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).
ATHLOS
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)
1 other identifier
interventional
171
7 countries
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease
Started Oct 2023
Typical duration for phase_3 chronic-obstructive-pulmonary-disease
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedStudy Start
First participant enrolled
October 24, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 22, 2026
CompletedMarch 5, 2026
February 1, 2026
2.2 years
September 28, 2023
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 weeks post-treatment
Secondary Outcomes (9)
Change from baseline in constant work rate cycle ergometry endurance time
2 weeks post-treatment
Change from baseline in Isotime dyspnea (NRS)
2 weeks post-treatment
Change from baseline in functional residual capacity (FRC)
2 weeks post-treatment
Change from baseline in total lung capacity (TLC)
2 weeks post-treatment
Change from baseline in residual volume (RV)
2 weeks post-treatment
- +4 more secondary outcomes
Study Arms (3)
BGF MDI
ACTIVE COMPARATORPressurized MDI fixed combination product of Budesonide 160 μg, Glycopyrronium 7.2 μg, and Formoterol Fumarate 4.8 μg per actuation.
BFF MDI
ACTIVE COMPARATORPressurized MDI fixed combination product of Budesonide 160 μg and Formoterol Fumarate 4.8 μg per actuation.
Placebo
PLACEBO COMPARATORPlacebo as pressurized inhalation suspension.
Interventions
Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).
Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.
Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (33)
Research Site
Los Angeles, California, 90095, United States
Research Site
Tarzana, California, 91356, United States
Research Site
Torrance, California, 90502, United States
Research Site
Brooksville, Florida, 34613, United States
Research Site
Anderson, South Carolina, 29621, United States
Research Site
Greenville, South Carolina, 29615, United States
Research Site
Spartanburg, South Carolina, 29303, United States
Research Site
Edmonton, Alberta, T6G 2B7, Canada
Research Site
Kingston, Ontario, K7L 2V7, Canada
Research Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Research Site
Guangzhou, 510163, China
Research Site
Nanchang, 330006, China
Research Site
Shenyang, 110001, China
Research Site
Zhengzhou, 450000, China
Research Site
Berlin, 12159, Germany
Research Site
Berlin, 14050, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Großhansdorf, 22927, Germany
Research Site
Hanover, 30449, Germany
Research Site
Heidelberg, 69115, Germany
Research Site
Lübeck, 23552, Germany
Research Site
Mainz, 55128, Germany
Research Site
Daegu, 42415, South Korea
Research Site
Seoul, 02447, South Korea
Research Site
Seoul, 05030, South Korea
Research Site
Benalmádena, 29630, Spain
Research Site
Madrid, 28007, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Seville, 41013, Spain
Research Site
Leicester, LE1 5WW, United Kingdom
Research Site
London, SW3 6HP, United Kingdom
Research Site
London, W1T 6AH, United Kingdom
Research Site
Manchester, M23 9GP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2023
First Posted
October 5, 2023
Study Start
October 24, 2023
Primary Completion
January 22, 2026
Study Completion
January 22, 2026
Last Updated
March 5, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.