Chronic Obstructive Pulmonary DiseasePhase 4ORATOSNCT07073950
A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation
A Phase 4 study testing Budesonide/Glycopyrronium/Formoterol Fumarate and Metered dose inhaler in people with Chronic Obstructive Pulmonary Disease and Hyperinflation, run by AstraZeneca at 7 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hyperinflation
- What is being tested?
- Budesonide/Glycopyrronium/Formoterol Fumarate and Metered dose inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 24 Nov 2025to 31 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
- A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7.
- At Visit 1: A pre-bronchodilator FEV1 < 80%.
- At Visit 1: Peripheral blood eosinophil count < 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count > 300 cells/mm³ in the past 12 months.
- At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
- At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of > 135% of predicted normal FRC.
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- At Visit 2: A post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value.
- Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
- Female participants must either be not of childbearing potential or using a form of highly effective birth control.
- All women of child bearing potential must have a negative pregnancy test at the Visit 1.
Who cannot join
- A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
- History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
- History of myocardial infarction or acute coronary syndrome.
- History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
- Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
- Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.
- Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
- Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
7 sites in 2 countries
Germany4 sites, 4 recruiting
- Recruiting
Research Site
Ahrensburg, 22926
- Recruiting
Research Site
Berlin, 14050
- Recruiting
Research Site
Frankfurt, 60596
- Recruiting
Research Site
Hanover, 30625
United Kingdom3 sites, 2 recruiting
- Withdrawn
Research Site
Harefield, UB9 6JH
- Recruiting
Research Site
London, W1T 6AH
- Recruiting
Research Site
Manchester, M23 9QZ
About this study
Official title: A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Read the detailed description
This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and lung function will be evaluated in patients with COPD and hyperinflation.
The study will comprise of:
- Screening period
- Participants will receive placebo inhaler and salbutamol before randomization
- Two treatment periods of 21 days each, where participants will be randomized 1:1 to receive either the study intervention BGF metered-dose inhaler (MDI) or placebo in Period 1 then crossover to matching placebo or BGF in Period 2
- A final follow-up period
- Being tested
- Budesonide/Glycopyrronium/Formoterol Fumarate, Placebo, Metered dose inhaler
- Keywords
- Metered Dose Inhalers (MDI), Inhaled Corticosteroid (ICS), Long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA)
- 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.
Budesonide/Glycopyrronium/Formoterol FumarateDrug
BGF will be administered as 2 inhalations via oral route of administration
PlaceboDrug
Matching placebo will be administered as 2 inhalations via oral route of administration
Metered dose inhalerDevice
Participants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: BGF MDI and Placebo | Experimental | Participants will receive BGF MDI in Period 1 followed by Placebo in Period 2. Receives: Drug: Budesonide/Glycopyrronium/Formoterol Fumarate; Drug: Placebo; Device: Metered dose inhaler |
| Sequence 2: Placebo and BGF MDI | Experimental | Participants will receive Placebo in Period 1 followed by BGF MDI in Period 2. Receives: Drug: Budesonide/Glycopyrronium/Formoterol Fumarate; Drug: Placebo; Device: Metered dose inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)
The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.
Measured: Up to 3 weeks
Secondary outcomes (2)
Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography
The effect of BGF relative to placebo on FRC/TLC will be evaluated.
Measured: Up to 3 weeks
Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography
The effect of BGF relative to placebo on RV/TLC will be evaluated.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start24 Nov 2025
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07073950
- Sponsor's protocol ID
- D5980C00048
- Other IDs
- 2025-521987-37-00, 2025
- Acronym
- ORATOS
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2025
- Last updated
- 18 Sep 2026
- 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. 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants With Chronic Obstructive Pulmonary Disease and Hyperinflation
- ClinicalTrials.gov ID
- NCT07073950
- Acronym / sponsor ID
- ORATOS / D5980C00048
- Keywords
- Metered Dose Inhalers (MDI), Inhaled Corticosteroid (ICS), Long-acting muscarinic antagonist (LAMA), Long-acting beta2 agonist (LABA)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 Jul 2025 (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 purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Detailed description
This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and lung function will be evaluated in patients with COPD and hyperinflation.
The study will comprise of:
- Screening period
- Participants will receive placebo inhaler and salbutamol before randomization
- Two treatment periods of 21 days each, where participants will be randomized 1:1 to receive either the study intervention BGF metered-dose inhaler (MDI) or placebo in Period 1 then crossover to matching placebo or BGF in Period 2
- A final follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: BGF MDI and Placebo | Experimental | Drug: Budesonide/Glycopyrronium/Formoterol Fumarate, Drug: Placebo, Device: Metered dose inhalerParticipants will receive BGF MDI in Period 1 followed by Placebo in Period 2. |
| Sequence 2: Placebo and BGF MDI | Experimental | Drug: Budesonide/Glycopyrronium/Formoterol Fumarate, Drug: Placebo, Device: Metered dose inhalerParticipants will receive Placebo in Period 1 followed by BGF MDI in Period 2. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
- A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7.
- At Visit 1: A pre-bronchodilator FEV1 < 80%.
- At Visit 1: Peripheral blood eosinophil count < 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count > 300 cells/mm³ in the past 12 months.
- At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.
Key exclusion criteria (8 listed)
- A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
- History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
- History of myocardial infarction or acute coronary syndrome.
- History or current clinically significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
- Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
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 |
|---|---|---|
| Budesonide/Glycopyrronium/Formoterol FumarateBGF will be administered as 2 inhalations via oral route of administration | Drug | Sequence 1: BGF MDI and Placebo, Sequence 2: Placebo and BGF MDI |
| PlaceboMatching placebo will be administered as 2 inhalations via oral route of administration | Drug | Sequence 1: BGF MDI and Placebo, Sequence 2: Placebo and BGF MDI |
| Metered dose inhalerParticipants will receive BGF and matching placebo via metered dose inhaler in treatment periods of the study. | Device | Sequence 1: BGF MDI and Placebo, Sequence 2: Placebo and BGF MDI |
Primary outcome
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI)
Time frame: Up to 3 weeks
The effect of BGF relative to placebo on LVEDVi in participants with COPD and hyperinflation will be evaluated.
2 secondary outcomes
Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography
Time frame: Up to 3 weeks
Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography
Time frame: Up to 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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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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.
AstraZeneca Clinical Study Information Center contact
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide/Glycopyrronium/Formoterol Fumarate and Metered dose inhaler in people with Chronic Obstructive Pulmonary Disease and Hyperinflation, run by AstraZeneca at 7 sites in 2 countries.
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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United Kingdom. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in left ventricular end diastolic volume indexed by body surface area (LVEDVi) measured by magnetic resonance imaging (MRI) (time frame: Up to 3 weeks). 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 18 Sep 2026.