HealthyPhase 1NCT06340581
A Study to Assess the Lung Exposure Bioequivalence 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
A Phase 1 study testing Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO and Treatment C: BGF MDI HFO in people with Healthy, run by AstraZeneca.
Trial summary
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a spacer. The secondary objective is to characterize BGF MDI HFO with and without a spacer. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO and Treatment C: BGF MDI HFO
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Oct 2024to 27 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating.
- Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2) inclusive and weigh at least 50 kilograms (kg).
- Have a FEV1 greater than or equal to (>=) 80 percentage (%).
- 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 severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2).
Who cannot join
- 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.
- 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.
- 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.
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- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results.
- Any clinically significant abnormal findings in physical examination or vital signs at screening, as judged by the investigator. Eg., Systolic blood pressure (BP) less than (<) 90 millimeters of Mercury (mmHg) or greater than or equal to (>=) 140 mmHg and diastolic BP < 50 mmHg or >=90 mmHg; Heart rate < 50 beats per minute (bpm) or > 90 bpm.
- Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
- Any positive result on screening for serum hepatitis B surface antigen (HBsAg) OR anti-hepatitis B core (HBc) antibody, indicative of hepatitis B, hepatitis C antibody, or human immunodeficiency virus (HIV).
- Positive reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2 prior to randomization.
- Participant has clinical signs and symptoms consistent with Coronavirus disease 2019 (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).
- 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.
- History of any respiratory disorders such as asthma, Chronic obstructive pulmonary disease (COPD), or idiopathic pulmonary fibrosis.
- Known or suspected history of drug abuse, as judged by the investigator.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days or 5 half-lives (whichever is longest) of the first administration of IMP in this study.
- Plasma donation within one 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 to drugs with a similar chemical structure or class to BGF or to its excipients, such as norflurane.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 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 at screening or 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 (intake of 20 to 600 times the recommended daily dose) and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.
- Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator. Excessive intake of alcohol defined as the regular consumption of more than 24 g of alcohol per day for men or 12 g of alcohol per day for women.
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate).
- Participants who have previously received BGF MDI HFO.
About this study
Official title: A Phase I, Randomized, Partial Double-blind, Single Dose, 3 Way Cross Over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared With BGF MDI HFA Using an AeroChamber Plus Flow Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a spacer. The secondary objective is to characterize BGF MDI HFO with and without a spacer.
Read the detailed description
This study is a Phase I, randomized, partial double-blind, single dose, single-center, 3-way cross over study to assess the pharmacokinetic (PK) and safety of BGF MDI in healthy participants (male or female).
The study will comprise:
- A Screening Period of up to 27 days prior to first dosing.
- Three treatment periods: Participants will be resident at the Clinical Unit from Day -1 until 24 hours after dosing with the final treatment.
- Follow-up: A final Follow-up Phone Call within 5 to 7 days after the last administration of BGF MDI in Treatment Period 3.
Participants will receive all 3 treatments as a single dose (4 inhalations) (Treatment A [BGF MDI HFA with AeroChamber Plus Flow-Vu spacer with charcoal, reference formulation], Treatment B [BGF MDI HFO with AeroChamber Plus Flow-Vu spacer with charcoal - test formulation], and Treatment C [BGF MDI HFO without spacer with charcoal]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
There will be a 3 to 7 days washout period between each dose administration.
- Conditions
- Healthy
- Being tested
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO, AeroChamber Plus Flow-Vu Spacer
- Keywords
- Ex-actuator, AeroChamber, Spacer, COPD with moderate to severe airflow obstruction, Long-acting beta2-agonist (LABA), Long-acting muscarinic antagonist (LAMA), Propellant, Next Generation Propellant (NGP), Inhaled Corticosteroid (ICS), Lung Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A: BGF MDI HFADrug
Participants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal.
Treatment B: BGF MDI HFODrug
Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal.
Treatment C: BGF MDI HFODrug
Participants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal.
