2024-514097-52-00RecruitingPhase 4
Impact of Inhaled BGF 160 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient
Centre Hospitalier Universitaire De Lille1 site in 1 country35 target enrollmentStarted: September 29, 2023Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
To evaluate the change in ventilation pattern complexity and variability after 1 month of treatment by BGF 160
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Primary Purpose
- Multicentre, prospective, non-randomised, single-arm, open label,
- Masking
- None
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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 Outcomes
- 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)
- 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
Investigators
Thierry PEREZ
Scientific
Centre Hospitalier Universitaire De Lille
Study Sites (1)
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