Chronic Obstructive Pulmonary DiseasePhase 3ATHLOSNCT06067828
A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).
A Phase 3 study testing Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate and Treatment B: Budesonide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 33 sites in 7 countries.
Trial summary
This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate and Treatment B: Budesonide and Formoterol Fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 171 participants
- Where
- 33 sitesin 7 countries
- Study dates
- 24 Oct 2023to 22 Jan 2026
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.
- Participant must have:
- a diagnosis of COPD confirmed by a post-bronchodilator Forced expiratory volume (FEV1)/ Forced vital capacity (FVC) < 0.7 at Visit 1
- a post-bronchodilator FEV1 ≥ 30% and <80% predicted normal (moderate to severe COPD) at Visit 1.
- a score of ≥ 2 on the modified Medical Research Council at Visit 1.
- pre-bronchodilator FRC of > 120% of predicted normal FRC values at Visit 1.
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- a constant work rate test endurance time of 3 to 8 minutes at Visit 2.
- Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.
- Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking
- Body mass index < 40 kg/m2.
- Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception.
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.
- Historical or current evidence of a clinically significant disease
- Participants on oxygen therapy or that desaturate significantly (<82%) during exercise.
- Participants who are enrolled or entering a pulmonary rehabilitation program during the study.
- Participants who have cancer that has not been in complete remission for at least 5 years.
- Participants with a diagnosis of narrow-angle glaucoma that has not been adequately treated and/or change in vision that may be relevant, in the opinion of the investigator.
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- Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
- Participants who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI or dry powder inhaler.
- Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%.
- A COPD exacerbation that requires hospitalization within 12 months prior to Visit 1 or a COPD exacerbation that requires systemic corticosteroids or antibiotics within 4 months of Visit 1.
- Participants with contraindications to cardiopulmonary exercise testing (CPET).
- Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening period.
- Participants with lung lobectomy, lung volume reduction or lung transplantation.
- Unable to withhold short-acting bronchodilators for 6 hours prior to lung function testing at each study visit.
- Known history of drug or alcohol abuse within 12 months.
- Any regular recreational use of marijuana in the 12 months.
Trial locations and contacts
33 sites in 7 countries.
33 sites in 7 countries
Germany8 sites
Research Site
Berlin, 12159
Research Site
Berlin, 14050
Research Site
Frankfurt, 60596
Research Site
Großhansdorf, 22927
Research Site
Hanover, 30449
Research Site
Heidelberg, 69115
Research Site
Lübeck, 23552
Research Site
Mainz, 55128
United States7 sites
Research Site
Anderson, South Carolina, 29621
Research Site
Brooksville, Florida, 34613
Research Site
Greenville, South Carolina, 29615
Research Site
Los Angeles, California, 90095
Research Site
Spartanburg, South Carolina, 29303
Research Site
Tarzana, California, 91356
Research Site
Torrance, California, 90502
China4 sites
Research Site
Guangzhou, 510163
Research Site
Nanchang, 330006
Research Site
Shenyang, 110001
Research Site
Zhengzhou, 450000
Spain4 sites
Research Site
Benalmádena, 29630
Research Site
Madrid, 28007
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41013
United Kingdom4 sites
Research Site
Leicester, LE1 5WW
Research Site
London, SW3 6HP
Research Site
London, W1T 6AH
Research Site
Manchester, M23 9GP
Canada3 sites
Research Site
Edmonton, Alberta, T6G 2B7
Research Site
Kingston, Ontario, K7L 2V7
Research Site
Sainte-Foy, Quebec, G1V 4G5
South Korea3 sites
Research Site
Daegu, 42415
Research Site
Seoul, 02447
Research Site
Seoul, 05030
About this study
Official title: A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants With COPD (ATHLOS)
This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.
Read the detailed description
This is a multicenter, three-treatment, three-period, cross-over study to assess the effect of BGF MDI vs Placebo MDI and BFF MDI in participants with COPD who have exertional breathlessness despite treatment with mono or dual COPD maintenance therapy.
Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate, Treatment B: Budesonide and Formoterol Fumarate, Treatment C : Placebo
- Keywords
- Metered Dose Inhalers
- 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 : Budesonide, Glycopyrronium, and Formoterol FumarateDrug
Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).
Treatment B: Budesonide and Formoterol FumarateDrug
Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.
Treatment C : PlaceboDrug
Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.
| Study group | Role | What they receive |
|---|---|---|
| BGF MDI | Active comparator | Pressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation. Receives: Drug: Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate |
| BFF MDI | Active comparator | Pressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation. Receives: Drug: Treatment B: Budesonide and Formoterol Fumarate |
| Placebo | Placebo comparator | Placebo as pressurized inhalation suspension. Receives: Drug: Treatment C : Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in isotime Inspiratory capacity (IC)
To assess the effect of BGF MDI relative to Placebo MDI and BGF MDI relative to BFF MDI on dynamic hyperinflation in participants with COPD.
