RecruitingPhase 1Phase 2NCT06110403

Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness

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

Sponsor

University Hospital, Lille

Enrollment

35 participants

Start Date

Sep 29, 2023

Study Type

INTERVENTIONAL

Conditions

COPD

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria27

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

Interventions

DRUGTRIXEO AEROSPHERE

BGF 160 (Breztri Aerosphere™ in USA, Trixeo™ in France) Inhalation aerosol: pressurized metered dose inhaler containing a combination of budesonide (160 mcg), glycopyrrolate (9 mcg) and formoterol fumarate (4.8 mcg) as an inhalation aerosol. Oral inhalation: 2 inhalations of BGF 160 twice daily for 30 days.