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Clinical Trials List

Protocol NumberD7860C00006
NCT Number(ClinicalTrials.gov Identfier)NCT07082738
Active

2025-06-01 - 2028-12-31

Recruiting10

A multicenter, parallel-group, phase 2b, randomized, double-blind, placebo-controlled, 4-group, 24-week trial evaluating the efficacy and safety of AZD6793 tablets in adult subjects with moderate to very severe chronic obstructive pulmonary disease (PRESTO).

  • Trial Applicant

  • Sponsor

    AstraZeneca Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/28

Investigators and Locations

Principal Investigator Pin-Kuei Fu Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 何明霖 Division of Thoracic Medicine
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭舒帆 Division of Thoracic Medicine
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jung-Yien Chien Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃國棟 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Chao Lin Division of Thoracic Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林慶雄 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chau-Chyun Sheu Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jer-Hwa Chang Division of Thoracic Medicine
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張博瑞
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Evaluate the effect of AZD6793 compared to placebo on the rate of exacerbations in moderate or severe COPD.

Objectives

The aim of this trial was to evaluate the rate of exacerbation of AZD6793 compared to placebo in subjects with moderate to very severe chronic obstructive pulmonary disease.

Test Drug

AZD6793

Active Ingredient

AZD6793

Dosage Form

Tablets

Dosage

5 mg, 15 mg, 45 mg

Endpoints

Evaluate the effect of AZD6793 compared to placebo on the rate of exacerbations in moderate or severe COPD.

Inclution Criteria

Only participants meeting all of the following criteria are eligible to participate in this trial:

Age
1. Participants must be ≥ 40 years old at the time of signing the participant consent form.

Participant Type and Disease Characteristics
2. Data showing a preliminary diagnosis of moderate to very severe chronic obstructive pulmonary disease (COPD) at least 12 months prior to enrollment.

3. At the first follow-up visit, the forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) ratio is < 0.7 before BD administration, and at the second follow-up visit, the FEV1/FVC ratio is < 0.7 before and after BD administration, and the post-BD FEV1 is ≥ 25% to < 80% of the predicted normal value. If the pre-BD FEV1/FVC ratio is ≥ 0.7, post-BD spirometry should not be performed.

4. Data showing ≥ 2 moderate or ≥ 1 severe COPD exacerbation within 12 months prior to screening (first follow-up visit). Subjects with data showing one moderate COPD exacerbation within 12 months prior to screening (but limited to 20% of the total sample) are also eligible. At least one eligible COPD exacerbation must have been recorded during the required stable maintenance therapy course. Acceptable documentation includes:

(a) In-clinic follow-up or consultation records (primary or specialist healthcare provider) or emergency room/hospital records providing evidence of a COPD exacerbation event

(b) Data showing a prescription for at least 3 days of systemic corticosteroids (or a single injection of a long-acting formulation) and/or antibiotics for the treatment of a COPD exacerbation. For subjects with a self-management plan, records of receiving prescription medications to replace the above treatments will be considered eligible.

(c) A discharge summary from a hospital, emergency room, emergency care facility, or other equivalent medical facility showing that the subject was hospitalized due to COPD exacerbation or received systemic corticosteroids or antibiotics, or

(d) Evidence from a pharmacy for a prescription for systemic corticosteroids (over 3 days or a single injection of a long-acting formulation) and/or antibiotics.

5. Data showing a stable course of ≥ 3 months of triple maintenance inhaled therapy or dual maintenance inhaled therapy (if triple maintenance inhaled therapy is not suitable) prior to screening (first follow-up visit). Triple maintenance inhaled therapy may consist of an appropriate combination of inhaled corticosteroids (ICS) + long-acting β2 agonists (LABA) + long-acting muscarinic antagonists (LAMA). When the attending physician deems a subject unsuitable for triple therapy or ICS (e.g., eosinophil count ≤ 100 cells/mL at two different time points, or based on prior or perceived risk of a significant adverse event (AE) due to inhaled ICS therapy, such as a previous pneumonia or severe oral candidiasis), dual therapy may consist of ICS + LABA, ICS + LAMA, or inhaled LABA + LAMA.