Measured: 2 weeks post-treatment
Secondary outcomes (9)
Change from baseline in constant work rate cycle ergometry endurance time
To assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on exercise endurance time in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in Isotime dyspnea (NRS)
To assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on Isotime dyspnea in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in functional residual capacity (FRC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on FRC in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in total lung capacity (TLC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on TLC in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in residual volume (RV)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in RV/TLC
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV/TLC in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in specific airway conductance (sGaw)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on sGaw in participants with COPD.
Measured: 2 weeks post-treatment
Change from baseline in static Inspiratory capacity (IC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on static IC in participants with COPD.
Measured: 2 weeks post-treatment
Number of participants with serious adverse events (SAEs) and adverse event leading to discontinuation of study intervention (DAEs).
To assess the safety and tolerability of BGF MDI and BFF MDI.
Measured: 2 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start24 Oct 2023
- Primary completion22 Jan 2026
- Study completion22 Jan 2026
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067828
- Sponsor's protocol ID
- D5988C00001
- Acronym
- ATHLOS
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2023
- Last updated
- 5 Mar 2026
- 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 approved.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multicentre, Randomized, Three-Period, Three-Treatment, Cross-Over Study to Evaluate the Effect of BGF MDI, BFF MDI, and Placebo MDI on Exercise Parameters in Participants With COPD (ATHLOS)
- ClinicalTrials.gov ID
- NCT06067828
- Acronym / sponsor ID
- ATHLOS / D5988C00001
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Metered Dose Inhalers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 22 Jan 2026 (actual)
- Study completion
- 22 Jan 2026 (actual)
- First posted
- 5 Oct 2023 (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 will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.
Detailed description
This is a multicenter, three-treatment, three-period, cross-over study to assess the effect of BGF MDI vs Placebo MDI and BFF MDI in participants with COPD who have exertional breathlessness despite treatment with mono or dual COPD maintenance therapy.
Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BGF MDI | Active comparator | Drug: Treatment A : Budesonide, Glycopyrronium, and Formoterol FumaratePressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation. |
| BFF MDI | Active comparator | Drug: Treatment B: Budesonide and Formoterol FumaratePressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation. |
| Placebo | Placebo comparator | Drug: Treatment C : PlaceboPlacebo as pressurized inhalation suspension. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participant must be male or female, 40 to 80 years of age inclusive, at the time of signing the informed consent.
- Participant must have:
- Participant must be on a stable dose of mono-or dual inhaled maintenance COPD treatment for at least 6 weeks.
- Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking
- Body mass index < 40 kg/m2.
Key exclusion criteria (16 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.
- Historical or current evidence of a clinically significant disease
- Participants on oxygen therapy or that desaturate significantly (<82%) during exercise.
- Participants who are enrolled or entering a pulmonary rehabilitation program during the study.
- Participants who have cancer that has not been in complete remission for at least 5 years.
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 : Budesonide, Glycopyrronium, and Formoterol FumarateRandomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID). | Drug | BGF MDI |
| Treatment B: Budesonide and Formoterol FumarateRandomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID. | Drug | BFF MDI |
| Treatment C : PlaceboRandomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID. | Drug | Placebo |
Primary outcome
Change from baseline in isotime Inspiratory capacity (IC)
Time frame: 2 weeks post-treatment
To assess the effect of BGF MDI relative to Placebo MDI and BGF MDI relative to BFF MDI on dynamic hyperinflation in participants with COPD.
9 secondary outcomes
Change from baseline in constant work rate cycle ergometry endurance time
Time frame: 2 weeks post-treatment
Change from baseline in Isotime dyspnea (NRS)
Time frame: 2 weeks post-treatment
Change from baseline in functional residual capacity (FRC)
Time frame: 2 weeks post-treatment
Change from baseline in total lung capacity (TLC)
Time frame: 2 weeks post-treatment
Change from baseline in residual volume (RV)
Time frame: 2 weeks post-treatment
Change from baseline in RV/TLC
Time frame: 2 weeks post-treatment
Change from baseline in specific airway conductance (sGaw)
Time frame: 2 weeks post-treatment
Change from baseline in static Inspiratory capacity (IC)
Time frame: 2 weeks post-treatment
Number of participants with serious adverse events (SAEs) and adverse event leading to discontinuation of study intervention (DAEs).
Time frame: 2 weeks post-treatment
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 Mar 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 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.
33 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate and Treatment B: Budesonide and Formoterol Fumarate in people with Chronic Obstructive Pulmonary Disease, run by AstraZeneca at 33 sites in 7 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 11 inclusion and 16 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 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, United States, China, Spain, United Kingdom and 2 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in isotime Inspiratory capacity (IC) (time frame: 2 weeks post-treatment). 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 Mar 2026.