Chronic Obstructive Pulmonary DiseasePhase 1NCT06297668
A Study to Assess the Pharmacokinetics and Safety of Budesonide, Glycopyrronium, & Formoterol (BGF) Metered Dose Inhaler (MDI) With a Next-Generation Propellant (NGP) With a Spacer, BGF MDI Hydrofluoroalkane (HFA) With a Spacer, as Well as BGF MDI NGP Without a Spacer
A Phase 1 study testing Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO and Treatment C: BGF MDI HFO in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Germany.
Trial summary
This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer. 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 HFA, Treatment B: BGF MDI HFO and Treatment C: BGF MDI HFO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteGermany
- Study dates
- 29 Apr 2024to 11 Jun 2024
- 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, confirmed at screening.
- Women of childbearing potential who are sexually active with a non-sterilized male partner, must use 1 highly effective form of birth control from enrolment throughout the study and until at least 14 days after last dose of IMP. Women should be stable on their chosen method of birth control for at least 1 month from enrolment.
- Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
- Have a Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/forced vital capacity> 70% regarding age, height, and ethnicity at screening.
- Demonstrate basic understanding of how to use an MDI device with and without a spacer after receiving training.
- Participants should be fully/sufficiently vaccinated as per local definitions against SARS-CoV-2 (in combination with confirmed past infections with SARS-CoV-2).
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.
- Participants who have previously received BGF MDI HFO.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to BGF or to its excipients, such as norflurane.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
- History of narrow angle glaucoma or change in vision that may be relevant.
Show all 23Show fewer
- History of symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, which in the opinion of the investigator, is clinically significant.
- Unresectable cancer that has not been in complete remission for at least 5 years.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at screening as judged by the investigator.
- Any clinically significant abnormal findings in physical examination or vital signs at screening, as judged by the investigator.
- Any clinically significant abnormalities on 12-lead ECG at screening, as judged by the investigator.
- Any positive result on screening for serum hepatitis B surface antigen or anti-hepatitis B core antibody, indicative of hepatitis B, hepatitis C antibody, or human immunodeficiency virus.
- Positive reverse transcription polymerase chain reaction test for SARS-CoV-2 prior to randomization.
- Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnea, sore throat, fatigue, new smell or taste disorder or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
- Participant who had severe course of COVID-19 (ie, hospitalization, extracorporeal membrane oxygenation, or mechanically ventilated).
- 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, COPD, or idiopathic pulmonary fibrosis.
- Known or suspected history of drug abuse.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
- 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.
- Excessive intake of caffeine-containing drinks or food (eg, coffee, tea, chocolate).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Partial Double-blind, Single-dose, 3-Way Cross-over Study to Assess the Total Systemic Exposure 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 Total Systemic Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer
This study aims to assess the effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.
Read the detailed description
This is a Phase I, randomized, partial double-blind, single dose, three way cross-over study to assess the effect of total systemic exposure of BGF when administered as BGF MDI HFO compared with BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to compare the Total Systemic Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer in healthy participants (male or female).
The study will comprise of:
- 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, with a washout period of 3 to 7 days between each dose administration.
- 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 - reference formulation], Treatment B [BGF MDI HFO with AeroChamber Plus Flow-Vu spacer - test formulation], and Treatment C [BGF MDI HFO without spacer]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Treatment A: BGF MDI HFA, Treatment B: BGF MDI HFO, Treatment C: BGF MDI HFO, AeroChamber Plus Flow-Vu spacer
- Keywords
- Metered Dose Inhalers (MDI), Propellant, Next Generation Propellant (NGP), Inhaled Corticosteroid (ICS), Long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA), Total Systemic exposure, Healthy participants
- 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 HFADrug
Participants will receive 4 inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer.
Treatment B: BGF MDI HFODrug
Participants will receive 4 inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer.
Treatment C: BGF MDI HFODrug
Participants will receive 4 inhalations of BGF MDI HFO as a single dose without spacer.
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 spacer.
| Study group | Role | What they receive |
|---|---|---|
| BGF MDI HFA | Active comparator | Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroalkane with AeroChamber Plus Flow-Vu spacer-reference formulation Receives: Drug: Treatment A: BGF MDI HFA; Device: AeroChamber Plus Flow-Vu spacer |
| BGF MDI HFO with spacer | Active comparator | Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin with AeroChamber Plus Flow-Vu spacer-test formulation Receives: Drug: Treatment B: BGF MDI HFO; Device: AeroChamber Plus Flow-Vu spacer |
| BGF MDI HFO without spacer | Active comparator | Budesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin without AeroChamber Plus Flow-Vu spacer Receives: Drug: Treatment C: BGF MDI HFO |
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
To assess that the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with AeroChamber Plus Flow-Vu spacer does not exceed that with BGF MDI HFA with AeroChamber Plus Flow-Vu spacer.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Maximum Observed Concentration (Cmax) of BGF MDI
To assess that the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with AeroChamber Plus Flow-Vu spacer does not exceed that with BGF MDI HFA with AeroChamber Plus Flow-Vu spacer.
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)
To assess the relative bioavailability of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer versus BGF MDI HFO without a spacer.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Maximum Observed Concentration (Cmax)
To assess the relative bioavailability of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with a spacer versus BGF MDI HFO without a spacer.
