Chronic Obstructive Pulmonary DiseasePhase 1NCT05477108

Study to Assess the Lung Exposure Bioequivalence 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 with oral activated charcoal) and Treatment B (BGF MDI HFA with oral activated charcoal) 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 assess the Pharmacokinetic (PK) and safety of BGF MDI [Budesonide/glycopyrronium/formoterol (BGF) metered dose inhaler (MDI)] formulated with 2 different propellants :Hydrofluoroolefin (HFO) and Hydrofluoroalkane (HFA) with oral activated charcoal in healthy subjects (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 with oral activated charcoal) and Treatment B (BGF MDI HFA with oral activated charcoal)
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: 29 Jul 2022to 11 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

Healthy non-smoking male and/or female subjects aged 18 - 60 years with suitable veins for cannulation or repeated venipuncture.
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, confirmed at screening.
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 Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/FVC (Forced vital capacity) > 70% regarding age, height, and ethnicity at the screening visit.
Subjects must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.
Provision of signed and dated, written informed consent prior to any study specific procedures.

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.
Unresectable cancer that has not been in complete remission for at least 5 years.

Show all 27Show fewer

Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
Any clinically significant abnormal findings in physical examination, 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, and HIV antibody.
Subject has a positive RT-PCR test for SARS-CoV-2 prior to randomization.
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 COVID-19 (extracorporeal membrane oxygenation, mechanically ventilated, Intensive Care Unit stay).
Recent (within 14 days prior to admission to the Clinical Unit) exposure to someone who has COVID-19 symptoms or tested positive for SARS-CoV-2.
Has a current occupation that involves routine exposure to potential COVID-19 patients or sources of SARS-CoV-2 infection (eg, healthcare worker).
History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
Known or suspected history of 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 or history of hypersensitivity to drugs with a similar chemical structure or class to BGF.
Current smokers or those who have smoked or used nicotine products (including e cigarettes) within 3 months prior to screening.
Positive screen for drugs of abuse or cotinine at screening or on admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit.
Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.
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
Brooklyn, Maryland, 21225

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 Lung 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.

The study will comprise:

Screening period: up to 28 days prior to first dosing;
Three treatment periods : Subject will be resident in the Clinical Unit from the morning on the day before dosing with BGF MDI (Day 1 of Treatment Period 1), until 24 hours following the final dose (Day 2 of Treatment Period 3 a washout period of 3 to 7 days between each dose;
Follow-up: Within 3 to 7 days after the last administration of BGF MDI.

Subjects will receive 3 single-dose treatments of BGF MDI [Test formulation Treatment A (BGF MDI HFO); Reference formulation Treatment B (BGF MDI HFA)] on Day 1 of each Treatment Period (1, 2, and 3) following an overnight fast of at least 8 hours. There will be a washout period of 3 to 7 days between each dose.

Each subjects will be involved in the study for up to 55 days.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Treatment A (BGF MDI HFO with oral activated charcoal), Treatment B (BGF MDI HFA with oral activated charcoal)
Keywords: Corticosteroid, Long acting muscarine agonist (LAMA), Long acting beta agonist, Propellant, Bioequivalence, 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 HFO with oral activated charcoal)Drug
Also called Budesonide / Glycopyronium / Formoterol fumarate pressurized inhalation suspension, HFO
Subject will receive 4 inhalations as a single dose with oral activated charcoal - test formulation; administered during 1 Treatment Period.
Treatment B (BGF MDI HFA with oral activated charcoal)Drug
Also called Budesonide / Glycopyronium / Formoterol fumarate pressurized inhalation suspension, HFA
Subject will received 4 inhalations as a single dose with oral activated charcoal - reference formulation; administered during 2 Treatment Periods.