AeroChamber Plus Flow-Vu SpacerDevice
Participants will receive 4 inhalations of BGF MDI HFA (treatment A) and BGF MDI HFO (Treatment B) as a single dose with AeroChamber Plus Flow-Vu spacer.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1: ABC | Experimental | Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFA with spacer (Treatment A), followed by BGF MDI HFO with spacer (Treatment B), and then BGF MDI HFO without spacer (Treatment C) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. Receives: Drug: Treatment A: BGF MDI HFA; Drug: Treatment B: BGF MDI HFO; Drug: Treatment C: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu Spacer |
| Treatment Sequence 2: ACB | Experimental | Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFA with spacer (Treatment A), followed by BGF MDI HFO without spacer (Treatment C), and then BGF MDI HFO with spacer (Treatment B) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. Receives: Drug: Treatment A: BGF MDI HFA; Drug: Treatment B: BGF MDI HFO; Drug: Treatment C: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu Spacer |
| Treatment Sequence 3: BAC | Experimental | Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO with spacer (Treatment B), followed by BGF MDI HFA with spacer (Treatment A), and then BGF MDI HFO without spacer (Treatment C) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. Receives: Drug: Treatment A: BGF MDI HFA; Drug: Treatment B: BGF MDI HFO; Drug: Treatment C: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu Spacer |
| Treatment Sequence 4: BCA | Experimental | Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO with spacer (Treatment B) followed by BGF MDI HFO without spacer (Treatment C), and then BGF MDI HFA with spacer (Treatment A) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. Receives: Drug: Treatment A: BGF MDI HFA; Drug: Treatment B: BGF MDI HFO; Drug: Treatment C: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu Spacer |
| Treatment Sequence 5: CAB | Experimental | Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO without spacer (Treatment C), followed by BGF MDI HFA with spacer (Treatment A), and then BGF MDI HFO with spacer (Treatment B) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. Receives: Drug: Treatment A: BGF MDI HFA; Drug: Treatment B: BGF MDI HFO; Drug: Treatment C: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu Spacer |
| Treatment Sequence 6: CBA | Experimental | Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO without spacer (Treatment C), followed by BGF MDI HFO with spacer (Treatment B), and then BGF MDI HFA with spacer (Treatment A) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. Receives: Drug: Treatment A: BGF MDI HFA; Drug: Treatment B: BGF MDI HFO; Drug: Treatment C: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI
The bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer compared with BGF MDI HFA with a spacer will be assessed.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Maximum Observed Concentration (Cmax) of BGF MDI
The bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer compared with BGF MDI HFA with a spacer will be assessed.
Measured: 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)
The relative lung bioavailability of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer versus BGF MDI HFO without a spacer will be assessed.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Maximum Observed Concentration (Cmax)
The relative lung bioavailability of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer versus BGF MDI HFO without a spacer will be assessed.
Measured: 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)
The lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Time to Reach Maximum Observed Concentration (tmax)
The lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant (λz)
The lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
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 (t1/2λz)
The lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
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 lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
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 lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Apparent Volume of Distribution at Steady State Following Extravascular Administration (Vz/F)
The lung exposure PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer will be assessed.
Measured: 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 (with and without spacer) and BGF MDI HFA with a spacer, in healthy participants will be evaluated.
Measured: From Baseline up to 48 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start17 Oct 2024 (estimated)
- Primary completion27 Feb 2025 (estimated)
- Study completion27 Feb 2025 (estimated)
Why it stopped: Study no longer required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340581
- Sponsor's protocol ID
- D5985C00009
- Other IDs
- 2023-509914-12, 2023
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2024
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- 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 Vivli.org. All requests 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Partial Double-blind, Single Dose, 3 Way Cross Over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared With BGF MDI HFA Using an AeroChamber Plus Flow Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer
- ClinicalTrials.gov ID
- NCT06340581
- Acronym / sponsor ID
- D5985C00009
- Conditions
- Healthy
- Keywords
- Ex-actuator, AeroChamber, Spacer, COPD with moderate to severe airflow obstruction, Long-acting beta2-agonist (LABA), Long-acting muscarinic antagonist (LAMA), Propellant, Next Generation Propellant (NGP)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study no longer required.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 17 Oct 2024 (estimated)
- Primary completion
- 27 Feb 2025 (estimated)
- Study completion
- 27 Feb 2025 (estimated)
- First posted
- 1 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to demonstrate the equivalence of budesonide, glycopyrronium, formoterol (BGF) metered dose inhaler (MDI) hydrofluoroolefin (HFO) with a spacer to BGF MDI hydrofluoroalkane (HFA) with a spacer. The secondary objective is to characterize BGF MDI HFO with and without a spacer.
Detailed description
This study is a Phase I, randomized, partial double-blind, single dose, single-center, 3-way cross over study to assess the pharmacokinetic (PK) and safety of BGF MDI in healthy participants (male or female).
The study will comprise:
- A Screening Period of up to 27 days prior to first dosing.
- Three treatment periods: Participants will be resident at the Clinical Unit from Day -1 until 24 hours after dosing with the final treatment.
- Follow-up: A final Follow-up Phone Call within 5 to 7 days after the last administration of BGF MDI in Treatment Period 3.
