New inhaler helps COPD patients breathe easier during exercise
NCT ID NCT06067828
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a triple-combination inhaler (BGF) in 171 adults with moderate-to-severe COPD. Participants received BGF, a dual-combination inhaler (BFF), or placebo in random order. The goal was to see if BGF improves breathing capacity and exercise endurance compared to the other treatments. Results may help guide better symptom management for COPD.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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171 people
The number who actually took part.
- Started
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Oct 2023
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * Male and Female participants (not applicable for female participants with non-childbearing potential) and their partners must use an acceptable method of contraception. 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Los Angeles, California, 90095, United States
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Research Site
Tarzana, California, 91356, United States
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Research Site
Torrance, California, 90502, United States
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Research Site
Brooksville, Florida, 34613, United States
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Research Site
Anderson, South Carolina, 29621, United States
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Research Site
Greenville, South Carolina, 29615, United States
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Research Site
Spartanburg, South Carolina, 29303, United States
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Research Site
Edmonton, Alberta, T6G 2B7, Canada
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Research Site
Kingston, Ontario, K7L 2V7, Canada
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Research Site
Sainte-Foy, Quebec, G1V 4G5, Canada
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Research Site
Guangzhou, 510163, China
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Research Site
Nanchang, 330006, China
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Research Site
Shenyang, 110001, China
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Research Site
Zhengzhou, 450000, China
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Research Site
Berlin, 12159, Germany
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Research Site
Berlin, 14050, Germany
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Research Site
Frankfurt, 60596, Germany
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Research Site
Großhansdorf, 22927, Germany
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Research Site
Hanover, 30449, Germany
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Research Site
Heidelberg, 69115, Germany
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Research Site
Lübeck, 23552, Germany
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Research Site
Mainz, 55128, Germany
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Research Site
Daegu, 42415, South Korea
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Research Site
Seoul, 02447, South Korea
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Research Site
Seoul, 05030, South Korea
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Research Site
Benalmádena, 29630, Spain
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Research Site
Madrid, 28007, Spain
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Research Site
Santiago de Compostela, 15706, Spain
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Research Site
Seville, 41013, Spain
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Research Site
Leicester, LE1 5WW, United Kingdom
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Research Site
London, SW3 6HP, United Kingdom
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Research Site
London, W1T 6AH, United Kingdom
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Research Site
Manchester, M23 9GP, United Kingdom
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