BUDESONIDE, GLYCOPYRRONIUM BROMIDE, FORMOTEROL FUMARATE DIHYDRATE for Chronic obstructive pulmonary disease

Inclusion criteria

• {"criterion_text":"- Current or former smoker with a history of ≥ 10 pack-years of tobacco smoking.\n- A diagnosis of COPD confirmed by a post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) < 0.7.\n- At Visit 1: A pre-bronchodilator FEV1 < 80%.\n- 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.\n- At Visit 1: Modified Medical Research Council (mMRC) ≥ 1.\n- At Visit 2: A pre-bronchodilator functional residual capacity (FRC) of > 135% of predicted normal FRC.\n- At Visit 2: A post-bronchodilator FEV1 ≥ 30% and < 80% of the predicted normal value.\n- Participants must be on mono-, dual-, or triple-inhaled maintenance COPD treatment.\n- Female participants must either be not of childbearing potential or using a form of highly effective birth control.\n- All women of child bearing potential must have a negative pregnancy test at the Visit 1."}

Exclusion criteria

• {"criterion_text":"- 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.\n- History of a COPD exacerbation that required hospitalisation, or 2 or more COPD exacerbations that required systemic corticosteroids.\n- History of myocardial infarction or acute coronary syndrome.\n- History or current clinical significant atrial or ventricular arrhythmia to be confirmed by electrocardiogram (ECG).\n- Participants with a cardiac implantable electronic device, including pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy.\n- Participants with ECG QTcF interval at Visit 1 > 460 milliseconds (ms) for males and > 480 ms for females.\n- Participants who have had a respiratory tract infection within 8 weeks prior to Visit 1 and/or during the screening/run-in period.\n- Participants with lung lobectomy, lung volume reduction (during the study and within 3 months of Visit 1), or lung transplantation."}

Primary endpoints

• {"endpoint_text":"- Change from baseline in left ventricular end diastolic volume (LVEDVi) measured by magnetic resonance imaging (MRI).","definition_or_measurement_approach":"Measured by magnetic resonance imaging (MRI); change from baseline in LVEDVi."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in functional residual capacity/total lung capacity (FRC/TLC) measured by body plethysmography.","definition_or_measurement_approach":"Measured by body plethysmography; change from baseline in FRC/TLC."}
• {"endpoint_text":"- Change from baseline in residual volume/total lung capacity (RV/TLC) measured by body plethysmography","definition_or_measurement_approach":"Measured by body plethysmography; change from baseline in RV/TLC."}

Germany

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

240

Number Of Sites

4

Number Of Participants

20

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: 1,10,11,12,2,5,6,8,9; contact Clinicaltrial.Enquiries@parexel.com

Third parties

• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"Codes: 1,10,11,12,2,5,6,8,9","organisation_type":"Pharmaceutical company"}