Clinical Trials List
Protocol NumberD7860C00006
Active
2025-06-01 - 2028-12-31
Phase II
Recruiting10
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 4-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO)
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Trial Applicant
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Sponsor
AstraZeneca Taiwan Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 簡格凌 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 林倡葦 Division of Thoracic Medicine
- Ko-Wei Chang Division of Thoracic Medicine
- 羅友倫 Division of Thoracic Medicine
- 王才郁 Division of Thoracic Medicine
- Shu-Min Lin Division of Thoracic Medicine
- 羅君禹 Division of Thoracic Medicine
- 林定佑 Division of Thoracic Medicine
- 胡漢忠 Division of Thoracic Medicine
- 謝孟亨 Division of Thoracic Medicine
- Jia-Shiuan Ju Division of Thoracic Medicine
- Horng-Chyuan Lin Division of Thoracic Medicine
- 黃建達 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHUN-TA HUANG Division of Thoracic Medicine
- 錢穎群 Division of Thoracic Medicine
- 黃俊凱 Division of Thoracic Medicine
- 鐘桂彬 Division of Thoracic Medicine
- 阮聖元 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chien Cheng Division of Thoracic Medicine
- Chia-Hsiang Li Division of Thoracic Medicine
- Shuo-Chueh Chen Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳正雄 Division of Thoracic Medicine
- 蔡偉宏 Division of Thoracic Medicine
- 林明泰 Division of Thoracic Medicine
- 施穎銘 Division of Thoracic Medicine
- 黃國揚 Division of Thoracic Medicine
- 林聖皓 Division of Thoracic Medicine
- 張時榮 Division of Thoracic Medicine
- 詹博強 Division of Thoracic Medicine
- 林俊維 Division of Thoracic Medicine
- 紀炳銓 Division of Thoracic Medicine
- 葉金水 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Hsin Lee Division of Thoracic Medicine
- Yu-Tien Tzeng Division of Thoracic Medicine
- Kuan-Jen Bai Division of Thoracic Medicine
- Shian-Jiun Lin Division of Thoracic Medicine
- 楊善堯 Division of Thoracic Medicine
- 江振源 Division of Thoracic Medicine
- Han-Lin Hsu Division of Thoracic Medicine
- 石智元 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Chau-Chyun Sheu
Co-Principal Investigator
- Wei-An Chang
- jong rung Tsai
- Inn-Wen Chong Division of Thoracic Medicine
- 莊政皓
- Ming-Ju Tsai
- 張旭良
- Hung-Ling Huang
- 鄭孟軒 Division of Thoracic Medicine
- 陳家閔
- 鄭至宏
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic Obstructive Pulmonary Disease (COPD)
Objectives
The purpose of this study is to evaluate the exacerbation rate of AZD6793 compared with placebo tablets in subjects with moderate to very severe chronic obstructive pulmonary disease (COPD).
Test Drug
Tablet
Active Ingredient
AZD6793
Dosage Form
110
Dosage
N/A
Endpoints
To evaluate the effect of AZD6793 compared with placebo on the exacerbation rate in subjects with moderate or severe chronic obstructive pulmonary disease (COPD).
Inclution Criteria
Key Inclusion Criteria
Subjects are eligible for participation in this study only if all of the following criteria are met:
Age
Subjects must be ≥ 40 years of age at the time of signing the informed consent form (ICF).
Subject Type and Disease Characteristics
Documented diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD) for at least 12 months prior to enrollment.
At Visit 1, pre-bronchodilator (BD) forced expiratory volume in one second (FEV₁)/forced vital capacity (FVC) < 0.7; and at Visit 2, both pre- and post-BD FEV₁/FVC < 0.7, with post-BD FEV₁ ≥ 25% and < 80% of predicted normal value. If pre-BD FEV₁/FVC ≥ 0.7, post-BD spirometry should not be performed.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to screening (Visit 1). Subjects with 1 documented moderate exacerbation within the same period may be eligible, limited to 20% of total enrollment.
