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

University Hospital, Lille

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Copd

Treatments: Drug: TRIXEO AEROSPHERE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06110403

2022_0422

2022-003784-15 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 35 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Experimental group

Experimental group

Description:

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

Treatment:

Drug: TRIXEO AEROSPHERE