Status:
RECRUITING
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
AstraZeneca
Conditions:
Copd
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
PHASE2
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06110403
Start Date
September 29 2023
End Date
September 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
CHU de Lille
Lille, France