Acceptable documentation includes:
(a) Office or specialist consultation notes, emergency room or hospital records confirming a COPD exacerbation;
(b) Prescription records for ≥ 3 days of systemic corticosteroids (or one long-acting injectable dose) and/or antibiotics for the treatment of COPD exacerbation; self-management prescriptions may be accepted if appropriately documented;
(c) Hospital discharge summaries confirming hospitalization or treatment with systemic corticosteroids/antibiotics due to COPD exacerbation;
(d) Pharmacy records showing dispensation of systemic corticosteroids (≥ 3 days or one long-acting injection) and/or antibiotics.
Documented stable triple or dual inhaled maintenance therapy for ≥ 3 months prior to screening (Visit 1).
Triple therapy may include inhaled corticosteroid (ICS) + long-acting β₂-agonist (LABA) + long-acting muscarinic antagonist (LAMA).
Dual therapy (ICS + LABA, ICS + LAMA, or LABA + LAMA) is permitted if triple therapy or ICS is deemed unsuitable by the treating physician (e.g., repeated eosinophil count ≤ 100 cells/mL, or significant ICS-related adverse events such as prior pneumonia or oral candidiasis).
Both single-inhaler and fixed-dose combination inhalers are acceptable; documentation of prescription and/or medication must be provided.
Change of inhaler device or component substitution is allowed if dose equivalence and class consistency are maintained.
Short-acting muscarinic antagonist (SAMA) used routinely (≥ 3 times per day) is considered equivalent to LAMA therapy.
Any oral COPD maintenance medications (e.g., azithromycin, roflumilast) must also be stable for ≥ 3 months prior to screening.
COPD Assessment Test (CAT) score ≥ 10 at Visit 1.
Current or former smokers with a ≥ 10 pack-year smoking history.
Pack-years = (average cigarettes per day ÷ 20) × years smoked.
Former smokers: not currently smoking and abstinent for ≥ 6 months prior to screening with intent to remain abstinent.
E-cigarette and heated tobacco product use is not counted toward pack-year history.
Clinically stable (no COPD exacerbation for ≥ 4 weeks prior to Visit 1) and remains exacerbation-free until randomization (Visit 3).
Willing to continue current COPD maintenance therapy throughout the study (except in case of adverse events requiring modification).
Women of childbearing potential (WOCBP) must have negative pregnancy tests at Visits 1 and 3.
≥ 70% adherence to COPD maintenance medication during the 2 weeks prior to Visit 3.
≥ 70% compliance with patient-reported outcome (PRO) diary completion during the last 14 days of the screening period (≥ 10 of 14 evenings completed before randomization).
Able to read, write, and use an electronic device.
Body Weight
Body mass index (BMI) between 18.0 and 44.9 kg/m², inclusive.
Sexual Behavior and Contraception Requirements
Women not of childbearing potential (WNOCBP): defined as permanently sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal per the following:
< 50 years old: amenorrheic ≥ 12 months after discontinuing exogenous hormones, with FSH levels in postmenopausal range.
≥ 50 years old: amenorrheic ≥ 12 months after discontinuing all exogenous hormones.
Contraception requirements for participants of childbearing potential must comply with local regulatory guidance for clinical trial participants.
All WOCBP with non-sterilized male partners must agree to use a highly effective contraceptive method (failure rate < 1%) throughout the treatment period and for 2 weeks after the last dose of investigational medicinal product (IMP).
Male participants with WOCBP partners must agree to use condoms from randomization until 2 weeks after the last IMP dose, and their partners must use a highly effective contraceptive method as well.
WOCBP must have been on a stable approved contraceptive method for ≥ 3 months before Visit 3, continuing through the treatment period and for 2 weeks post-treatment.