Study groups in NCT05477108
Study group	Role	What they receive
Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator with oral activated charcoal	Experimental	Subjects 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 with oral activated charcoal); Drug: Treatment B (BGF MDI HFA with oral activated charcoal)
Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator with oral activated charcoal	Experimental	Subjects 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 with oral activated charcoal); Drug: Treatment B (BGF MDI HFA with oral activated charcoal)

What is being measured

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

Maximum Observed Plasma (Peak) Drug Concentration (Cmax )
Bioequivalence (Cmax) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hours (h), 2 h, 4 h, 8 h, 12h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUCinf)
Bioequivalence (AUCinf) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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)
Bioequivalence (AUClast) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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 as PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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 as PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant (λz)
The λz PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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 PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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 PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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 PK profiles of BGF administered as BGF MDI HFO and BGF MDI HFA with oral activated charcoal was assessed.
Measured: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Number of Participants With Adverse Events
The safety and tolerability of single doses of BGF MDI HFO and BGF MDI HFA with oral activated charcoal in healthy subjects was assessed.
Measured: From screening (Day -28 to Day -1) up to 55 days

Timeline

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

29 Jul 202211 Apr 2023

First posted28 Jul 2022
Study start29 Jul 2022
Primary completion11 Apr 2023
Study completion11 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: NCT05477108
Sponsor's protocol ID: D5985C00005
Other IDs: 118313
Status last verified: Aug 2025
First submitted: 26 Jul 2022
Last updated: 28 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 28 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 Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol Delivered by BGF MDI HFO Compared With BGF MDI HFA
ClinicalTrials.gov ID: NCT05477108
Acronym / sponsor ID: D5985C00005
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Corticosteroid, Long acting muscarine agonist (LAMA), Long acting beta agonist, Propellant, Bioequivalence, 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: 29 Jul 2022 (actual)
Primary completion: 11 Apr 2023 (actual)
Study completion: 11 Apr 2023 (actual)
First posted: 28 Jul 2022 (actual)
Results: Posted 28 May 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

This is a Phase I, randomized, double-blind, single-dose, single-center, partial-replicate, 3 way cross-over study.

The study will comprise:

Screening period: up to 28 days prior to first dosing;
Three treatment periods : Subject will be resident in the Clinical Unit from the morning on the day before dosing with BGF MDI (Day 1 of Treatment Period 1), until 24 hours following the final dose (Day 2 of Treatment Period 3 a washout period of 3 to 7 days between each dose;
Follow-up: Within 3 to 7 days after the last administration of BGF MDI.

Each subjects will be involved in the study for up to 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 with oral activated charcoal	Experimental	Drug: Treatment A (BGF MDI HFO with oral activated charcoal), Drug: Treatment B (BGF MDI HFA with oral activated charcoal)Subjects 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 with oral activated charcoal	Experimental	Drug: Treatment A (BGF MDI HFO with oral activated charcoal), Drug: Treatment B (BGF MDI HFA with oral activated charcoal)Subjects 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)

Healthy non-smoking male and/or female subjects aged 18 - 60 years with suitable veins for cannulation or repeated venipuncture.
Females must have a negative pregnancy test at screening and on admission to the unit, must not be lactating, confirmed at screening.
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 Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/FVC (Forced vital capacity) > 70% regarding age, height, and ethnicity at the screening visit.
Subjects must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.

Key exclusion criteria (27 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.

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 HFO with oral activated charcoal)Also: Budesonide / Glycopyronium / Formoterol fumarate pressurized inhalation suspension, HFOSubject will receive 4 inhalations as a single dose with oral activated charcoal - test formulation; administered during 1 Treatment Period.	Drug	Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator with oral activated charcoal, Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator with oral activated charcoal
Treatment B (BGF MDI HFA with oral activated charcoal)Also: Budesonide / Glycopyronium / Formoterol fumarate pressurized inhalation suspension, HFASubject will received 4 inhalations as a single dose with oral activated charcoal - reference formulation; administered during 2 Treatment Periods.	Drug	Treatment A: BGF MDI HFO 160/7.2/4.8 μg ex-actuator with oral activated charcoal, Treatment B: BGF MDI HFA 160/7.2/4.8 μg ex-actuator with oral activated charcoal

Primary outcome

Maximum Observed Plasma (Peak) Drug Concentration (Cmax )
Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hours (h), 2 h, 4 h, 8 h, 12h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Bioequivalence (Cmax) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Area Under Plasma Concentration Time Curve From Zero to Infinity (AUCinf)
Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Bioequivalence (AUCinf) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.
Area Under the Plasma Concentration Curve From Zero to the Last Quantifiable Concentration (AUClast)
Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Bioequivalence (AUClast) of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO compared with BGF MDI HFA was assessed.

