New inhaler BGF 160 studied for COPD breathing issues
NCT ID NCT06110403
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing an inhaler called BGF 160 (also known as Breztri Aerosphere) in 35 adults with stable COPD. The goal is to see how the medicine changes the complexity and variability of breathing patterns over 30 days. Participants will use the inhaler twice daily, and researchers will measure lung function and breathing mechanics. This is an early-phase, open-label study to understand how the drug works, not to prove it cures COPD.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BGF 160 (budesonide, glycopyrrolate, formoterol fumarate) as an inhaler
- What this could lead to
- If successful, this could show how BGF 160 improves breathing patterns in COPD, supporting its use for symptom control.
- What could go wrong
- This is a small, early-phase study (35 people) with no placebo group, so results may not be conclusive or apply to all COPD patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 75 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: * Provision of signed informed consent prior to any study specific procedure * Female or male subjects aged 40-75 years inclusive at the time of enrolment (Visit 1) * Documented history of COPD with a post-bronchodilator FEV1/FVC \<0.70 and a post-bronchodilator 30 % \< FEV1 \<70% of predicted normal value (according to ERS 1993 reference values for spirometry ) at screening * Smoking history \> 10 pack-years * Baseline significant dyspnea with a mMRC ≥ 2 Exclusion Criteria: * History or current diagnosis of asthma or ACOS (asthma-COPD overlap syndrome) * Respiratory infection or COPD exacerbation within 6 weeks (2 months if it resulted in hospitalization) prior to screening * Clinically significant or relevant cardiovascular conditions, laboratory tests, electrocardiogram (ECG) parameters: * Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months. * Congestive heart failure New York Heart Association (NYHA) class III/IV. * Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease). * Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia. * Left bundle branch or high-degree AV block (second degree AV block type 2 and third degree AV block) unless the patient has a pacemaker. * Sinus node dysfunction with pauses. * Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome. * QTcF interval \>470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/\[RR1/3\]). * Any other ECG abnormality deemed clinically significant by the Investigator. * Bradycardia with ventricular rate \< 45 bpm. * Uncontrolled hypertension (\> 165/95 mmHg). * Clinically relevant respiratory conditions (other than COPD) * Severe renal impairment eGFR \< 30 * Hepatic impairment * Narrow-angle glaucoma that, in the opinion of the Investigator, has not been adequately treated. * Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that is clinically significant * Patients not able to perform IOS, spirometry, plethysmography, or VT acquisition (10 min) * Any contraindication to LABA or LAMA drugs or to Inhaled corticosteroids * Pregnancy or breastfeeding * Woman of childbearing age without effective contraception * Any type of cancer within 5 years * Patients under guardianship * Refuse or incapacity to give an informed consent * Absence of social insurance
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU de Lille
RECRUITINGLille, France
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