 Both triple and dual maintenance therapies may be administered via a single inhaler or a fixed-dose combination inhaler. Written evidence of these prescriptions and/or the medications must be provided. The subject's oral history is not considered sufficient evidence.

 Individual components may be changed or switched between devices as long as the subject continues to receive the same class of therapy at an equivalent dose.

- Use of short-acting muscarinic antagonists (SAMA) at routinely scheduled intervals (at least 3 times per day) is considered equivalent to LAMA.

* If the subject is receiving oral COPD maintenance therapy (e.g., azithromycin, roflumilast), this therapy must also be maintained stably for at least 3 months prior to screening (first follow-up visit) (see Table 6).

6. COPD assessment test (CAT) score ≥ 10 at the first follow-up visit.

7. Current or former smokers with a smoking history of ≥ 10 pack-years.

Pack-years are calculated as average number of cigarettes per day × number of years / 20. For example, one pack-year = 20 cigarettes per day for 1 year, or 10 cigarettes per day for 2 years.

(a) Former smokers will be defined as current non-smokers who have quit smoking ≥ 6 months prior to screening and intend to quit permanently.

(b) Use of e-cigarettes (devices that vaporize liquids [e.g., nicotine, tetrahydrocannabinol]) and heated tobacco products will not be counted towards the pack-year eligibility criteria.

8. Subjects who are clinically stable and have no COPD exacerbation for 4 weeks prior to the first follow-up visit and remain exacerbation-free at the third follow-up visit (randomized).

9. Subjects who are willing to continue their current COPD therapy throughout the trial (except for adverse events requiring a change in therapy).

10. Women of childbearing potential (WOCBP) with negative pregnancy tests at both the first and third follow-up visits.

11. Subjects with at least 70% adherence to COPD maintenance therapy within 2 weeks prior to the third follow-up visit.

12. Patient-reported outcome (PRO) compliance must be at least 70% during the last 14 days of the screening period. This means completing at least 10 nightly electronic logs during the 14 days prior to the third follow-up visit (randomized return).

13. Subjects must be able to read, write, and use electronic devices.

Weight
14. Body mass index (BMI) must be between 18 and 44.9 kg/m² (inclusive).

Sexual Behavior and Contraception/Barrier Method Requirements
15. Women not of childbearing potential (WNOCBP) are defined as women who have undergone permanent sterilization (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or are postmenopausal. The following age-specific requirements must be met:

* Women under 50 years of age are considered postmenopausal if they have not menstruated for 12 months or longer after stopping exogenous hormone therapy and their follicle-stimulating hormone (FSH) levels are within the postmenopausal range.

* Women 50 years of age or older are considered postmenopausal if they have not menstruated for 12 months or longer after stopping all exogenous hormone therapy.

Contraceptive methods used by fertile participants should comply with local regulations regarding contraceptive methods for clinical trial participants.

* All WOCBP participants who have sexual intercourse with an unsterilized male partner must consent to the use of a highly effective method of contraception (see list below).

* WOCBP participants must consistently use an approved method of contraception for at least 3 months prior to their 3rd follow-up visit and continue using it throughout the trial and for 2 weeks after the last dose of the investigational medicinal product (IMP). Unsterile male partners of WOCBP participants must use condoms from screening, throughout the trial, and for two weeks after the last IMP dose.