Highly effective contraceptive methods include:
Non-hormonal methods:
Complete abstinence (as a consistent lifestyle choice)
Vasectomized partner (confirmed azoospermia)
Bilateral tubal occlusion (failure rate > 1%)
Copper intrauterine device (IUD)
Hormonal methods:
Levonorgestrel intrauterine system (IUS)
Medroxyprogesterone injection
Combined oral or transdermal contraceptives (ethinylestradiol + progestin)
Vaginal ring (ethinylestradiol + etonogestrel)
Hormone-releasing intrauterine system
Unacceptable methods include:
Periodic abstinence (calendar, ovulation, symptothermal methods)
Withdrawal (coitus interruptus)
Spermicides alone
Lactational amenorrhea method (LAM)
Female condoms
Informed Consent
Ability to provide a signed informed consent form (ICF) as described in Appendix A, including agreement to comply with study procedures and restrictions.
Must provide signed and dated written informed consent prior to any study-specific procedures, sample collection, or analyses.
Must provide optional signed and dated consent for genomic research sample collection to support the genomic substudy (Appendix D2); not applicable to participants in China.
Must provide signed and dated consent for the High-Resolution Computed Tomography (HRCT) substudy, if applicable (Appendix G1).
Must provide signed and dated consent for the Patient Experience Interview substudy, if applicable (Appendix G6).
Subjects are eligible for participation in this study only if all of the following criteria are met:
Age
Subjects must be ≥ 40 years of age at the time of signing the informed consent form (ICF).
Subject Type and Disease Characteristics
Documented diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD) for at least 12 months prior to enrollment.
At Visit 1, pre-bronchodilator (BD) forced expiratory volume in one second (FEV₁)/forced vital capacity (FVC) < 0.7; and at Visit 2, both pre- and post-BD FEV₁/FVC < 0.7, with post-BD FEV₁ ≥ 25% and < 80% of predicted normal value. If pre-BD FEV₁/FVC ≥ 0.7, post-BD spirometry should not be performed.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to screening (Visit 1). Subjects with 1 documented moderate exacerbation within the same period may be eligible, limited to 20% of total enrollment.
Acceptable documentation includes:
(a) Office or specialist consultation notes, emergency room or hospital records confirming a COPD exacerbation;
(b) Prescription records for ≥ 3 days of systemic corticosteroids (or one long-acting injectable dose) and/or antibiotics for the treatment of COPD exacerbation; self-management prescriptions may be accepted if appropriately documented;
(c) Hospital discharge summaries confirming hospitalization or treatment with systemic corticosteroids/antibiotics due to COPD exacerbation;
(d) Pharmacy records showing dispensation of systemic corticosteroids (≥ 3 days or one long-acting injection) and/or antibiotics.
Documented stable triple or dual inhaled maintenance therapy for ≥ 3 months prior to screening (Visit 1).
Triple therapy may include inhaled corticosteroid (ICS) + long-acting β₂-agonist (LABA) + long-acting muscarinic antagonist (LAMA).
Dual therapy (ICS + LABA, ICS + LAMA, or LABA + LAMA) is permitted if triple therapy or ICS is deemed unsuitable by the treating physician (e.g., repeated eosinophil count ≤ 100 cells/mL, or significant ICS-related adverse events such as prior pneumonia or oral candidiasis).
Both single-inhaler and fixed-dose combination inhalers are acceptable; documentation of prescription and/or medication must be provided.
Change of inhaler device or component substitution is allowed if dose equivalence and class consistency are maintained.
Short-acting muscarinic antagonist (SAMA) used routinely (≥ 3 times per day) is considered equivalent to LAMA therapy.
Any oral COPD maintenance medications (e.g., azithromycin, roflumilast) must also be stable for ≥ 3 months prior to screening.
COPD Assessment Test (CAT) score ≥ 10 at Visit 1.
Current or former smokers with a ≥ 10 pack-year smoking history.
Pack-years = (average cigarettes per day ÷ 20) × years smoked.
Former smokers: not currently smoking and abstinent for ≥ 6 months prior to screening with intent to remain abstinent.
E-cigarette and heated tobacco product use is not counted toward pack-year history.
