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New inhaler BGF 160 studied for COPD breathing issues

NCT ID NCT06110403

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

40 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CHU de Lille

    RECRUITING

    Lille, France

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