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

Phase 4

Not yet recruiting

Conditions: Impact of inhaled BGF 160 on complexity and variability of tidal breathing and oscillatory mechanics in stable COPD patient

Registration Number: 2024-514097-52-00

Lead Sponsor: Centre Hospitalier Universitaire De Lille

Brief Summary: To evaluate the change in ventilation pattern complexity and variability after 1 month of treatment by BGF 160

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised, recruitment pending

Sex: Not specified

Target Recruitment: 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)

Any contraindication or allergy to LABA or LAMA drugs or to Inhaled corticosteroids

Treatment by an azole systemic antifungal (itraconazole, fluconazole…)

Treatment by a protease inhibitor or cobicistat for HIV

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

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 < 45 bpm. o 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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple primary endpoints characterizing the change in ventilation pattern complexity and variability between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30min) post dose at one month) : noise limit, respiratory frequency, volume and largest Lyapounov component (an indicator of the sensitivity of the system to initial condition.		Multiple primary endpoints characterizing the change in ventilation pattern complexity and variability between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30min) post dose at one month) : noise limit, respiratory frequency, volume and largest Lyapounov component (an indicator of the sensitivity of the system to initial condition.

Secondary Outcome Measures

Name	Time	Method
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)		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)
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)		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)
Dyspnea and symptom scores: - Baseline dyspnea index ( BDI) - Transition dyspnea index (TDI) - Modified dyspnea profile ( MDP) - CAT score - Likert scale for dyspnea and general health		Dyspnea and symptom scores: - Baseline dyspnea index ( BDI) - Transition dyspnea index (TDI) - Modified dyspnea profile ( MDP) - CAT score - Likert scale for dyspnea and general health
Noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1, FRC, and VAS dyspnea/chest tightness		Noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1, FRC, and VAS dyspnea/chest tightness

Trial Locations

Locations (3): Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷
Grenoble Cedex 9, France
Assistance Publique Hopitaux De Paris
🇫🇷
Paris, France
Centre Hospitalier Universitaire De Lille
🇫🇷
Lille, France
Centre Hospitalier Universitaire Grenoble Alpes
🇫🇷Grenoble Cedex 9, France
DEGANO Bruno
Site contact
+33476766970
bdegano@chu-grenoble.fr