Healthy ParticipantsPhase 1NCT06723756
A Study to Investigate the Exposure of Budesonide, Glycopyrronium, and Formoterol (BGF) Delivered by Hydrofluoroolefin (HFO) Propellant Metered Dose Inhaler (MDI) Compared to a Hydrofluoroalkane (HFA) Propellant MDI in Healthy Adults
A Phase 1 study testing Treatment A: BGF MDI HFO and Treatment B: BGF MDI HFA in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- 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
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2025to 1 Jun 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
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
- Participants must have a forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value (based on age, height, ethnicity and gender at birth) and an FEV1/forced vital capacity (FEV1/FVC) > 70% at the Screening Visit. FEV1/FVC can be reported as ratio ie, 0.7 or a percentage ie, 70%.
- Participants must demonstrate proper inhalation technique and have the ability to properly use an MDI device after training.
Who cannot join
- History of any clinically significant disease that put the participant at risk of participation.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, history of narrow angle glaucoma not adequately treated, or bladder neck obstruction/urinary retention.
- Unresectable cancer that has not been in complete remission for at least 5 years.
- Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis results, or vital signs at Screening.
- Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at Screening.
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- Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) antibodies.
- History of any respiratory disorders such as asthma, COPD, or idiopathic pulmonary fibrosis.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
- Known or suspected history of alcohol or drug abuse as judged by the Investigator.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes).
- Excessive intake of caffeine-containing drinks or food.
Trial locations and contacts
1 site in 1 country.
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 in Healthy Adult Participants
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.
Read the detailed description
This is a Phase I, randomized, double-blind, single-dose, single-site, three way cross-over study to assess the pharmacokinetic (PK) and safety of BGF MDI with HFO propellant compared with BGF MDI with HFA propellant in healthy participants (male or female).
The study will comprise of:
- A Screening period of up to 27 days;
- Three Treatment periods: Participants will receive a single dose of the study intervention on three separate occasions (Period 1, Period 2 and Period 3), with the final dose on Day 2 of Treatment Period 3, and a washout period of 5 to 7 days between administration of each dose;
- A final Safety Follow-up within 5 to 7 days after the last administration of the study intervention in Treatment Period 3.
Participants will receive all the treatments as a single dose (2 inhalations) (Treatment A [BGF MDI HFO - test formulation], and Treatment B [BGF MDI HFA - reference formulation]) in one of the 3 possible treatment sequences: ABB, BAB, or BBA. Each participant will be involved in the study for up to 52 days.
- Conditions
- Healthy Participants
- Being tested
- Treatment A: BGF MDI HFO, Treatment B: BGF MDI HFA
- Keywords
- Asthma, Propellant, Metered dose inhaler
- Medical subject headings
- Asthma
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/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFO
Participants will receive 2 inhalations of BGF MDI HFO (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 1 Treatment period.
Treatment B: BGF MDI HFADrug
Also called Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFA
Participants will receive 2 inhalations of BGF MDI HFA (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 2 Treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| BGF MDI HFO | Experimental | Participants will receive single doses (2 inhalations as a single dose) of test formulation BGF MDI HFO Receives: Drug: Treatment A: BGF MDI HFO |
| BGF MDI HFA | Active comparator | Participants will receive single doses (2 inhalations as a single dose) of reference formulation BGF MDI HFA Receives: 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 concentration curve from time 0 to the last quantifiable concentration (AUClast)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Maximum observed drug concentration (Cmax)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Secondary outcomes (8)
Area under concentration time curve from time 0 to infinity (AUCinf)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Extrapolated area under the curve from time of last quantifiable concentration (tlast) to infinity, expressed as percentage of AUCinf (AUCextr)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Time to reach maximum observed concentration (tmax)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Terminal rate constant (λz)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Terminal elimination half-life (t1/2λz)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Apparent total body clearance (CL/F)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Apparent volume of distribution based on the terminal phase (Vz/F)
Measured: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start23 Jan 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- 105 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
- NCT06723756
- Sponsor's protocol ID
- D598AC00001
- Status last verified
- Jun 2025
- First submitted
- 4 Dec 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- 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 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 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 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06723756
- Acronym / sponsor ID
- D598AC00001
- Conditions
- Healthy Participants
- Keywords
- Asthma, Propellant, Metered dose inhaler
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 9 Dec 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.
This study aims to assess the bioequivalence of the total systemic exposure and safety of budesonide, glycopyrronium, and formoterol (160/14.4/4.8 µg/actuation) when administered as BGF MDI HFO compared with BGF MDI HFA in healthy participants.
Detailed description
This is a Phase I, randomized, double-blind, single-dose, single-site, three way cross-over study to assess the pharmacokinetic (PK) and safety of BGF MDI with HFO propellant compared with BGF MDI with HFA propellant in healthy participants (male or female).
The study will comprise of:
- A Screening period of up to 27 days;
- Three Treatment periods: Participants will receive a single dose of the study intervention on three separate occasions (Period 1, Period 2 and Period 3), with the final dose on Day 2 of Treatment Period 3, and a washout period of 5 to 7 days between administration of each dose;
- A final Safety Follow-up within 5 to 7 days after the last administration of the study intervention in Treatment Period 3.
Participants will receive all the treatments as a single dose (2 inhalations) (Treatment A [BGF MDI HFO - test formulation], and Treatment B [BGF MDI HFA - reference formulation]) in one of the 3 possible treatment sequences: ABB, BAB, or BBA. Each participant will be involved in the study for up to 52 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BGF MDI HFO | Experimental | Drug: Treatment A: BGF MDI HFOParticipants will receive single doses (2 inhalations as a single dose) of test formulation BGF MDI HFO |
| BGF MDI HFA | Active comparator | Drug: Treatment B: BGF MDI HFAParticipants will receive single doses (2 inhalations as a single dose) of reference formulation BGF MDI HFA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy participants with suitable veins for cannulation or repeated venipuncture.
- All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- Females of non-childbearing potential must be confirmed at the Screening Visit.
- Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 120 kg inclusive.
Key exclusion criteria (12 listed)
- History of any clinically significant disease that put the participant at risk of participation.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, history of narrow angle glaucoma not adequately treated, or bladder neck obstruction/urinary retention.
- Unresectable cancer that has not been in complete remission for at least 5 years.
- Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis results, or vital signs at Screening.
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/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFOParticipants will receive 2 inhalations of BGF MDI HFO (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 1 Treatment period. | Drug | BGF MDI HFO |
| Treatment B: BGF MDI HFAAlso: Budesonide/glycopyrronium/formoterol fumarate pressurized inhalation suspension, HFAParticipants will receive 2 inhalations of BGF MDI HFA (Budesonide/glycopyrronium/fomoterol fumarate pressurized inhalation suspension 160/14.4/4.8 μg per actuation) as a single dose via oral inhalation administered during 2 Treatment periods. | Drug | BGF MDI HFA |
Primary outcome
Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Maximum observed drug concentration (Cmax)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
8 secondary outcomes
Area under concentration time curve from time 0 to infinity (AUCinf)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Extrapolated area under the curve from time of last quantifiable concentration (tlast) to infinity, expressed as percentage of AUCinf (AUCextr)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Time to reach maximum observed concentration (tmax)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Terminal rate constant (λz)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Terminal elimination half-life (t1/2λz)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity (MRTinf)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Apparent total body clearance (CL/F)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Thank You CardLink 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 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 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 Healthy Participants, 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 7 inclusion and 12 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 5 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 concentration curve from time 0 to the last quantifiable concentration (AUClast) (time frame: Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose, and 1, 2, 4, 8, 12 and 24 hours post-dose). 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 5 Jun 2025.