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

NCT06110403 | Recruiting Phase 1

• 2 other identifiers: 2022_04222022-003784-15
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Copd

Keywords

COPD; bronchodilator; ventilatory mode; variability; forced oscillations; spirometry; plethysmography; dyspnea

Outcome Measures

Primary Outcomes (1)

• change in ventilation pattern complexity and variability

  * Noise limit: % * Lyapounov component: bits/iteration no combination possible

  between V2 baseline (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose at one month)

Secondary Outcomes (9)

• Change impulse oscillometry or forced oscillation: resistances at 5Hz, reactance at 5Hz

  between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose

• Changes in FEV1 (spirometry)

  between V2 base (pre-treatment) and V3 peak (2 hours (+/-30minutes) post dose

• Change Plethysmographic Functional residual capacity (FRC)

  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

  between V2 base measurement (pre-treatment) and V3 peak (2 hours (+/-30min)

• Baseline dyspnea index ( BDI)

  before administration of BGF 160 (at V2 base (pre-treatment)) and after administration (at V3 peak (2 hours (+/-30minutes) at one month)

Study Arms (1)

Experimental group

EXPERIMENTAL

Symptomatic COPD patients in stable condition treated with BGF 160 (Trixéo Aerosphere®), a combination of budesonide, formoterol and glycopyrronium in a metered dose inhaler, taken twice a day

Drug: TRIXEO AEROSPHERE

Interventions

TRIXEO AEROSPHERE DRUG

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.

Experimental group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead
• AstraZeneca: collaborator

Study Sites (1)

CHU de Lille

Lille, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Thierry PEREZ, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thierry PEREZ, MD

CONTACT

0320445962; thierry.perez@chu-lille.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: October 31, 2023
• Study Start: September 29, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Locations

FR (1)