BUDESONIDE; GLYCOPYRRONIUM BROMIDE; FORMOTEROL FUMARATE DIHYDRATE for Chronic Obstructive Pulmonary Disease (COPD)

Inclusion criteria

• {"criterion_text":"- 1 Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF."}
• {"criterion_text":"- 9 Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments."}
• {"criterion_text":"- 2 Demonstrate acceptable MDI administration technique at Visit 1(V1) and Visit 2(V2) (randomization)"}
• {"criterion_text":"- 10 A female is eligible to enter and participate in the study if the female is of: • Non-childbearing potential: either permanently sterilized or who are post-menopausal. • Childbearing potential: has a negative serum pregnancy test at V1 and must use one highly effective form of birth control."}
• {"criterion_text":"- 11 Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol."}
• {"criterion_text":"- 3 A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70% predicted at V1."}
• {"criterion_text":"- 4 Current or former smokers with a history of at least 10 pack-years of cigarette smoking; defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to V1."}
• {"criterion_text":"- 5 A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory"}
• {"criterion_text":"- 6 A CAT score of ≥ 10 at Visit 1."}
• {"criterion_text":"- 7 Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b), (c), or (d)]. (a) Established CV (b) Combination of CV risk factors: • Hypertension • diabetes mellitus • chronic kidney disease• dyslipidemia • obesity (c) High risk of CV disease determined using an established CV risk assessment tool (d) CT coronary artery calcification"}
• {"criterion_text":"- 8 Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol."}

Exclusion criteria

• {"criterion_text":"- 1 Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension."}
• {"criterion_text":"- 10 Unable to abstain from protocol-defined prohibited medications"}
• {"criterion_text":"- 11 Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in this protocol is prohibited for use during the duration of the study)."}
• {"criterion_text":"- 12 Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI."}
• {"criterion_text":"- 13 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)."}
• {"criterion_text":"- 14 Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements."}
• {"criterion_text":"- 15 Previous randomization in the present study."}
• {"criterion_text":"- 16 For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding."}
• {"criterion_text":"- 2 End-stage renal disease requiring renal replacement therapy."}
• {"criterion_text":"- 3 History of heart or lung transplant or actively listed for heart or lung transplant."}
• {"criterion_text":"- 4 Implanted left ventricular assist device or implant anticipated in < 3 months."}
• {"criterion_text":"- 5 History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1."}
• {"criterion_text":"- 6 Unstable or life-threatening cardiac disease – participants with any of the following at Visit 1 would be excluded: (a) An MI or unstable angina in the last 8 weeks (b) Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks. NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event."}
• {"criterion_text":"- 7 Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1 (see Section 5.4 regarding rescreening or extension of run-in period)."}
• {"criterion_text":"- 8 Any life-threatening condition, including malignancy, with a life expectancy < 5 years, other than CV disease or COPD, that might prevent the participant from completing the study."}
• {"criterion_text":"- 9 Use of maintenance ICS treatment within the past 12 months."}

Primary endpoints

• {"endpoint_text":"- Time to first severe cardiac or COPD event.","definition_or_measurement_approach":"Not further defined in Part I document; endpoint expressed as time-to-event (time from randomization to first qualifying severe cardiac or COPD event)."}

Secondary endpoints

• {"endpoint_text":"- Time to first severe COPD exacerbation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to first severe cardiac event","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to cardiopulmonary death","definition_or_measurement_approach":""}
• {"endpoint_text":"- moderate/severe COPD exacerbation rate","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to MI hospitalization (or cardiac death)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Time to HF acute healthcare visit/hospitalization (or cardiac death)","definition_or_measurement_approach":""}

Methods

• Social media advertising (social media packet) — targeted digital ads and social media content to reach potential COPD patients (country-specific social media packets and ads prepared).
• Landing page / online landing page adverts — online landing pages for study information and sign-up; associated privacy policy and landing-page scripts provided.
• Hybrid prescreening screener (Part A / Part B) — online/remote pre-screening tools to identify eligible participants prior to site contact.
• Email templates and generic text emails — direct email outreach templates for contacting potential participants or clinics.
• Posters and leaflets — printed recruitment posters and patient leaflets for display/distribution at clinics and community locations.
• GP / healthcare letters and referral letters — letters to general practitioners/healthcare providers to inform and refer eligible patients.
• Site local adverts and patient-facing materials (patient cards, thank you cards, IFU booklets) — materials for onsite recruitment and patient information.
• Video materials / video script — script for informational videos to support recruitment and informed consent.
• Hybrid of virtual visits and onsite visits — protocol allows virtual visits; recruitment materials reference virtual participation options.

Primary sponsor

Full Name

Astrazeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden