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

2022_0422

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

2023-09-29

2025-09-01

2025-09-01

Recruiting

Early phase I

35

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}

2023-10-31