Phase
Condition
Copd (Chronic Obstructive Pulmonary Disease)
Treatment
BGF MDI HFO 320/14.4/9.6μg
BGF MDI HFA 320/14.4/9.6 μg
Placebo MDI HFA
Clinical Study ID
Ages 40-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
Age
Participants must be 40 to 80 years inclusive at the time of signing the ICF. Typeof Participant and Disease Characteristics
Participants who have a documented history of physician-diagnosed COPD as defined bythe ATS/ERS (Celli et al 2004).
Participants who have been receiving LABA, LAMA, LAMA/LABA, or ICS/LABA inhaledmaintenance therapies for the management of their COPD for at least 4 weeks prior toVisit 1, OR Participants who have been receiving SABA, SAMA, or SABA/SAMA eitherscheduled or as needed for at least 4 weeks prior to Visit 1, OR Participants whoare COPD treatment-naïve or have not received previously prescribed COPD treatmentin the 4 weeks prior to Visit 1.
At Visit 1: Participants with a blood eosinophil count < 300 cells/μL.
At Visit 1: Participants with a pre-bronchodilator FEV1 of < 80% predicted normal.
At Visit 2: Participants with a post-bronchodilator FEV1/FVC ratio of < 0.70 and apostbronchodilator FEV1 of ≥ 40% to < 80% predicted normal.
At Visit 3 (TP 1 Day 1): Participants with a pre-dose FEV1 of < 80% predicted normalthat is within ± 20% or 200 mL of their Visit 2 pre-bronchodilator FEV1 and anFEV1/FVC ratio of < 0.70.
Current or former smokers with a history of at least 10 pack-years of tobaccosmoking
pack-year = 20 cigarettes smoked per day for one year). 9 Participants who arewilling and, in the opinion of the Investigator, able to adjust current COPDtherapy, as required by the protocol. Sex and Contraceptive/Barrier Requirements 10Females must not be of childbearing potential or must use a form of highly effectivebirth control as defined below:
Females not of childbearing potential are defined as females who are eitherpermanently sterilised (hysterectomy, bilateral oophorectomy, or bilateralsalpingectomy) or postmenopausal. Females will be considered postmenopausal ifthey have been amenorrhoeic for 52 weeks (12 months) prior to the planned dateof randomisation without an alternative medical cause. The followingage-specific requirements apply:
Females < 50 years old would be considered postmenopausal if they havebeen amenorrhoeic for 52 weeks (12 months) or more following cessation ofexogenous hormonal treatment with FSH levels in the postmenopausal range.
Females ≥ 50 years old would be considered postmenopausal if they havebeen amenorrhoeic for 52 weeks (12 months) or more following cessation ofall exogenous hormonal treatment.
Female participants of childbearing potential must use one highly effectiveform of birth control. A highly effective method of contraception is defined asone that can achieve a failure rate of less than 1% per year when usedconsistently and correctly. All FOCBP who are sexually active with a non-sterilised male partner must agree touse one highly effective method of birth control, as defined below, from enrolmentthroughout the study and until at least 14 days after the last dose of studyintervention. Cessation of contraception after this point should be discussed with aresponsible physician. Periodic abstinence (calendar, symptothermal, post-ovulationmethods), withdrawal (coitus interruptus), spermicides only, and lactational [15:32] Łubian, Dominika amenorrhoea method are not acceptable methods of contraception.Female condom and male condom should not be used together.
All FOCBP must have a negative serum pregnancy test result at Visit 1.
Females < 50 years of age with amenorrhoea for at least 12 months without analternative medical cause must have a serum FSH test at Visit 1.
Highly effective birth control methods are listed below:
Total sexual abstinence is an acceptable method provided it is thepreferred and usual lifestyle of the participant (defined as refrainingfrom heterosexual intercourse during the entire period of risk associatedwith the study interventions).
