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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
CHU de Lille
Lille, France
RECRUITINGchange in ventilation pattern complexity and variability
* Noise limit: % * Lyapounov component: bits/iteration no combination possible
Time frame: between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)
Change impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz
resistance and reactance: kPa/L/s
Time frame: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Changes in FEV1 (spirometry)
Time frame: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Change Plethysmographic Functional residual capacity (FRC)
Time frame: between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose
Changes measurement for noise limit, respiratory frequency, volume, largest Lyapounov component, resistances at 5Hz, reactance at 5Hz, FEV1and FRC versus TDI at V3
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)
Time frame: between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min)
Baseline dyspnea index ( BDI)
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
Transition dyspnea index (TDI)
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
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Modified dyspnea profile ( MDP)
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)
CAT score : COPD assessment test,
range 0 to 40, 40 meaning the worst condition
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes at one month)
Likert scale for dyspnea and general health
Likert scale change in dyspnea : - 3 to + 3, + 3 maximal improvement, -3 maximal deterioration Likert scale change in general health : - 3 to + 3, + 3 maximal improvement, -3 maximal deterioration
Time frame: before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)