A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) (ORATOS)
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The purpose of the study is to evaluate the effect of BGF MDI compared with placebo MDI on cardiac and lung function when administered in participants diagnosed with COPD and hyperinflation.
Full description
This is a Phase IV, randomised, double blind, multiple centre, placebo controlled, crossover study where the effectiveness of BGF MDI in comparison with matching placebo MDI on cardiac and pulmonary function will be evaluated in patients with COPD and hyperinflation.
The study will comprise of:
- Screening period
- Participants will receive placebo inhaler and salbutamol before randomization
- Two treatment periods where participants will be randomized 1:1 to receive either the study intervention BGF MDI followed by matching placebo or study interventions in reverse order
- A final follow-up period
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
- Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.
- A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7.
- 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) ≥ 1.
- 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.
- All women of child bearing potential must have a negative pregnancy test at the Visit 1.
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
56 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
AstraZeneca Clinical Study Information Center
Data sourced from clinicaltrials.gov
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