Clinical Trials List
Protocol NumberD5982C00007
NCT Number(ClinicalTrials.gov Identfier)NCT04609878
Completed
2020-09-15 - 2025-12-31
Phase III
Recruiting12
A randomized, double-blind, double-dummy, parallel grouping, multi-center 24 to 52-week variable length trial designed to evaluate Budesonide, Glycopyrronium, and Formoterol Fumarate metered-dose inhalers (MDI) relative to Budesonide and Formoterol Fumarate MDI and Symbicort® pressure MDI, the efficacy and safety of adult and adolescent participants with poor asthma control (KALOS)
-
Trial Applicant
-
Sponsor
AstraZeneca
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Inn-Wen Chong 無
- 陳家閔 Division of Thoracic Medicine
- 鄭孟軒 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
- Ming-Ju Tsai 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Kuan-Yuan Chen Division of Thoracic Medicine
- Po-Hao Feng Division of Thoracic Medicine
- Wen-Te Liu Division of Thoracic Medicine
- 黃萬均 無
- Tzu-Tao Chen Division of Thoracic Medicine
- YEN-HAN TSENG 無
- JING-QUAN ZHENG Division of Thoracic Medicine
- Ching-Shan Luo Division of Thoracic Medicine
- YUN-KAI YEH 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
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chang-Wen Chen Division of Thoracic Medicine
- Po-Lan Su 無
- Chin-Wei Kuo Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Bing-Ru Wu Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
- Wen-Chien Cheng Division of Thoracic Medicine
- 廖偉志 Division of Thoracic Medicine
- Zhi-Yu Chen 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
- Chia-Cheng Tseng Division of Thoracic Medicine
- 蘇茂昌 Division of Thoracic Medicine
- 梁深怡 Division of Thoracic Medicine
- 張晃智 無
- 吳沼漧 Division of Thoracic Medicine
- CHIN-CHOU WANG 無
- 陳永哲 無
- 賴建豪 Division of Thoracic Medicine
- 黃國棟 Division of Thoracic Medicine
- 劉世豐 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Li Chung Division of Thoracic Medicine
- Kai-Ling Lee Division of Thoracic Medicine
- Shang-Fu Hsu Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Adults and adolescents with poor asthma control
Objectives
main target:
To evaluate the effect of BGF (Budesonide, Glycopyrronium, and Formoterol Fumarate) MDI compared with BFF (Budesonide and Formoterol Fumarate) MDI or Symbicort pMDI on lung function in subjects with poor asthma control.
Key secondary goals:
To evaluate the effect of BGF MDI compared with BFF MDI or Symbicort pMDI on lung function in subjects with poor asthma control.
Main summary analysis objectives:
To evaluate the effect of BGF MDI compared with BFF MDI or Symbicort pMDI on asthma attacks in subjects with poor asthma control.
Test Drug
BGF MDI
Active Ingredient
Budesonide, Glycopyrronium, Formoterol Fumarate
Dosage Form
inhalation
Dosage
160/14.4/4.8 ug, 160/7.2/4.8 ug
Endpoints
main indicators:
United States: The change in the area under the curve (AUC0-3) since the base period from 0 to 3 hours of forced expiratory volume in the first second (FEV1) at week 24
European Union (EU): Change in FEV1 from the base period with the lowest FEV1 before morning dosing in 24 weeks
Japan: Change in FEV1 from the base period before the morning dose within 12 to 24 weeks (applicable to Taiwan)
United States: The change in the area under the curve (AUC0-3) since the base period from 0 to 3 hours of forced expiratory volume in the first second (FEV1) at week 24
European Union (EU): Change in FEV1 from the base period with the lowest FEV1 before morning dosing in 24 weeks
Japan: Change in FEV1 from the base period before the morning dose within 12 to 24 weeks (applicable to Taiwan)
Inclution Criteria
Inclusion conditions
Subjects are eligible to be included in this trial only if they meet all of the following conditions:
age
1 Subjects must be at least 12 to 80 years old (inclusive) when they sign the consent form.
Note: For subjects aged 12 to <18 (the legal adult in Taiwan is 20 years old), if appropriate, the parent or legal guardian must provide a written consent form signed by the subject, and the subject must sign a written consent form. Copies of consent.
Subject type and disease characteristics
2 According to the Global Asthma Initiative (GINA) guidelines [GINA 2020], the subject had a history of asthma diagnosed by a physician at the first visit ≥ 1 year ago. For adolescent subjects (12 to <18 years of age), medical records within 1 year prior to the first visit must be provided to ensure that these subjects receive consistent treatment evaluation and follow-up.
3 Prior to the first visit, the subject had regularly used a stable ICS/LABA (inhaled steroid/long-acting ethylenedipose sympathetic nerve stimulant) course of treatment (including a stable ICS dose) at the allowable ICS dose. At least 4 weeks.
4 In the 12 months before the first return visit, there was at least one episode of asthma that required systemic corticosteroids (oral or intravenous) for at least 3 days, and related medical consultations, hospitalizations, or emergency room visits for asthma due to asthma (Within 3 days of corticosteroid use) medical history.