Combined (oestrogen and progestogen-containing) hormonal contraceptionassociated with inhibition of ovulation:o Oralo Intravaginalo Transdermal
Progestogen-only hormonal contraception associated with inhibition ofovulation: o Oral o Injectable
Implantable
Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Male partner sterilisation/vasectomy with documentation of azoospermiaprior to the female participant's entry into the study, and this male isthe sole partner for that participant. The documentation on male sterilitycan come from the site personnel's review of participant's medicalrecords, medical examination and/or semen analysis or medical historyinterview provided by her or her partner. Informed Consent 11 Capable ofgiving signed informed consent as described in Appendix A which includescompliance with the requirements and restrictions listed in the ICF and inthis protocol. Other Inclusion Criteria 12 Participants with calculated eGFR > 30 mL/min/1.73 m2using the CKD-EPI formula.
13 Participants who demonstrate acceptable MDI administration and spirometry techniques.
14 Participants who remain compliant with placebo run-in administrations, defined as ≥ 80% of planned doses over the last 7 days prior to Visit 3, based on ePRO diary data.
15 Participants who are willing to remain at the study centre as required per protocol to complete all visit assessments.
Exclusion
Exclusion Criteria:
Medical Conditions
Confirmed diagnosis of asthma, in the opinion of the Investigator based on thoroughreview of medical history and medical records.
COPD due to α1-antitrypsin deficiency.
A COPD exacerbation treated with systemic corticosteroids or antibiotics within 4months prior to Visit 1 or during the Screening Period.
A COPD exacerbation that required hospitalisation within 12 months prior to Visit 1or during the Screening Period.
A respiratory infection ending within 4 weeks prior to Visit 1 or beginning orending during the Screening Period, per the Investigator's judgement.
Life-threatening COPD (eg, need for mechanical ventilation) at any time prior toVisit 1 or during the Screening Period.
A SARS-CoV-2 infection in the 8 weeks prior to Visit 1 or during the ScreeningPeriod, or that required hospitalisation at any time prior to Visit 1 or during theScreening Period.
Sleep apnoea that, in the opinion of the Investigator, is uncontrolled.
Other respiratory disorders including, but not limited to, known activetuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high-resolution CT evidence of bronchiectasis that causes repeated acuteexacerbations), severe neurological disorders affecting control of the upper airway,sarcoidosis, primary ciliary dyskinesia, idiopathic interstitial pulmonary fibrosis,primary pulmonary hypertension, or pulmonary thromboembolic disease.
Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heartfailure, uncontrolled hypertension as defined by the Investigator, or any otherrelevant cardiovascular disorder as judged by the Investigator.
Diagnosis of narrow-angle glaucoma that has not been adequately treated, or a changein vision that may be relevant, in the opinion of the Investigator. Note: All medications approved for control of intraocular pressures are allowed,including topical ophthalmic nonselective beta-blockers and prostaglandin analogues.
Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retentionthat, in the opinion of the Investigator, is clinically significant.
Unresectable cancer that has not been in complete remission for at least 5 yearsprior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin areallowed.
Historical or current evidence of a clinically significant disease including, butnot limited to: cardiovascular, hepatic, renal, haematological, neurological,endocrine, gastrointestinal, or pulmonary. Immune deficiency disorders (ie, HIVinfection) should be excluded even if controlled. Significant is defined as anydisease that, in the opinion of the Investigator, would put the safety of theparticipant at risk through participation, or that could affect the efficacy orsafety analysis if the disease/condition is exacerbated during the study.
Participants with a known hypersensitivity to beta2-agonists, muscarinicantagonists, or corticosteroids, or any component of the MDI.
Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse atany time during the study.
History of QT prolongation associated with another medication that requireddiscontinuation of that medication. Prior/Concomitant Therapy
Unable to abstain from short-acting bronchodilators within 6 hours prior to lungfunction testing at each study visit.
Pulmonary resection or lung volume reduction surgery during the 6 months prior toVisit 1 (ie, lobectomy, bronchoscopic lung volume reduction [endobronchial blockers,airway bypass, endobronchial valves, thermal vapour ablation, biological sealants,and airway implants]).
Long-term-oxygen therapy or nocturnal oxygen therapy required for greater than 15hours per day. Note: As-needed oxygen use is allowed.
Trans-urethral resection of the prostate or full resection of the prostate within 6months prior to Visit 1.
Unable to abstain from any protocol-defined prohibited medications during theScreening or Treatment Periods (see Section 6.9).