Clinically stable (no COPD exacerbation for ≥ 4 weeks prior to Visit 1) and remains exacerbation-free until randomization (Visit 3).
Willing to continue current COPD maintenance therapy throughout the study (except in case of adverse events requiring modification).
Women of childbearing potential (WOCBP) must have negative pregnancy tests at Visits 1 and 3.
≥ 70% adherence to COPD maintenance medication during the 2 weeks prior to Visit 3.
≥ 70% compliance with patient-reported outcome (PRO) diary completion during the last 14 days of the screening period (≥ 10 of 14 evenings completed before randomization).
Able to read, write, and use an electronic device.
Body Weight
Body mass index (BMI) between 18.0 and 44.9 kg/m², inclusive.
Sexual Behavior and Contraception Requirements
Women not of childbearing potential (WNOCBP): defined as permanently sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or postmenopausal per the following:
< 50 years old: amenorrheic ≥ 12 months after discontinuing exogenous hormones, with FSH levels in postmenopausal range.
≥ 50 years old: amenorrheic ≥ 12 months after discontinuing all exogenous hormones.
Contraception requirements for participants of childbearing potential must comply with local regulatory guidance for clinical trial participants.
All WOCBP with non-sterilized male partners must agree to use a highly effective contraceptive method (failure rate < 1%) throughout the treatment period and for 2 weeks after the last dose of investigational medicinal product (IMP).
Male participants with WOCBP partners must agree to use condoms from randomization until 2 weeks after the last IMP dose, and their partners must use a highly effective contraceptive method as well.
WOCBP must have been on a stable approved contraceptive method for ≥ 3 months before Visit 3, continuing through the treatment period and for 2 weeks post-treatment.
Highly effective contraceptive methods include:
Non-hormonal methods:
Complete abstinence (as a consistent lifestyle choice)
Vasectomized partner (confirmed azoospermia)
Bilateral tubal occlusion (failure rate > 1%)
Copper intrauterine device (IUD)
Hormonal methods:
Levonorgestrel intrauterine system (IUS)
Medroxyprogesterone injection
Combined oral or transdermal contraceptives (ethinylestradiol + progestin)
Vaginal ring (ethinylestradiol + etonogestrel)
Hormone-releasing intrauterine system
Unacceptable methods include:
Periodic abstinence (calendar, ovulation, symptothermal methods)
Withdrawal (coitus interruptus)
Spermicides alone
Lactational amenorrhea method (LAM)
Female condoms
Informed Consent
Ability to provide a signed informed consent form (ICF) as described in Appendix A, including agreement to comply with study procedures and restrictions.
Must provide signed and dated written informed consent prior to any study-specific procedures, sample collection, or analyses.
Must provide optional signed and dated consent for genomic research sample collection to support the genomic substudy (Appendix D2); not applicable to participants in China.
Must provide signed and dated consent for the High-Resolution Computed Tomography (HRCT) substudy, if applicable (Appendix G1).
Must provide signed and dated consent for the Patient Experience Interview substudy, if applicable (Appendix G6).
Exclusion Criteria
If any of the following conditions apply, the subject must not participate in the study:
Medical conditions
Clinically significant pulmonary diseases other than COPD (e.g., asthma [based on a current diagnosis per the Global Initiative for Asthma (GINA) or other acceptable criteria], active pulmonary infection, clinically significant bronchiectasis [when bronchiectasis is the primary diagnosis], pulmonary fibrosis, cystic fibrosis, obesity hypoventilation syndrome, lung cancer, α-1 antitrypsin deficiency, or primary ciliary dyskinesia). Subjects with a prior misdiagnosis of asthma or a history of asthma are not excluded.
Radiological evidence of a respiratory disease other than COPD that clearly accounts for the subject’s respiratory symptoms.
(a) Radiologic findings suggestive of lung nodules suspicious for lung cancer (per applicable guidance such as The American College of Radiology Lung CT Screening Reporting and Data System [ACR Lung-RADS v2022]; Christensen et al., 2024) that have not been appropriately followed up before Visit 3.
