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COMPLETEDPHASE3

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)

NCT06067828•AstraZeneca

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
+1 more criteria

Exclusion Criteria

•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.
+6 more criteria

Locations (33)

Research Site

Los Angeles, California, United States

Research Site

Tarzana, California, United States

Research Site

Torrance, California, United States

Research Site

Brooksville, Florida, United States

Research Site

Anderson, South Carolina, United States

Research Site

Greenville, South Carolina, United States

Research Site

Spartanburg, South Carolina, United States

Research Site

Edmonton, Alberta, Canada

Research Site

Kingston, Ontario, Canada

Research Site

Sainte-Foy, Quebec, Canada

Key Dates

Start Date

October 24, 2023

Primary Completion Date

January 22, 2026

Completion Date

January 22, 2026

Last Updated

March 5, 2026

Enrollment

171

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Treatment A : Budesonide, Glycopyrronium, and Formoterol Fumarate

DRUG

Treatment B: Budesonide and Formoterol Fumarate

DRUG

Treatment C : Placebo

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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).

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

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