Chronic Obstructive Pulmonary Disease (COPD)Phase 1NCT04600505

A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol

A Phase 1 study testing Treatment A, Treatment B and Treatment C in people with Chronic Obstructive Pulmonary Disease (COPD), 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

Search all trials

Trial summary

The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A [test]), Propellant 2 (Treatment B [test]) and Hydrofluoroalkane (HFA) (Treatment C… Read more about this study

Who is it for?: Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Chronic Obstructive Pulmonary Disease (COPD)
What is being tested?: Treatment A, Treatment B and Treatment C
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 47 participants
Where: 1 siteUnited States
Study dates: 19 Oct 2020to 17 May 2021
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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed and dated, written informed consent prior to any study specific procedures.
Non-smoking male participants with suitable veins for cannulation or repeated venipuncture.
Participants must agree to follow the reproductive restrictions.
Have a body mass index between 18 and 30 kg/m^2 and weigh at least 50 kg and no more than 100 kg.
Participants must have a forced expiratory volume in one second ≥ 80% of the predicted value regarding age, height, and ethnicity at the screening visit.

Who cannot join

History or current evidence of a clinically significant (CS) disease or disorder (including but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary).
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 CS illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Narrow angle glaucoma not adequately treated. All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non-selective β-blockers.
Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the principal investigator (PI), is CS.
Any cancer except squamous cell and basal cell carcinomas of the skin are allowed in the study.

Show all 35Show fewer

Any CS abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and/or admission to the Clinical Unit:
Systolic blood pressure (BP) < 90 mmHg or > 140 mmHg.
Diastolic BP < 50 mmHg or > 90 mmHg.
Heart rate < 45 or > 85 bpm.
Any CS abnormal findings in vital signs, after 5 minutes supine rest, at screening and/or Day -1 of each Treatment Period, as judged by the PI.
Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG as considered by the PI.
Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.
Known or suspected history of drug abuse.
Participant has a positive reverse transcription polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to randomization.
Participant has clinical signs and symptoms consistent with SARS-CoV-2 infection (e.g., fever, dry cough, dyspnea, sore throat, fatigue, or laboratory confirmed acute infection with SARS-CoV-2).
Participant who had severe course of coronavirus disease 2019 (COVID-19).
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.
Recent (within 14 days prior to admission to the Clinical Unit) visit to a healthcare facility where COVID-19 patients are being treated.
Has a current occupation that involves routine exposure to potential COVID-19 patients or sources of SARS-CoV-2 infection.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study.
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 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, herbal remedies, megadose vitamins 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 abuse or excessive intake of alcohol.
Participants who have previously received BGF.
Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.
Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
History of any respiratory disorders such as asthma, COPD or idiopathic pulmonary fibrosis.
Participants who cannot use an inhaler appropriately.
Participants who cannot communicate reliably with the PI.
Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg vector, lipid nanoparticle) less than 7 days prior to the date of randomization (from last vaccination or booster dose).

Trial locations and contacts

1 site in 1 country.

United States1 site

Research Site
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Randomized, Single Blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared With BGF MDI HFA in Healthy Subjects

Read the detailed description

The study will comprise:

Screening period: up to 28 days prior to first dosing;
Three treatment periods of maximum 3 days each: participants will be resident from the morning of the day before the first dosing with BGF MDI (Day -1) in Treatment Period 1, throughout all treatment and washout periods up to discharge on Day 2 of Treatment Period 3;
Follow-up: within 3 to 7 days after the last administration of BGF MDI. There will be a washout period of 3 to 7 days between each dose.

Each participant will receive 3 single-dose treatments of BGF MDI (1 dose Propellant 1 [Treatment A]; 1 dose Propellant 2 [Treatment B] and 1 dose HFA [Treatment C]), following an overnight fast of at least 8 hours. Each participant will be involved in the study for up to 53 days.

Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Being tested: Treatment A, Treatment B, Treatment C
Keywords: Budesonide, Glycopyrronium, Formoterol, Hydrofluoroalkane, Metered dose inhaler
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 ADrug
Also called BGF MDI Propellant 1
Participants will receive 2 inhalations of BGF MDI with propellant 1.
Treatment BDrug
Also called BGF MDI Propellant 2
Participants will receive 2 inhalations of BGF MDI with propellant 2.
Treatment CDrug
Also called BGF MDI HFA
Participants will receive 2 inhalations of BGF MDI with HFA propellant.

