Effects of a new inhaler on lung function and breathlessness in COPD patients

Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient

This study is testing a new inhaler called TRIXEO AEROSPHERE to see if it can improve breathing and lung function in adults with COPD who often feel short of breath.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: University Hospital, Lille (other)
• Locations: 1 site (Lille)
• Trial ID: NCT06110403 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, non-randomized, single-arm study aims to investigate the effects of the inhaled therapy TRIXEO AEROSPHERE on ventilation patterns and lung function in patients with chronic obstructive pulmonary disease (COPD). Participants will be adults aged 40-75 with a documented history of COPD and significant dyspnea. The study will assess the mechanism of action of the treatment and its impact on breathlessness and lung function variability. The study will not involve randomization, allowing for a focused examination of the treatment's effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-75 with a documented history of COPD and significant dyspnea.

Not a fit: Patients with asthma or those experiencing recent respiratory infections or significant cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of COPD symptoms and enhanced quality of life for patients.

How similar studies have performed: Other studies have shown promising results with similar inhaled therapies for COPD, indicating potential for success.

Eligibility criteria

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

Where this trial is running

Lille

• CHU de Lille — Lille, France (RECRUITING)

Study contacts

• Principal investigator: Thierry PEREZ, MD — University Hospital, Lille
• Study coordinator: Thierry PEREZ, MD

Conditions: Copd, COPD, bronchodilator, ventilatory mode, variability, forced oscillations, spirometry, plethysmography