Use of any herbal products by either inhalation or nebuliser within 2 weeks prior toVisit 1 or refusal to stop use for the duration of the study. Prior/Concurrent Clinical Study Experience
Participation in another clinical study with a study intervention administeredwithin 30 days or 5 half-lives, whichever is longer, prior to Visit 1. Diagnostic Assessments
Participants with ECG QTcF interval > 480 milliseconds.
Participants with high-degree atrioventricular block II or III, or with sinus nodedysfunction with clinically significant pauses who are not treated with pacemaker.
Any clinically relevant abnormal findings in physical examination, clinicalchemistry, haematology, urinalysis, vital signs, or ECG which, in the opinion of theInvestigator, may put the participant at risk because of their participation in thestudy. Other Exclusions
Planned hospitalisation during the study.
Involvement in the planning or conduct of the study (applies to both AstraZenecastaff and staff at the study sites).
Study Investigators, sub-Investigators, coordinators, and their employees orimmediate family members.
Judgement by the Investigator that the participant should not participate in thestudy if the participant is unlikely to comply with study procedures, restrictions,and requirements.
Previous randomisation in the present study.
For women only: currently pregnant (confirmed with positive pregnancy test),breastfeeding, or planned pregnancy during the study, or FOCBP not using acceptablecontraception measures.
Study Design
Study Description
Connect with a study center
Research Site
Buenos Aires, C1425BEN
ArgentinaActive - Recruiting
Research Site
Quilmes, B1878FNR
ArgentinaActive - Recruiting
Research Site
Rosario, S2000DEJ
ArgentinaActive - Recruiting
Research Site
San Fernando, B1646EBJ
ArgentinaActive - Recruiting
Research Site
Burgas, 8000
BulgariaActive - Recruiting
Research Site
Dupnitsa, 2600
BulgariaSite Not Available
Research Site
Pernik, 2300
BulgariaActive - Recruiting
Research Site
Pleven, 5800
BulgariaActive - Recruiting
Research Site
Plovdiv, 4002
BulgariaActive - Recruiting
Research Site
Ruse, 7002
BulgariaSite Not Available
Research Site
Sofia, 1606
BulgariaSite Not Available
Research Site
Varna, 9000
BulgariaActive - Recruiting
Research Site
Veliko Tarnovo, 5000
BulgariaActive - Recruiting
Research Site
Vratsa, 3000
BulgariaActive - Recruiting
Research Site
Truro, Nova Scotia B2N 1L2
CanadaActive - Recruiting
Research Site
Burlington, Ontario L7N 3V2
CanadaActive - Recruiting
Research Site
Guelph, Ontario N1H 6J2
CanadaActive - Recruiting
Research Site
St Charles Borromee, Quebec J6E 2B4
CanadaActive - Recruiting
Research Site
Quebec, G1W 4R4
CanadaActive - Recruiting
Research Site
Balassagyarmat, 2660
HungaryActive - Recruiting
Research Site
Budapest, 1204
HungarySite Not Available
Research Site
Gödöllő, 2100
HungarySite Not Available
Research Site
Hajdúnánás, 4080
HungaryActive - Recruiting
Research Site
Mosonmagyaróvár, 9200
HungaryActive - Recruiting
Research Site
Pécs, 7635
HungaryActive - Recruiting
Research Site
Püspökladány, 4150
HungaryActive - Recruiting
Research Site
Ajmer, 305001
IndiaActive - Recruiting
Research Site
Aligarh, 202002
IndiaActive - Recruiting
Research Site
Coimbatore, 641028
IndiaActive - Recruiting
Research Site
Jaipur, 302039
IndiaActive - Recruiting
Research Site
Kanpur, 208002
IndiaActive - Recruiting
Research Site
Mangalore, 575003
IndiaSite Not Available
Research Site
Surat, 395009
IndiaActive - Recruiting
Research Site
Daegu, 42415
Korea, Republic ofActive - Recruiting
Research Site
Jeonju, 54907
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 06591
Korea, Republic ofActive - Recruiting