(b) Recent pulmonary imaging findings requiring immediate diagnostic investigation or follow-up. If repeat surveillance imaging has been performed and the abnormality is deemed low risk for malignancy, the subject may be eligible. This also applies to subjects participating in the optional HRCT substudy.
Any unstable disease deemed by the investigator that may involve, but is not limited to, cardiovascular (CV), gastrointestinal, hepatic, renal, neurologic, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, major physiological, and/or cognitive disorders that:
(a) Affect subject safety during the study;
(b) Impact study findings or their interpretation; or
(c) Interfere with the subject’s ability to complete the study or comply with visit schedules and procedures.
Subjects with the following medical conditions:
(a) Significant left heart failure (i.e., New York Heart Association [NYHA] Class III or IV, or left ventricular ejection fraction <40% by echocardiogram or cardiac MRI [if available]).
(b) Unstable angina, acute coronary syndrome/myocardial infarction, percutaneous coronary intervention/coronary artery bypass grafting within 6 months prior to randomization, poorly controlled arrhythmias, cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary edema or fluid overload.
(c) Pulmonary hypertension that is idiopathic or secondary to connective tissue or thromboembolic disease.
Note: Subjects with pulmonary hypertension due to chronic lung disease may be eligible.
(d) History of conditions predisposing to infection (e.g., splenectomy, known primary or secondary immunodeficiency syndromes).
(e) History of ulcerative colitis, Crohn’s disease, or microscopic colitis confirmed by a gastroenterologist or histopathology.
(f) At baseline (Visit 3), >10% body surface area (BSA) depigmentation (e.g., vitiligo or other causes of depigmentation) as determined by the investigator. See Appendix H for regional BSA reference charts.
Abnormal laboratory results at screening:
(a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × upper limit of normal (ULN)
(b) Total bilirubin (TBL) >2 × ULN (unless due to Gilbert’s syndrome)
(c) Hemoglobin (Hb) <120 g/L (males); <110 g/L (females)
(d) White blood cell (WBC) count < lower limit of normal (LLN), absolute neutrophil count <2.5 × 10⁹/L, or platelet count <150 × 10⁹/L
(e) Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m² per CKD-EPI formula.
Note: Abnormal lab values may be retested once during screening (unless sample clotted, delayed, mishandled, or suspected lab error, in which case additional retesting is allowed).
Clinically significant abnormalities on a 12-lead ECG that, in the investigator’s judgment, increase subject risk. Atrial fibrillation is not exclusionary if heart rate is well-controlled and the subject has been on stable anticoagulation for ≥8 weeks.
Evidence of active and/or chronic liver disease. Subjects meeting any of the following will be excluded:
(a) Positive hepatitis C antibody unless hepatitis C virus (HCV) RNA is undetectable before randomization (for those previously treated for HCV, RNA assessment must be ≥12 weeks post-therapy).
(b) Positive hepatitis B surface antigen or history of hepatitis B infection. Subjects with a history of hepatitis B vaccination and no infection history may be included.
History or positive test for human immunodeficiency virus (HIV).
Clinically significant infection (viral, bacterial, or fungal) requiring systemic antimicrobial therapy >7 days within 4 weeks before Day 1 (Visit 3), including unexplained diarrhea, or clinically suspected infection at dosing. Subjects may be rescreened after resolution.
Prior lung volume reduction surgery.
History of bronchial thermoplasty or endobronchial valve placement within 6 months before Visit 1.
Use or requirement of long-term non-invasive positive pressure ventilation (NIPPV). Stable use of non-invasive ventilation for obstructive sleep apnea is allowed.
Current or past malignancy within 5 years before screening, except for:
(a) Low-risk prostate cancer under active surveillance;
(b) Completely treated cervical carcinoma in situ;
(c) Successfully treated ductal carcinoma in situ or localized medullary thyroid carcinoma with ≥1 year disease-free interval;
(d) Basal cell or superficial squamous cell skin cancers.
