Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function an… (NCT06110403) | Clinical Trial Compass
RecruitingPhase 1/2
Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
France35 participantsStarted 2023-09-29
Plain-language 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
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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-Wh…
What they're measuring
1
change in ventilation pattern complexity and variability
Timeframe: between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)