Impact of inhaled BGF 160 on complexity and variability of tidal breathing and oscillatory mechanics in stable COPD patient MedDRA version: 21.0 Level: LLT Classification code 10070975 Term: Chronic obstructive bronchopneumopathy System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Trixeo Aérosphère
Product Name: Trixéo Aerosphere
Product Code: BGF 160
Pharmaceutical Form: Suspension and solution for spray
Sponsors
CHU DE LILLE
Eligibility
Sex/Gender
All
Inclusion 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 10 pack-years - Baseline significant dyspnea with a mMRC = 2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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: o Unstable angina/acute coronary syndrome, or Coronary Artery Bypass Grafting (CABG), Percutaneous Coronary Intervention (PCI) or myocardial infarction within the past 6 months. o Congestive heart failure New York Heart Association (NYHA) class III/IV. o Structural heart disease (hypertrophic cardiomyopathy, significant valvular disease). o Paroxysmal (within the past 6 months) or symptomatic chronic cardiac tachyarrhythmia. o 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. o Sinus node dysfunction with pauses. o Ventricular pre-excitation and/or Wolff-Parkinson-White syndrome. o QTcF interval >470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/[RR1/3]). o Any other ECG abnormality deemed clinically significant by the Investigator. o Bradycardia with ventricular rate 165/95 mmHg). - Clinically relevant respiratory conditions (other than COPD) - Severe renal impairment eGFR 470 msec (QT interval corrected using Fridericia's formula; QTcF=QT/[RR1/3]). o Any other ECG abnormality deemed clinically significant by the Investigator. o Bradycardia with ventricular rate 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 - Freedom privacy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the change in ventilation pattern complexity and variability after 1 month of treatment by BGF 160;Secondary Objective: 1.To assess the change in Oscillatory mechanics, Flows and Lung volumes one month after administration of BGF 160 2. To assess the association between clinical response on dyspnea (TDI at V3) and the changes of variability/PFT between V2 and V3 3. To compare dyspnea and symptoms before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30min) at one month) 4.To compare the ventilation pattern variability and complexity at the other time points : -V2 baseline vs V2 peak (first dose effect) -V2 baseline vsV3 trough (residual effect) ;Primary end point(s): Analysis of tidal volume (VT) complexity (noise limit as main parameter ) : Comparison of the noise limit between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30min) post dose ) ;Timepoint(s) of evaluation of this end point: During patients visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Outcome Measure 1:Change between V2 base (pre-treatment) and V3 peak (2 hours (+/-30min) post dose) of : - Impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz - Spirometry: Changes in FEV1 - Plethysmographic Functional residual capacity (FRC) Outcome Measure 2:Changes between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min) measurement for noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1and FRC versus TDI at V3 (in term of continuous variable and in term of binary variable “responder/non responder”; a response is defined by a change in TDI =+1 between baseline and V3) Outcome Measure 3: - dyspnea scores: - Baseline dyspnea index ( BDI) - Transition dyspnea index (TDI) - Modified dyspnea profile ( MDP) - CAT score - Likert scale for dyspnea and general health Outcome Measure 4:Noise limit, respiratory frequency, volume, largest Lyapounov compone, resistances at 5Hz, reactance at 5Hz, FEV1, FRC ,and VAS dyspnea/chest tightness ;Timepoint(s) of evaluation of this end point: During patients visits | — |
Countries
France
Contacts
Public ContactRabah TEZKRATT (CRA)
CHU de Lille (clinical research direction)
Outcome results
None listed