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New treatment option for Copd
Official title Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
ClinicalTrials.gov ID: NCT06110403
What this study is testing
What is TRIXEO AEROSPHERE?
TRIXEO AEROSPHERE is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for copd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Multicentre, prospective, non-randomised, single-arm, open label, mechanistic study to investigate the mechanism of action of BGF 160 on ventilation pattern complexity and variability
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- Provision of signed informed consent prior to any study specific procedure
- Female or male people 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...
- Smoking history \> 10 pack-years
- Baseline significant dyspnea with a mMRC ≥ 2
You likely can't join if
- 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...
- Congestive heart failure New York Heart Association (NYHA) class III/IV.
- Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease).
See the full eligibility criteria
- Provision of signed informed consent prior to any study specific procedure
- Female or male people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.