History of drug or alcohol abuse within 1 year prior to screening, or evidence suggesting such history.
Active or latent tuberculosis (TB) without completion of appropriate treatment or ongoing prophylaxis, as determined per local standard of care, potentially including history, physical exam, chest X-ray, or TB tests (e.g., PPD or QuantiFERON®).
Male or female subjects intending to become pregnant or donate sperm/eggs during the study or within 2 weeks after the last dose of IMP.
Prior/concomitant therapy
17. Current treatment with non-approved COPD background therapies (except nicotine vapor products or patches).
18. Major surgery within 8 weeks prior to screening or planned hospitalization for surgery during the study.
19. Treatment with broad-spectrum antibiotics (excluding chronic azithromycin) within 28 days prior to randomization (Visit 3).
20. Blood donation or blood product donation within 3 months before screening.
21. History of allogeneic bone marrow transplantation.
22. Initiation of a COPD rehabilitation program during the study. Subjects who have completed such a program may be enrolled immediately; maintenance participation is allowed.
23. Use of any prohibited concomitant medications as specified in the Clinical Study Protocol (CSP):
(a) Acute systemic (oral or injectable) corticosteroids within 28 days before Visit 1.
(b) Any other immunosuppressive therapy (e.g., methotrexate, cyclosporine, tacrolimus, azathioprine, or maintenance systemic corticosteroids) within 3 months before randomization. A ≤8-week course for acute/self-limited conditions is permitted but must end ≥4 weeks before Visit 1.
(c) Immunoglobulins, interferon-γ, or blood products within 28 days before Visit 1.
(d) Specific CYP-interacting drugs within 14 days before Visit 3 (see Table 8 for list).
(e) Metformin within 14 days before randomization.
(f) IMP within 4 months or 5 half-lives (whichever is longer) before randomization.
(g) Marketed biologics for respiratory disease within 4 months or 5 half-lives (whichever is longer) before consent.
Note: Subjects receiving stable marketed biologics ≥8 weeks for non-respiratory conditions (e.g., osteoporosis, migraine, pain, diabetes, obesity, ophthalmic, CV, or metabolic diseases) unlikely to interfere with AZD6793 evaluation may be included.
(h) Long-term oxygen therapy >4.0 L/min. Subjects must maintain oxygen saturation ≥89% while using supplemental oxygen. Ambulatory subjects on long-term oxygen therapy who can attend outpatient visits may participate. As-needed oxygen use is allowed.
24. Concomitant use of any medication known to be associated with polymorphic ventricular tachycardia.
Prior/concurrent clinical trial participation
25. Known hypersensitivity to AZD6793 or any excipient.
26. Concurrent participation in another clinical trial involving an investigational treatment.
Other exclusion criteria
27. Investigator, sub-investigator, study nurse, site staff, AstraZeneca employee, or their first-degree relatives.
28. Inability to perform technically acceptable spirometry.
29. Randomization not permitted due to stratification closure.
30. Participation in the planning and/or conduct of this study (applies to AstraZeneca staff and/or site personnel).
31. Subjects deemed by the investigator unlikely to comply with study procedures, restrictions, or requirements.
32. Prior participation or randomization in this study or previous exposure to AZD6793.
33. Females only: Currently pregnant (positive pregnancy test) or breastfeeding. All women of childbearing potential must have negative pregnancy tests at Visit 1 (serum) and Visit 3 (urine).
Medical conditions
Clinically significant pulmonary diseases other than COPD (e.g., asthma [based on a current diagnosis per the Global Initiative for Asthma (GINA) or other acceptable criteria], active pulmonary infection, clinically significant bronchiectasis [when bronchiectasis is the primary diagnosis], pulmonary fibrosis, cystic fibrosis, obesity hypoventilation syndrome, lung cancer, α-1 antitrypsin deficiency, or primary ciliary dyskinesia). Subjects with a prior misdiagnosis of asthma or a history of asthma are not excluded.
