Impact of Long-acting Bronchodilator- -Corticoid Inhaled Therapy on Ventilation, Lung Function and Breathlessness
NCT ID: NCT06110403
Last Updated: 2023-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
35 participants
INTERVENTIONAL
2023-09-29
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental group
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
TRIXEO AEROSPHERE
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.
Interventions
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TRIXEO AEROSPHERE
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
University Hospital, Lille
OTHER
Responsible Party
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Principal Investigators
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Thierry PEREZ, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Lille
Locations
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CHU de Lille
Lille, , France
Countries
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Central Contacts
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Facility Contacts
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Thierry PEREZ, md
Role: primary
Other Identifiers
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2022-003784-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2022_0422
Identifier Type: -
Identifier Source: org_study_id