Study groups in NCT04600505
Study group	Role	What they receive
Treatment Sequence ABC	Experimental	Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment B; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Treatment Sequence BCA	Experimental	Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment C; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Treatment Sequence CAB	Experimental	Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment A; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Treatment Sequence ACB	Experimental	Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment C; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Treatment Sequence BAC	Experimental	Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment A; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C
Treatment Sequence CBA	Experimental	Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment B; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods. Receives: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

What is being measured

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

Maximum Observed Concentration (Cmax) of BGF MDI
Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by 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
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI
Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by 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
Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI
Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by 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

Secondary outcomes (5)

Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI
Assessment of tmax of BGF when administered as 3 different propellant formulations.
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 (t½λz) of BGF MDI
Assessment of t½λz of BGF when administered as 3 different propellant formulations.
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 of Drug After Extravascular Administration (CL/F) of BGF MDI
Assessment of CL/F of BGF when administered as 3 different propellant formulations.
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 During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI
Assessment of Vz/F of BGF when administered as 3 different propellant formulations.
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
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Assessment of the safety and tolerability of a combination of BGF when administered as single doses in 3 different propellant formulations in healthy participants.
Measured: Screening, Day -1 until Follow-up visit, up to 53 days

Timeline

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

19 Oct 202017 May 2021

First posted23 Oct 2020
Study start19 Oct 2020
Primary completion17 May 2021
Study completion17 May 2021

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 Disease (COPD)Studies 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: Single blind
Who is masked: Participant
Enrolment: 47 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04600505
Sponsor's protocol ID: D5985C00001
Status last verified: Apr 2022
First submitted: 19 Oct 2020
Last updated: 23 Jan 2023
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 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.

Publications

Aurivillius M, Bednarczyk A, Kokot M, Madriaga J, Mei J, Collison K, Surujbally R, Archbell J, Joshi V, Gillen M. Relative bioavailability of budesonide/glycopyrrolate/formoterol fumarate triple therapy delivered using next generation propellants with low global warming potential. Pulm Pharmacol Ther. 2023 Dec;83:102245. doi: 10.1016/j.pupt.2023.102245. Epub 2023 Aug 20.
PubMed 37607661

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 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single Blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared With BGF MDI HFA in Healthy Subjects
ClinicalTrials.gov ID: NCT04600505
Acronym / sponsor ID: D5985C00001
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Budesonide, Glycopyrronium, Formoterol, Hydrofluoroalkane, Metered dose inhaler
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 47 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: 19 Oct 2020 (actual)
Primary completion: 17 May 2021 (actual)
Study completion: 17 May 2021 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 23 Jan 2023

Clinical summary

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

Detailed description

The study will comprise:

Screening period: up to 28 days prior to first dosing;
Three treatment periods of maximum 3 days each: participants will be resident from the morning of the day before the first dosing with BGF MDI (Day -1) in Treatment Period 1, throughout all treatment and washout periods up to discharge on Day 2 of Treatment Period 3;
Follow-up: within 3 to 7 days after the last administration of BGF MDI. There will be a washout period of 3 to 7 days between each dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Treatment Sequence ABC	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment B; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods.
Treatment Sequence BCA	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment C; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods.
Treatment Sequence CAB	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment A; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods.
Treatment Sequence ACB	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment C; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods.
Treatment Sequence BAC	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment A; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods.
Treatment Sequence CBA	Experimental	Drug: Treatment A, Drug: Treatment B, Drug: Treatment CParticipants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment B; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods.

Who may qualify

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

Key inclusion criteria (5 listed)

Provision of signed and dated, written informed consent prior to any study specific procedures.
Non-smoking male participants with suitable veins for cannulation or repeated venipuncture.
Participants must agree to follow the reproductive restrictions.
Have a body mass index between 18 and 30 kg/m^2 and weigh at least 50 kg and no more than 100 kg.
Participants must have a forced expiratory volume in one second ≥ 80% of the predicted value regarding age, height, and ethnicity at the screening visit.

Key exclusion criteria (35 listed)

History or current evidence of a clinically significant (CS) disease or disorder (including but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary).
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 CS illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).
Narrow angle glaucoma not adequately treated. All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non-selective β-blockers.
Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the principal investigator (PI), is CS.

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 AAlso: BGF MDI Propellant 1Participants will receive 2 inhalations of BGF MDI with propellant 1.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Treatment BAlso: BGF MDI Propellant 2Participants will receive 2 inhalations of BGF MDI with propellant 2.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA
Treatment CAlso: BGF MDI HFAParticipants will receive 2 inhalations of BGF MDI with HFA propellant.	Drug	Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA

Primary outcome

Maximum Observed Concentration (Cmax) of BGF MDI
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
Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by Cmax.
Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI
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
Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUCinf.
Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI
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
Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUClast.