**All unsterile male participants who have sexual intercourse with WOCBP participants must agree to use condoms from randomization, throughout the trial, and for two weeks after the last IMP dose.** WOCBP partners must agree to use a highly effective method of contraception and must have been consistently using an approved method of contraception for at least 3 months prior to the 3rd follow-up visit, and continue using it throughout the trial and for two weeks after the last IMP dose (see Appendix J for acceptable methods of contraception). Highly effective contraceptive methods for WOCBP participants include:

* Non-hormonal contraception:
* Complete abstinence, provided this is the participant's usual lifestyle (defined as avoiding sexual intercourse with the opposite sex throughout the treatment-related risk period of the trial)
* Partner has undergone vasectomy (confirmed absence of sperm in semen)
* Bilateral tubal ligation (Note: failure rate > 1%)
* Intrauterine device (containing copper)

The following contraceptive methods are unacceptable to WOCBP participants:
* Periodic abstinence (natural rhythm method, symptom-basal body temperature method, post-ovulation contraception)
* Withdrawal method (coitus interruptus)
* Spermicidal use only
* Lactational amenorrhea method
* Female condoms

Hormonal contraception:
* Levonorgestrel intrauterine system
* Medroxyprogesterone injection
* Combined oral or transdermal contraceptive (ethinylestradiol plus progestin) o Intravaginal contraceptive devices (e.g., ethinyl estradiol and etoposide)

o Intrauterine hormone-releasing systems
Informed Consent

16. Able to provide a signed participant consent form (as described in Appendix A) that includes compliance with the Informed Consent Form (ICF) and the requirements and limitations listed in this trial protocol.

17. Provide a signed and dated written ICF before performing any necessary trial-specific procedures, specimen collection, or analysis.

18. Provide a signed and dated Selective Genome Project Study Information and Informed Consent Form (see Appendix D 2) before collecting specimens for the Selective Genome Project study to support the Genome Project. Not applicable to participants in China.

19. Provide a signed and dated written High-resolution computed tomography (HRCT) sub-trial consent form (see Appendix G 1) before performing sub-trial procedures (if applicable).

20. Before proceeding with the sub-trial procedure (if applicable), provide a signed and dated written consent form for the subject experience interview sub-trial (see Appendix G 6).

Exclusion Criteria

Subjects must meet any of the following criteria to participate in the trial: Medical Condition
1. Clinically significant lung disease other than COPD (e.g., asthma [current diagnosis based on the Global Initiative for Asthma (GINA) or other acceptable criteria], active lung infection, clinically significant bronchiectasis (when bronchiectasis is the primary diagnosis), pulmonary fibrosis, cystic fibrosis, obesity-related hypoventilation syndrome, lung cancer, alpha-1 antitrypsin deficiency, or primary ciliary dyskinesia). Those previously misdiagnosed with asthma or with a history of asthma are not excluded.

2. Radiological findings indicating a respiratory disease other than COPD that significantly causes respiratory symptoms in the subject.

(a) A pulmonary nodule radiographic finding suspected of being lung cancer, based on applicable guidelines (e.g., the American College of Radiology Lung CT Screening Reporting and Data System, ACR Lung-RADS v2022, [Christensen et al, 2024]), and not properly followed up before the third follow-up visit.

(b) A recent pulmonary imaging finding requiring immediate diagnostic investigation or follow-up. Subjects may be eligible if initial repeat monitoring angiography has been performed and the abnormality is considered low-risk for malignancy. This also applies to subjects participating in a selective HRCT scan subtrial.

3. Any disease deemed unstable by the trial administrator and potentially leading to the following, including but not limited to cardiovascular (CV), gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, major physical, and/or cognitive impairment:

(a) affecting the subject's safety throughout the trial.

(b) affecting the trial's findings or interpretation. (c) Impairment in completing the entire trial period and/or adhering to the trial return schedule and procedures.

4. Subjects with the following medical conditions:

(a) Significant left ventricular failure (i.e., New York Heart Association functional class III or IV, or echocardiography or magnetic resonance imaging (MRI) showing a left ventricular ejection fraction < 40% [if such a result is present]).

(b) Unstable angina, acute coronary syndrome/acute myocardial infarction, or coronary intervention via percutaneous coronary intervention/coronary artery bypass grafting within 6 months prior to randomization, poorly controlled arrhythmia, cardiomyopathy, clinically significant aortic stenosis, or signs of pulmonary edema or fluid overload.

(c) Pulmonary hypertension, possibly idiopathic or caused by connective tissue or thromboembolic disease.