Radiological evidence of a respiratory disease other than COPD that clearly accounts for the subject’s respiratory symptoms.
(a) Radiologic findings suggestive of lung nodules suspicious for lung cancer (per applicable guidance such as The American College of Radiology Lung CT Screening Reporting and Data System [ACR Lung-RADS v2022]; Christensen et al., 2024) that have not been appropriately followed up before Visit 3.
(b) Recent pulmonary imaging findings requiring immediate diagnostic investigation or follow-up. If repeat surveillance imaging has been performed and the abnormality is deemed low risk for malignancy, the subject may be eligible. This also applies to subjects participating in the optional HRCT substudy.
Any unstable disease deemed by the investigator that may involve, but is not limited to, cardiovascular (CV), gastrointestinal, hepatic, renal, neurologic, musculoskeletal, infectious, endocrine, metabolic, hematologic, psychiatric, major physiological, and/or cognitive disorders that:
(a) Affect subject safety during the study;
(b) Impact study findings or their interpretation; or
(c) Interfere with the subject’s ability to complete the study or comply with visit schedules and procedures.
Subjects with the following medical conditions:
(a) Significant left heart failure (i.e., New York Heart Association [NYHA] Class III or IV, or left ventricular ejection fraction <40% by echocardiogram or cardiac MRI [if available]).
(b) Unstable angina, acute coronary syndrome/myocardial infarction, percutaneous coronary intervention/coronary artery bypass grafting within 6 months prior to randomization, poorly controlled arrhythmias, cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary edema or fluid overload.
(c) Pulmonary hypertension that is idiopathic or secondary to connective tissue or thromboembolic disease.
Note: Subjects with pulmonary hypertension due to chronic lung disease may be eligible.
(d) History of conditions predisposing to infection (e.g., splenectomy, known primary or secondary immunodeficiency syndromes).
(e) History of ulcerative colitis, Crohn’s disease, or microscopic colitis confirmed by a gastroenterologist or histopathology.
(f) At baseline (Visit 3), >10% body surface area (BSA) depigmentation (e.g., vitiligo or other causes of depigmentation) as determined by the investigator. See Appendix H for regional BSA reference charts.
Abnormal laboratory results at screening:
(a) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 × upper limit of normal (ULN)
(b) Total bilirubin (TBL) >2 × ULN (unless due to Gilbert’s syndrome)
(c) Hemoglobin (Hb) <120 g/L (males); <110 g/L (females)
(d) White blood cell (WBC) count < lower limit of normal (LLN), absolute neutrophil count <2.5 × 10⁹/L, or platelet count <150 × 10⁹/L
(e) Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73 m² per CKD-EPI formula.
Note: Abnormal lab values may be retested once during screening (unless sample clotted, delayed, mishandled, or suspected lab error, in which case additional retesting is allowed).
Clinically significant abnormalities on a 12-lead ECG that, in the investigator’s judgment, increase subject risk. Atrial fibrillation is not exclusionary if heart rate is well-controlled and the subject has been on stable anticoagulation for ≥8 weeks.
Evidence of active and/or chronic liver disease. Subjects meeting any of the following will be excluded:
(a) Positive hepatitis C antibody unless hepatitis C virus (HCV) RNA is undetectable before randomization (for those previously treated for HCV, RNA assessment must be ≥12 weeks post-therapy).
(b) Positive hepatitis B surface antigen or history of hepatitis B infection. Subjects with a history of hepatitis B vaccination and no infection history may be included.
History or positive test for human immunodeficiency virus (HIV).
Clinically significant infection (viral, bacterial, or fungal) requiring systemic antimicrobial therapy >7 days within 4 weeks before Day 1 (Visit 3), including unexplained diarrhea, or clinically suspected infection at dosing. Subjects may be rescreened after resolution.
Prior lung volume reduction surgery.
History of bronchial thermoplasty or endobronchial valve placement within 6 months before Visit 1.
