2025-521987-37-00RecruitingPhase 4
A Randomised, Double-blind, Multi-centre, Placebo-controlled, Crossover Study to Assess the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler on Cardiac and Lung Function in Participants with Chronic Obstructive Pulmonary Disease and Hyperinflation (ORATOS)
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- AstraZeneca AB
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Change from baseline in left ventricular end diastolic volume (LVEDV) measured by magnetic resonance imaging (MRI).
Study Overview
Brief Summary
The effect of BGF relative to placebo on LVEDV in participants with COPD and hyperinflation will be evaluated
Study Design
- Allocation
- Randomized
- Primary Purpose
- Screening period/ Treatment Period/ Follow up
- Masking
- Double (Subject, Investigator)
Eligibility Criteria
- Ages
- 18 years to 65+ years (18-64 Years, 65+ Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
- •All women of child bearing potential must have a negative pregnancy test at the Visit
- •A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.
- •At Visit 1: A pre-bronchodilator FEV1 < 80%.
- •At Visit 1: Peripheral blood eosinophil count < 300 cells/cubic millimeter (mm³), with no recorded history of eosinophil count > 300 cells/mm³ in the past 12 months.
- •At Visit 1: Modified Medical Research Council (mMRC) ≥
- •At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of > 135% of predicted normal FRC.
- •At Visit 2: A post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value.
- •Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.
- •Female participants must either be not of childbearing potential or using a form of highly effective birth control.
Exclusion Criteria
- •A current diagnosis of asthma, asthma-COPD overlap, or any other chronic respiratory disease other than COPD, such as alpha-1 antitrypsin deficiency, active tuberculosis, lung cancer, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
- •History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.
- •History of myocardial infarction or acute coronary syndrome.
- •History or current atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).
- •Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.
- •Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.
- •Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.
- •Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation.
Outcomes
Primary Outcomes
Change from baseline in left ventricular end diastolic volume (LVEDV) measured by magnetic resonance imaging (MRI).
Change from baseline in left ventricular end diastolic volume (LVEDV) measured by magnetic resonance imaging (MRI).
Secondary Outcomes
- Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography.
- Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography
Investigators
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
Study Sites (3)
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