Note: Subjects with pulmonary hypertension due to chronic lung disease are eligible.

(d) History of other underlying conditions that could predispose the subject to infection (e.g., splenectomy, known primary or secondary immunodeficiency syndrome).

(e) History of ulcerative colitis, Crohn's disease, or microscopic colitis confirmed by a gastroenterologist or histopathologist.

(f) At the baseline period (3rd follow-up visit), the trial administrator determined that there was >10% loss of pigmentation in the body surface area (BSA) (e.g., leukoplakia or other causes of pigmentation loss). See Appendix H for regional BSA percentage charts.

5. The following abnormal laboratory test results were observed during screening:

(a) Alanine aminotransferase/transaminase (ALT) or aspartate aminotransferase/transaminase (AST) > 2 × Upper limit of normal (ULN)

(b) Total bilirubin (TBL) > 2 × ULN (unless caused by Gilbert's disease)

(c) Haemoglobin (Hb) < 120 g/L (male); Hb < 110 g/L (female)

(d) White blood cell (WBC) < Lower limit of normal (LLN), neutrophil count < 2.5 × 10⁹/L, platelet count < 150 × 10⁹/L 10⁹/L

(e) Estimated glomerular filtration rate calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula < 45 mL/min/1.73 m².

Note: Abnormal laboratory values ​​may be repeated once during screening (except where the specimen has coagulated, processing is delayed, other procedural errors occur, or a laboratory error is suspected, in which case additional retesting is permitted).

6.12-lead electrocardiogram (ECG) with any clinically significant abnormality that, in the assessment of the trial administrator, would increase the risk to the subject. Atrial fibrillation is not ruled out if heart rate is well controlled and the subject has received stable anticoagulant therapy for at least 8 weeks.

7. Subjects with evidence of active liver disease and/or chronic liver disease. Subjects will be excluded from the trial if they meet any of the following criteria:

(a) Subjects with a positive hepatitis C antibody test result, unless the hepatitis C virus (HCV) ribonucleic acid (RNA) concentration could not be measured prior to randomization. Please note that if a subject has received HCV treatment, RNA concentration must be assessed more than 12 weeks after treatment completion.

(b) Hepatitis B surface antigen positive or a history of hepatitis B positivity. Subjects with a history of hepatitis B vaccination but no history of hepatitis B may be included.

8. Subjects with a history of human immunodeficiency virus (HIV) infection or a positive HIV test result.

9. A history of clinically significant infection (viral, bacterial, or fungal; defined as requiring systemic antibiotics, antiviral, or antifungal medication for >7 days) within 4 weeks prior to Day 1 (3rd follow-up visit) (including unexplained diarrhea), or a clinically suspected infection at the time of administration. Subjects may be rescreened after infection resolution.

10. A history of lung volume reduction surgery.

11. A history of bronchial thermoplasty or bronchial valve implantation within 6 months prior to the first follow-up visit.

12. Use of or long-term use of any nasal intermittent positive pressure ventilation device (NIPPV). Stable use of non-invasive ventilation for obstructive sleep apnea is permitted.

13. History of malignancy within the past 5 years, either currently or prior to screening follow-up, except for the following:

(a) Low-risk prostate cancer under active surveillance

(b) Completely cured cervical carcinoma in situ

(c) Successfully treated ductal carcinoma in situ or medullary thyroid carcinoma with at least one year of no recurrence

(d) Subjects with basal cell or superficial squamous cell carcinoma of the skin.

14. History of drug or alcohol abuse within the past year, or a reasonable suspicion that the subject has a history of drug or alcohol abuse.

15. Subjects with evidence of active tuberculosis (TB) (regardless of treatment status) or latent TB as determined by the trial administrator, who have not completed an appropriate course of treatment or received appropriate ongoing prophylactic treatment. Assessment will be conducted according to local Standard of Care (SoC) as determined by local guidelines, and may include medical history and physical examination, chest X-ray, or TB testing (e.g., purified protein derivatives or QuantiFERON® test).