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)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Time to Reach Maximum Observed Concentration (tmax)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Terminal Rate Constant (λz)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
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)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
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)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
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)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
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)
To characterize the PK parameters of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO (with and without spacer) and BGF MDI HFA with a spacer.
Measured: Day 1 and Day 2 of each treatment period (each treatment period is of 2 days)
Number of Participants with Adverse Events
To assess 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.
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 posted7 Mar 2024
- Study start29 Apr 2024
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 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
- NCT06297668
- Sponsor's protocol ID
- D5985C00008
- Other IDs
- 2023-504089-43-00, 2023
- Status last verified
- Aug 2025
- First submitted
- 1 Mar 2024
- Last updated
- 13 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 13 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 Total Systemic Exposure 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 Total Systemic Exposure of BGF MDI HFO With a Spacer to BGF MDI HFO Without a Spacer
- ClinicalTrials.gov ID
- NCT06297668
- Acronym / sponsor ID
- D5985C00008
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Metered Dose Inhalers (MDI), Propellant, Next Generation Propellant (NGP), Inhaled Corticosteroid (ICS), Long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA), Total Systemic exposure, Healthy participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 29 Apr 2024 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 7 Mar 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 effect on total systemic exposure and to characterize exposure BGF MDI HFO with a spacer compared to without a spacer; also, to demonstrate that total systemic exposure of BGF when administered as MDI HFO with a spacer is not greater than BGF MDI HFA with a spacer.
Detailed description
This is a Phase I, randomized, partial double-blind, single dose, three way cross-over study to assess the effect of total systemic exposure of BGF when administered as BGF MDI HFO compared with BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to compare the Total Systemic Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer in healthy participants (male or female).
The study will comprise of:
- 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, with a washout period of 3 to 7 days between each dose administration.
- 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 - reference formulation], Treatment B [BGF MDI HFO with AeroChamber Plus Flow-Vu spacer - test formulation], and Treatment C [BGF MDI HFO without spacer]) (1 treatment per treatment period) in one of 6 possible treatment sequences; ABC, ACB, BAC, BCA, CAB, or CBA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGF MDI HFA | Active comparator | Drug: Treatment A: BGF MDI HFA, Device: AeroChamber Plus Flow-Vu spacerBudesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroalkane with AeroChamber Plus Flow-Vu spacer-reference formulation |
| BGF MDI HFO with spacer | Active comparator | Drug: Treatment B: BGF MDI HFO, Device: AeroChamber Plus Flow-Vu spacerBudesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin with AeroChamber Plus Flow-Vu spacer-test formulation |
| BGF MDI HFO without spacer | Active comparator | Drug: Treatment C: BGF MDI HFOBudesonide/Glycoperronium/formoterol fumarate pressurised inhalation suspension 160/7.2/4.8 μg per actuation, hydrofluoroolefin without AeroChamber Plus Flow-Vu spacer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Females must have a negative pregnancy test at screening and on admission to the Clinical Unit, must not be lactating, confirmed at screening.
- Women of childbearing potential who are sexually active with a non-sterilized male partner, must use 1 highly effective form of birth control from enrolment throughout the study and until at least 14 days after last dose of IMP. Women should be stable on their chosen method of birth control for at least 1 month from enrolment.
- Have a body mass index between 18 and 30 kg/m2 inclusive and weigh at least 50 kg.
- Have a Forced expiratory volume in the first second (FEV1) ≥ 80% of the predicted normal value and an FEV1/forced vital capacity> 70% regarding age, height, and ethnicity at screening.
- Demonstrate basic understanding of how to use an MDI device with and without a spacer after receiving training.
Key exclusion criteria (23 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.
- Participants who have previously received BGF MDI HFO.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to BGF or to its excipients, such as norflurane.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
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 inhalations of BGF MDI HFA as a single dose with AeroChamber Plus Flow-Vu spacer. | Drug | BGF MDI HFA |
| Treatment B: BGF MDI HFOParticipants will receive 4 inhalations of BGF MDI HFO as a single dose with AeroChamber Plus Flow-Vu spacer. | Drug | BGF MDI HFO with spacer |
| Treatment C: BGF MDI HFOParticipants will receive 4 inhalations of BGF MDI HFO as a single dose without spacer. | Drug | BGF MDI HFO without spacer |
| 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 spacer. | Device | BGF MDI HFA, BGF MDI HFO with spacer |
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)
To assess that the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with AeroChamber Plus Flow-Vu spacer does not exceed that with BGF MDI HFA with AeroChamber Plus Flow-Vu spacer.
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)
To assess that the total systemic exposure of budesonide, glycopyrronium, and formoterol administered as BGF MDI HFO with AeroChamber Plus Flow-Vu spacer does not exceed that with BGF MDI HFA with AeroChamber Plus Flow-Vu spacer.
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 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 13 Aug 2025.
- 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 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.
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 HFA, Treatment B: BGF MDI HFO and Treatment C: BGF MDI HFO in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 1 site in Germany.
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 13 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 Germany. 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 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 13 Aug 2025.