Participants will receive all 3 treatments as a single dose (4 inhalations) (Treatment A [BGF MDI HFA with AeroChamber Plus Flow-Vu spacer with charcoal, reference formulation], Treatment B [BGF MDI HFO with AeroChamber Plus Flow-Vu spacer with charcoal - test formulation], and Treatment C [BGF MDI HFO without spacer with charcoal]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
There will be a 3 to 7 days washout period between each dose administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1: ABC | Experimental | Drug: Treatment A: BGF MDI HFA, Drug: Treatment B: BGF MDI HFO, Drug: Treatment C: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu SpacerParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFA with spacer (Treatment A), followed by BGF MDI HFO with spacer (Treatment B), and then BGF MDI HFO without spacer (Treatment C) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. |
| Treatment Sequence 2: ACB | Experimental | Drug: Treatment A: BGF MDI HFA, Drug: Treatment B: BGF MDI HFO, Drug: Treatment C: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu SpacerParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFA with spacer (Treatment A), followed by BGF MDI HFO without spacer (Treatment C), and then BGF MDI HFO with spacer (Treatment B) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. |
| Treatment Sequence 3: BAC | Experimental | Drug: Treatment A: BGF MDI HFA, Drug: Treatment B: BGF MDI HFO, Drug: Treatment C: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu SpacerParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO with spacer (Treatment B), followed by BGF MDI HFA with spacer (Treatment A), and then BGF MDI HFO without spacer (Treatment C) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. |
| Treatment Sequence 4: BCA | Experimental | Drug: Treatment A: BGF MDI HFA, Drug: Treatment B: BGF MDI HFO, Drug: Treatment C: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu SpacerParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO with spacer (Treatment B) followed by BGF MDI HFO without spacer (Treatment C), and then BGF MDI HFA with spacer (Treatment A) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. |
| Treatment Sequence 5: CAB | Experimental | Drug: Treatment A: BGF MDI HFA, Drug: Treatment B: BGF MDI HFO, Drug: Treatment C: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu SpacerParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO without spacer (Treatment C), followed by BGF MDI HFA with spacer (Treatment A), and then BGF MDI HFO with spacer (Treatment B) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. |
| Treatment Sequence 6: CBA | Experimental | Drug: Treatment A: BGF MDI HFA, Drug: Treatment B: BGF MDI HFO, Drug: Treatment C: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu SpacerParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive single-dose treatments of BGF MDI HFO without spacer (Treatment C), followed by BGF MDI HFO with spacer (Treatment B), and then BGF MDI HFA with spacer (Treatment A) in 3 treatment periods with single dose (4 puffs) on Day 1 of all treatment periods. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating.
- Have a body mass index (BMI) between 18 and 30 kilograms per meter square (kg/m^2) inclusive and weigh at least 50 kilograms (kg).
- Have a FEV1 greater than or equal to (>=) 80 percentage (%).
- 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 severe acute respiratory syndrome coronavirus type 2 (SARS CoV-2).
Key exclusion criteria (26 listed)
- 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.
- 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.
- 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 HFAParticipants will receive 4 oral inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. | Drug | Treatment Sequence 1: ABC, Treatment Sequence 2: ACB, Treatment Sequence 3: BAC, Treatment Sequence 4: BCA, Treatment Sequence 5: CAB, Treatment Sequence 6: CBA |
| Treatment B: BGF MDI HFOParticipants will receive 4 oral inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer with charcoal. | Drug | Treatment Sequence 1: ABC, Treatment Sequence 2: ACB, Treatment Sequence 3: BAC, Treatment Sequence 4: BCA, Treatment Sequence 5: CAB, Treatment Sequence 6: CBA |
| Treatment C: BGF MDI HFOParticipants will receive 4 oral inhalations of BGF MDI HFO as a single dose without spacer with charcoal. | Drug | Treatment Sequence 1: ABC, Treatment Sequence 2: ACB, Treatment Sequence 3: BAC, Treatment Sequence 4: BCA, Treatment Sequence 5: CAB, Treatment Sequence 6: CBA |
| AeroChamber Plus Flow-Vu SpacerParticipants will receive 4 inhalations of BGF MDI HFA (treatment A) and BGF MDI HFO (Treatment B) as a single dose with AeroChamber Plus Flow-Vu spacer. | Device | Treatment Sequence 1: ABC, Treatment Sequence 2: ACB, Treatment Sequence 3: BAC, Treatment Sequence 4: BCA, Treatment Sequence 5: CAB, Treatment Sequence 6: CBA |
Primary outcome
Area Under the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
The bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer compared with BGF MDI HFA with a spacer will be assessed.
Maximum Observed Concentration (Cmax) of BGF MDI
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
The bioequivalence of the lung exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer compared with BGF MDI HFA with a spacer will be assessed.
10 secondary outcomes
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)
Maximum Observed Concentration (Cmax)
Time frame: 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)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Time to Reach Maximum Observed Concentration (tmax)
Time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant (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 (t1/2λz)
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)
Apparent Volume of Distribution at Steady State Following Extravascular Administration (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
Time frame: From Baseline up to 48 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- 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 Vivli.org. All requests 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 approved.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO and Treatment C: BGF MDI HFO in people with Healthy, run by AstraZeneca.
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 5 inclusion and 26 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: withdrawn, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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 the Plasma Concentration-curve from Zero to the Last Quantifiable Concentration (AUClast) of BGF MDI (time frame: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2025.