16. Male or female participants who wish to become pregnant during the trial and within 2 weeks after the last dose of IMP, or who wish to donate sperm or eggs.

Previous/Concomitant Therapies

17. Participants are currently receiving COPD background treatment (excluding nicotine vapor products or patches) that has not been approved by the competent authority in the trial country.

18. Participants have undergone major surgery within 8 weeks prior to screening, or plan to undergo inpatient surgery or hospitalization during the trial.

19. Participants have received broad-spectrum antibiotics (excluding long-term azithromycin) within 28 days (4 weeks) prior to randomization (3rd follow-up visit).

20. Participants have donated blood or blood products within 3 months prior to screening.

21. Participants have a history of allogeneic bone marrow transplantation.

22. Participants will begin a COPD rehabilitation program at any time during the trial. Recruitment may commence immediately upon completion of the COPD rehabilitation program. Continuation of the maintenance program is permitted.

23. Currently receiving any contraindicated medications, such as those specified in the Clinical Study Protocol (CSP):

(a) Received an acute systemic (oral or injectable) corticosteroid within 28 days (4 weeks) prior to the first follow-up visit.

(b) Received any other immunosuppressive therapy (including methotrexate, cyclosporine, tacrolimus, azathioprine, or maintenance systemic steroid therapy) within 3 months prior to randomization. Systemic corticosteroid therapy for up to 8 weeks is permitted for the treatment of acute or self-limiting symptoms, but must be completed 4 weeks prior to the first follow-up visit.

(c) Used immunoglobulin, interferon-gamma, or blood products within 28 days (4 weeks) prior to the first follow-up visit.

(d) Use of specific cytochrome P450 (CYP) interacting drugs 14 days (2 weeks) prior to the 3rd follow-up visit. See Table 8 for a list of such drugs.

(e) Use of metformin 14 days (2 weeks) prior to randomization (3rd follow-up visit).

(f) Received IMP within 4 months or 5 half-lives (whichever is longer) prior to randomization.

(g) Use of a commercially available biologic for respiratory illness within 4 months or 5 half-lives (whichever is longer) prior to the date of informed consent.

Note: Subjects who have received stable therapy for non-respiratory illness for at least 8 weeks prior to randomization and plan to continue receiving a commercially available biologic throughout the trial, and whose biologic is unlikely to interfere with the assessment of the safety and/or efficacy of AZD6793 (e.g., for the treatment of osteoporosis, migraine, pain, diabetes, obesity, eye, CV, or metabolic diseases), are eligible to participate in the trial. (h) Long-term oxygen therapy > 4.0 L/min. Subjects must show an oxygen saturation ≥ 89% while receiving supplemental oxygen. Subjects receiving long-term oxygen therapy must be able to walk and attend outpatient follow-ups to be eligible for the trial. Note: Oxygen may be used as needed.

24. Any concomitant medications known to be associated with polymorphic ventricular tachycardia.

Previous/concurrent clinical trial experience

25. Subjects known to be allergic to AZD6793 or any of the drug excipients.

26. Concurrent participation in another clinical trial involving the investigational treatment.

Other exclusion criteria

27. Subjects who are the trial principal investigator, co-principal investigator, trial nurse, or employees of the trial center or AstraZeneca, or are a first-degree relative of the aforementioned individuals.

28. Inability to perform technically acceptable spirometry.

29. Randomization is not permitted due to stratification termination.

30. Participation in the planning and/or execution of this trial (applicable to AstraZeneca employees and/or trial center personnel).

31. If the trial administrator determines that a subject is unlikely to comply with the trial procedures, restrictions, and requirements, that subject should not participate in the trial.

32. Previously participated in or randomized to this trial or previously treated with AZD6793.

33. Female only – currently pregnant (confirmed pregnancy test result) or breastfeeding. All WOCBP subjects must have negative pregnancy tests at the first follow-up visit (serum) and the third follow-up visit (urine).

The Estimated Number of Participants

  • Taiwan

    33 participants

  • Global

    1160 participants

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