NCT06067828CompletedPhase 3
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 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)
Source: ClinicalTrials.gov · Last updated 5 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 171 (actual)
- First submitted
- 28 Sept 2023
- Start date
- 24 Oct 2023
- Primary completion date
- 22 Jan 2026
- Lead sponsor
- AstraZeneca
- Diseases
- COPD
- NCT number
- NCT06067828
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 171
- From 24 Oct 2023 to the primary completion date, 22 Jan 2026
- 30 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants on oxygen therapy or that desaturate significantly (\<82%) during exercise.
- 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 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.
Other illness
- 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 who have cancer that has not been in complete remission for at least 5 years.
- 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.
- Known history of drug or alcohol abuse within 12 months.
Other
- Participants who are enrolled or entering a pulmonary rehabilitation program during the study.
- 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.
- Participants with symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the investigator, is clinically significant.
- Participant with resting (5 minutes) oxygen saturation SaO2 in room air ≤ 85%.
- Participants with contraindications to cardiopulmonary exercise testing (CPET).
- Any regular recreational use of marijuana in the 12 months.
Who the study is looking for
- 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.
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Research Site Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Sainte-Foy | Canada | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Großhansdorf | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Benalmádena | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Anderson | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Brooksville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Tarzana | United States | Unknown status |
| Research Site Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.