a FEV1 ≥ 80% of the predicted normal value and an FEV1/FVC > 70% regarding age, height, and ethnicity.

Key exclusion criteria (23 listed)

History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate.
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 not adequately treated and/or change in vision that may be relevant.
History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment A: BGF MDI HFOAlso: Budesonide/Glycopyronium/Formoterol fumarate pressurized inhalation suspension, HFOParticipants will receive 4 oral inhalations as a single dose - test formulation; administered during 1 treatment period.	Drug	Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator, Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator
Treatment B: BGF MDI HFAAlso: Budesonide/Glycopyronium/Formoterol fumarate pressurized inhalation suspension, HFAParticipants will receive 4 oral inhalations as a single dose - reference formulation; administered during 2 treatment periods.	Drug	Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator, Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator

Primary outcome

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
The AUCinf of budesonide, glycopryrronium and formoterol in participants was evaluated.
Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
The AUClast of budesonide, glycopryrronium and formoterol in participants was evaluated.
Maximum Observed Plasma (Peak) Drug Concentration (Cmax)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
The Cmax of budesonide, glycopryrronium and formoterol in participants was evaluated.

7 secondary outcomes

Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant, Estimated by Log-linear Least Squares Regression of the Terminal Part of the Concentration-time Curve (λz)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Half-life Associated With Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity (MRTinf)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Apparent Total Body Clearance of Drug From Plasma After Extravascular Administration (CL/F)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Based on Terminal Phase) (Vz/F)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Screening up to Follow-up (3 to 7 days post final dose) [approximately 55 days]

Results and safety

Results posted to the registry on 29 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence ABB	36	35
Treatment Sequence BAB	36	36
Treatment Sequence BBA	36	36

Primary outcome: Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf)

Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days). Geometric mean (Geometric Coefficient of Variation). Unit: hour*picogram/milliliter (h*pg/mL)

Measure	Treatment A n = 108	Treatment B (Replicate 1) n = 107	Treatment B (Replicate 2) n = 107
Budesonide	4047 (46.71)	4112 (40.78)	4012 (46.01)
Glycopyronium	85.62 (94.55)	81.10 (78.85)	120.9 (83.40)
Formoterol	124.3 (43.80)	121.3 (41.19)	125.0 (40.55)

Population analysed: The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least one primary PK parameter could be calculated and who had no IPDs or AEs thought to impact the analysis of the PK data. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.

Primary outcome: Area Under the Plasma Concentration-curve From Zero to the Last Quantifiable Concentration (AUClast)

Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days). Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	Treatment A n = 105	Treatment B (Replicate 1) n = 103	Treatment B (Replicate 2) n = 104
Budesonide	3943 (47.60)	4003 (40.66)	3905 (46.82)
Glycopyrronium	52.68 (52.68)	49.31 (84.38)	63.29 (72.90)
Formoterol	102.5 (48.47)	100.3 (45.89)	103.9 (42.47)

Population analysed: The PK analysis set consisted of all participants in the safety analysis set for whom at least one primary PK parameter could be calculated and who had no IPDs or AEs thought to impact the analysis of the PK data. Here, N = number of participants analyzed refers to n = number analyzed for this outcome measure at specific timepoints.

Primary outcome: Maximum Observed Plasma (Peak) Drug Concentration (Cmax)

Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days). Geometric mean (Geometric Coefficient of Variation). Unit: picograms per milliliter (pg/mL)

Measure	Treatment A n = 105	Treatment B (Replicate 1) n = 103	Treatment B (Replicate 2) n = 104
Budesonide	1124 (65.67)	1143 (60.79)	1146 (65.91)
Glycopyrronium	17.09 (90.52)	20.41 (87.46)	19.70 (87.52)
Formoterol	23.48 (60.12)	24.54 (62.22)	26.12 (54.39)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Screening up to Follow-up Phone call (3 to 7 days post final dose) [approximately 55 days]. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 108 (0%)	16 of 108 (14.8%)	0 of 108
Treatment B (Replicate 1)	0 of 107 (0%)	21 of 107 (19.6%)	0 of 107
Treatment B (Replicate 2)	0 of 107 (0%)	9 of 107 (8.4%)	0 of 107

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41677208Bednarczyk A, Aurivillius M, Jassal M, Shah M, Raphiou I, Petullo D, Xu J, Heijer M, Sychowicz K, Collison K, Silva C, Reddy J, Han D, Goldwater R, Gillen M, Patel M. Bioequivalence of budesonide/glycopyrrolate/formoterol fumarate with a next-generation propellant versus hydrofluoroalkane-134a in healthy adults: phase I, randomized, double-blind, single-dose, partial-replicate, three-way cross-over lung exposure and total systemic exposure studies. Ther Adv Respir Dis. 2026 Jan-Dec;20:17534666261417149. doi: 10.1177/17534666261417149. Epub 2026 Feb 12.
Redacted CSP and SAPLink provided by the sponsor.
Redacted CSR synopsisLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Treatment A: BGF MDI HFO and Treatment B: BGF MDI HFA in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under Plasma Concentration-time Curve From Zero to Infinity (AUCinf) (time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05569421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.