7 secondary outcomes

Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (Tmax)
Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant (λz)
Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on 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: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Number of Participants With Adverse Events
Time frame: From screening (Day -28 to Day -1) up to 55 days

Results and safety

Results posted to the registry on 28 May 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	35
Treatment Sequence BBA	36	33

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

Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hours (h), 2 h, 4 h, 8 h, 12h and 24 hours post-dose on 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 = 101	Treatment B (Replicate 1) n = 97	Treatment B (Replicate 2) n = 99
Budesonide	1078 (61.09)	1111 (63.42)	1045 (73.36)
Glycopyrronium	14.31 (98.78)	15.22 (96.13)	15.17 (92.85)
Formoterol	18.82 (75.45)	19.31 (74.53)	19.35 (80.39)

Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 104.24 (90% CI 95.78 to 113.44)
Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 93.45 (90% CI 84.31 to 103.58)
Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 100.14 (90% CI 91.90 to 109.11)

Population analysed: The PK analysis set consisted of all randomized participants who had at least 1 primary PK parameter that could be calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Here, number of participants analyzed refers to number analyzed for each specific outcome measure.

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

Time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 h, 2 h, 4 h, 8 h, 12 h and 24 hours post-dose on Day 1 and Day 2 of each treatment period (each treatment period is of 2 days). Geometric mean (Geometric Coefficient of Variation). Unit: hour (h)*pg/mL

Measure	Treatment A n = 101	Treatment B (Replicate 1) n = 96	Treatment B (Replicate 2) n = 99
Budesonide	2533 (61.57)	2479 (61.34)	2507 (76.08)
Glycopyrronium	45.66 (245.3)	33.60 (223.9)	64.50 (271.8)
Formoterol	54.12 (85.90)	53.36 (85.09)	53.70 (111.9)

Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 107.76 (90% CI 100.35 to 115.72)
Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Ratio Mean (%): 112.22 (90% CI 92.27 to 136.49)
Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 101.45 (90% CI 91.76 to 112.15)

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

Measure	Treatment A n = 101	Treatment B (Replicate 1) n = 97	Treatment B (Replicate 2) n = 99
Budesonide	2460 (63.25)	2398 (62.89)	2421 (78.43)
Glycopyrronium	25.11 (182.1)	20.34 (190.9)	34.58 (180.3)
Formoterol	36.47 (112.8)	35.68 (117.6)	35.83 (160.9)

Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 106.87 (90% CI 99.30 to 115.01)
Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 102.02 (90% CI 89.12 to 116.79)
Treatment A vs Treatment B (Replicate 1) vs Treatment B (Replicate 2): Geometric Mean Ratio (%): 107.76 (90% CI 94.91 to 122.36)

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening (Day -28 to Day -1) up to 55 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 103 (0%)	12 of 103 (11.7%)	0 of 103
Treatment B (Replicate 1)	0 of 105 (0%)	19 of 105 (18.1%)	0 of 105
Treatment B (Replicate 2)	0 of 104 (0%)	4 of 104 (3.8%)	0 of 104

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 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 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?

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 27 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 28 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 28 May 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?

Maximum Observed Plasma (Peak) Drug Concentration (Cmax ) (time frame: Pre-dose, 2 minutes, 5 minutes,10 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hours (h), 2 h, 4 h, 8 h, 12h and 24 hours post-dose on 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 NCT05477108, 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 28 Aug 2025.