Use or requirement of long-term non-invasive positive pressure ventilation (NIPPV). Stable use of non-invasive ventilation for obstructive sleep apnea is allowed.
Current or past malignancy within 5 years before screening, except for:
(a) Low-risk prostate cancer under active surveillance;
(b) Completely treated cervical carcinoma in situ;
(c) Successfully treated ductal carcinoma in situ or localized medullary thyroid carcinoma with ≥1 year disease-free interval;
(d) Basal cell or superficial squamous cell skin cancers.
History of drug or alcohol abuse within 1 year prior to screening, or evidence suggesting such history.
Active or latent tuberculosis (TB) without completion of appropriate treatment or ongoing prophylaxis, as determined per local standard of care, potentially including history, physical exam, chest X-ray, or TB tests (e.g., PPD or QuantiFERON®).
Male or female subjects intending to become pregnant or donate sperm/eggs during the study or within 2 weeks after the last dose of IMP.
Prior/concomitant therapy
17. Current treatment with non-approved COPD background therapies (except nicotine vapor products or patches).
18. Major surgery within 8 weeks prior to screening or planned hospitalization for surgery during the study.
19. Treatment with broad-spectrum antibiotics (excluding chronic azithromycin) within 28 days prior to randomization (Visit 3).
20. Blood donation or blood product donation within 3 months before screening.
21. History of allogeneic bone marrow transplantation.
22. Initiation of a COPD rehabilitation program during the study. Subjects who have completed such a program may be enrolled immediately; maintenance participation is allowed.
23. Use of any prohibited concomitant medications as specified in the Clinical Study Protocol (CSP):
(a) Acute systemic (oral or injectable) corticosteroids within 28 days before Visit 1.
(b) Any other immunosuppressive therapy (e.g., methotrexate, cyclosporine, tacrolimus, azathioprine, or maintenance systemic corticosteroids) within 3 months before randomization. A ≤8-week course for acute/self-limited conditions is permitted but must end ≥4 weeks before Visit 1.
(c) Immunoglobulins, interferon-γ, or blood products within 28 days before Visit 1.
(d) Specific CYP-interacting drugs within 14 days before Visit 3 (see Table 8 for list).
(e) Metformin within 14 days before randomization.
(f) IMP within 4 months or 5 half-lives (whichever is longer) before randomization.
(g) Marketed biologics for respiratory disease within 4 months or 5 half-lives (whichever is longer) before consent.
Note: Subjects receiving stable marketed biologics ≥8 weeks for non-respiratory conditions (e.g., osteoporosis, migraine, pain, diabetes, obesity, ophthalmic, CV, or metabolic diseases) unlikely to interfere with AZD6793 evaluation may be included.
(h) Long-term oxygen therapy >4.0 L/min. Subjects must maintain oxygen saturation ≥89% while using supplemental oxygen. Ambulatory subjects on long-term oxygen therapy who can attend outpatient visits may participate. As-needed oxygen use is allowed.
24. Concomitant use of any medication known to be associated with polymorphic ventricular tachycardia.
Prior/concurrent clinical trial participation
25. Known hypersensitivity to AZD6793 or any excipient.
26. Concurrent participation in another clinical trial involving an investigational treatment.
Other exclusion criteria
27. Investigator, sub-investigator, study nurse, site staff, AstraZeneca employee, or their first-degree relatives.
28. Inability to perform technically acceptable spirometry.
29. Randomization not permitted due to stratification closure.
30. Participation in the planning and/or conduct of this study (applies to AstraZeneca staff and/or site personnel).
31. Subjects deemed by the investigator unlikely to comply with study procedures, restrictions, or requirements.
32. Prior participation or randomization in this study or previous exposure to AZD6793.
33. Females only: Currently pregnant (positive pregnancy test) or breastfeeding. All women of childbearing potential must have negative pregnancy tests at Visit 1 (serum) and Visit 3 (urine).
The Estimated Number of Participants
-
Taiwan
33 participants
-
Global
1160 participants