Research Site
Ulsan, 44033
Korea, Republic ofActive - Recruiting
Research Site
George Town, 10450
MalaysiaActive - Recruiting
Research Site
Ipoh, 30990
MalaysiaActive - Recruiting
Research Site
Kuala Lumpur, 50586
MalaysiaActive - Recruiting
Research Site
Kuala Terengganu, 20400
MalaysiaActive - Recruiting
Research Site
Benito Juarez, 03650
MexicoActive - Recruiting
Research Site
Chihuahua, 31200
MexicoActive - Recruiting
Research Site
Cuernavaca, 62290
MexicoSite Not Available
Research Site
Merida, 97000
MexicoSite Not Available
Research Site
Monterrey, 64465
MexicoActive - Recruiting
Research Site
Zapopan, 45138
MexicoActive - Recruiting
Research Site
Iloilo City, 5000
PhilippinesActive - Recruiting
Research Site
Las Pinas, 1742
PhilippinesActive - Recruiting
Research Site
Manila, 1000
PhilippinesSite Not Available
Research Site
Quezon City, 1000
PhilippinesSuspended
Research Site
Białystok, 15-044
PolandActive - Recruiting
Research Site
Chęciny, 26-060
PolandActive - Recruiting
Research Site
Jelenia Góra, 58-506
PolandActive - Recruiting
Research Site
Lublin, 20-601
PolandActive - Recruiting
Research Site
Sosnowiec, 41-208
PolandSuspended
Research Site
Chiang Mai, 50200
ThailandActive - Recruiting
Research Site
Hat Yai, 90110
ThailandActive - Recruiting
Research Site
Khon Kaen, 40002
ThailandActive - Recruiting
Research Site
Muang, 22000
ThailandActive - Recruiting
Research Site
Ankara, 06620
TurkeyActive - Recruiting
Research Site
Dinar, 03400
TurkeyActive - Recruiting
Research Site
Istanbul, 34722
TurkeyActive - Recruiting
Research Site
Izmir, 35965
TurkeyActive - Recruiting
Research Site
Kayseri, 38039
TurkeyActive - Recruiting
Research Site
Sheffield, Alabama 35660
United StatesActive - Recruiting
Research Site
Northridge, California 91324
United StatesSite Not Available
Research Site
Clearwater, Florida 33765
United StatesActive - Recruiting
Research Site
Gainesville, Florida 32605
United StatesActive - Recruiting
Research Site
Miami, Florida 33175
United StatesActive - Recruiting
Research Site
Orlando, Florida 32825
United StatesActive - Recruiting
Research Site
Tampa, Florida 33606
United StatesActive - Recruiting
Research Site
Rincon, Georgia 31326
United StatesActive - Recruiting
Research Site
Chicago, Illinois 60607
United StatesActive - Recruiting
Research Site
Nottingham, Maryland 21236
United StatesActive - Recruiting
Research Site
Saint Charles, Missouri 63301
United StatesActive - Recruiting
Research Site
Saint Louis, Missouri 63141
United StatesActive - Recruiting
Research Site
Bronx, New York 10455
United StatesActive - Recruiting
Research Site
Raleigh, North Carolina 27607
United StatesActive - Recruiting
Research Site
Dublin, Ohio 43016
United StatesActive - Recruiting
Research Site
Grove City, Ohio 43123
United StatesSite Not Available
Research Site
Medford, Oregon 97504
United StatesActive - Recruiting
Research Site
Portland, Oregon 97202
United StatesActive - Recruiting
Research Site
Philadelphia, Pennsylvania 19114
United StatesActive - Recruiting
Research Site
Gaffney, South Carolina 29340
United StatesActive - Recruiting
Research Site
Boerne, Texas 78006
United StatesActive - Recruiting
Research Site
El Paso, Texas 79912
United StatesActive - Recruiting
Research Site
Can Tho, 900000
VietnamActive - Recruiting
Research Site
Da Nang, 550000
VietnamActive - Recruiting
Research Site
Ha Noi, 100000
VietnamActive - Recruiting
Research Site
Hai Phong, 180000
VietnamActive - Recruiting
Research Site
Hanoi, 100000
VietnamActive - Recruiting
Research Site
Ho Chi Minh, 700000
VietnamActive - Recruiting
Research Site
Hochiminh, 70000
VietnamActive - Recruiting
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