5 secondary outcomes

Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI
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 (t½λz) of BGF MDI
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 of Drug After Extravascular Administration (CL/F) of BGF MDI
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 During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI
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
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events
Time frame: Screening, Day -1 until Follow-up visit, up to 53 days

Results and safety

Results posted to the registry on 23 Jan 2023, 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 ABC	8	8
Treatment Sequence BCA	8	8
Treatment Sequence CAB	8	8
Treatment Sequence ACB	8	8
Treatment Sequence BAC	7	7
Treatment Sequence CBA	8	8

Primary outcome: Maximum Observed Concentration (Cmax) of BGF MDI

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. Geometric mean (Geometric Coefficient of Variation). Unit: pg/mL

Measure	Treatment A n = 24	Treatment B n = 22	Treatment C n = 23
Budesonide	552.2 (54.74)	483.2 (48.43)	489.4 (61.61)
Glycopyrronium	11.74 (72.16)	10.19 (58.42)	10.76 (70.78)
Formoterol	12.70 (50.52)	11.68 (47.22)	11.48 (52.95)

Treatment A vs Treatment C: Geometric mean Ratio (%): 111.7 (90% CI 91.01 to 137.1)
Treatment B vs Treatment C: Geometric mean Ratio (%): 98.78 (90% CI 78.67 to 124.0)
Treatment A vs Treatment C: Geometric mean Ratio (%): 108.3 (90% CI 85.50 to 137.3)

Population analysed: The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.

Primary outcome: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI

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. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	Treatment A n = 24	Treatment B n = 22	Treatment C n = 21
Budesonide	2454 (36.76)	2262 (32.27)	2314 (45.60)
Glycopyrronium	30.32 (39.74)	27.23 (30.67)	NA (NA)
Formoterol	93.68 (35.71)	115.1 (30.99)	92.84 (30.45)

Treatment A vs Treatment C: Geometric mean Ratio (%): 104.7 (90% CI 91.95 to 119.2)
Treatment B vs Treatment C: Geometric mean Ratio (%): 98.03 (90% CI 83.33 to 115.3)
Treatment A vs Treatment C: Geometric mean Ratio (%): 96.00 (90% CI 70.33 to 131.0)

Primary outcome: Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI

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. Geometric mean (Geometric Coefficient of Variation). Unit: h*pg/mL

Measure	Treatment A n = 24	Treatment B n = 22	Treatment C n = 23
Budesonide	2391 (36.77)	2197 (32.81)	2232 (44.14)
Glycopyrronium	29.87 (88.09)	28.63 (53.90)	29.20 (82.24)
Formoterol	66.17 (50.54)	74.34 (41.35)	67.82 (55.58)

Treatment A vs Treatment C: Geometric mean Ratio (%): 107.3 (90% CI 94.53 to 121.9)
Treatment B vs Treatment C: Geometric mean Ratio (%): 98.80 (90% CI 84.59 to 115.4)
Treatment A vs Treatment C: Geometric mean Ratio (%): 106.1 (90% CI 86.18 to 130.6)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Screening, Day -1 until Follow-up visit, up to 53 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A	0 of 47 (0%)	9 of 47 (19.1%)	0 of 47
Treatment B	0 of 47 (0%)	10 of 47 (21.3%)	0 of 47
Treatment C	0 of 47 (0%)	10 of 47 (21.3%)	0 of 47

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37607661Aurivillius M, Bednarczyk A, Kokot M, Madriaga J, Mei J, Collison K, Surujbally R, Archbell J, Joshi V, Gillen M. Relative bioavailability of budesonide/glycopyrrolate/formoterol fumarate triple therapy delivered using next generation propellants with low global warming potential. Pulm Pharmacol Ther. 2023 Dec;83:102245. doi: 10.1016/j.pupt.2023.102245. Epub 2023 Aug 20.
CSR SynopsisLink provided by the sponsor.
CSP \& SAPLink 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 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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Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive

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.

David Han, Dr. principal investigator

PAREXEL Early Phase Clinical Unit-Los Angeles

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, Treatment B and Treatment C in people with Chronic Obstructive Pulmonary Disease (COPD), 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 5 inclusion and 35 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 23 Jan 2023. 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 23 Jan 2023). 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 Concentration (Cmax) of BGF MDI (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 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 NCT04600505, 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 23 Jan 2023.