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

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

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

Conditions1

Browse More Trials