Note: This condition does not apply to subjects from 12 to <18 years old.
5 ACQ-7 total score ≥ 1.5 at the first, third and fifth visits (before random assignment).
6 Subjects aged ≥18 years old FEV1 before bronchodilator administration at the 1, 2, 3, 4, and 5 visits (before random assignment) <80% of the expected normal value, or 12 to <18 years old The subjects' FEV1 at the 1, 2, 3, 4, and 5 visits (before random assignment) was less than 90% of the expected normal value.
Note: If the subject did not suspend the use of asthma medication before the first visit, and did not meet the spirometer test conditions at the first visit, he should return to the office to repeat the spirometer test within two days. If the conditions are still not met after repeated spirometry tests, the subject must be judged as a screening failure.
7 Records show the reversibility of albuterol, defined as the second visit (or the third visit if repeated testing is required), the FEV1 of subjects ≥18 years of age increased by ≥ 12% after the administration of albuterol And ≥ 200 mL, or FEV1 in subjects 12 to <18 years of age increased ≥ 12% after administration of albuterol.
8 Willing and determined by the trial host to be able to adjust the current asthma therapy according to the requirements of the trial plan.
9 Able to demonstrate the correct MDI/pMDI operation method.
Note: It is not allowed to use the inhalation aid in the 4 weeks before the screening period and/or during the screening period and the randomized treatment period.
body weight
10 Body mass index <40 kg/m2.
gender
11 male and/or female
Reproduction
A urine pregnancy test result for female subjects 12 ≤ 60 years of age was negative.
13 Women who are fertile must agree to use contraceptives that are determined to be acceptable by the trial host.
Informed consent
14 Ability to sign the subject's consent form, which includes compliance with the requirements and restrictions listed in the subject's consent form and this trial plan.
Conditions confirmed at the 5th visit
15 During the screening period, we did not receive asthma medications other than BFF MDI BID and required albuterol, but did not include the permitted drugs defined in the plan, and systemic corticosteroids or ICS used to treat asthma attacks.
16 The 14-day compliance degree of the electronic log during the screening period is ≥ 70% (defined as the completion of the daily electronic log in any 10 morning and any 10 night, and any 10 morning and 10 night in the 14 days before random assignment The answer of BFF MDI during the second lead-in period is “Yes”).
17 No respiratory infections occurred within 4 weeks of random allocation, or no systemic corticosteroids and/or additional ICS treatment for asthma attacks occurred within 4 weeks of random allocation.
18 Before collecting selective genetic research specimens to support the Genome Project, provide signed and dated selective genetic research instructions and consent forms. (Not applicable in Taiwan)
Conditional inclusion conditions
Note: If the stratification of FEV1> 55% of the predicted normal value before bronchodilator administration is closed during the trial, inclusion criteria 19 will be substituted for inclusion criteria 6.
19 The FEV1 before bronchodilator administration at the 1, 2, 3, 4, and 5 visits (before random assignment) was less than 55% of the predicted normal value.
Subjects are eligible to be included in this trial only if they meet all of the following conditions:
age
1 Subjects must be at least 12 to 80 years old (inclusive) when they sign the consent form.
Note: For subjects aged 12 to <18 (the legal adult in Taiwan is 20 years old), if appropriate, the parent or legal guardian must provide a written consent form signed by the subject, and the subject must sign a written consent form. Copies of consent.
Subject type and disease characteristics
2 According to the Global Asthma Initiative (GINA) guidelines [GINA 2020], the subject had a history of asthma diagnosed by a physician at the first visit ≥ 1 year ago. For adolescent subjects (12 to <18 years of age), medical records within 1 year prior to the first visit must be provided to ensure that these subjects receive consistent treatment evaluation and follow-up.
3 Prior to the first visit, the subject had regularly used a stable ICS/LABA (inhaled steroid/long-acting ethylenedipose sympathetic nerve stimulant) course of treatment (including a stable ICS dose) at the allowable ICS dose. At least 4 weeks.
4 In the 12 months before the first return visit, there was at least one episode of asthma that required systemic corticosteroids (oral or intravenous) for at least 3 days, and related medical consultations, hospitalizations, or emergency room visits for asthma due to asthma (Within 3 days of corticosteroid use) medical history.
Note: This condition does not apply to subjects from 12 to <18 years old.
5 ACQ-7 total score ≥ 1.5 at the first, third and fifth visits (before random assignment).
6 Subjects aged ≥18 years old FEV1 before bronchodilator administration at the 1, 2, 3, 4, and 5 visits (before random assignment) <80% of the expected normal value, or 12 to <18 years old The subjects' FEV1 at the 1, 2, 3, 4, and 5 visits (before random assignment) was less than 90% of the expected normal value.
Note: If the subject did not suspend the use of asthma medication before the first visit, and did not meet the spirometer test conditions at the first visit, he should return to the office to repeat the spirometer test within two days. If the conditions are still not met after repeated spirometry tests, the subject must be judged as a screening failure.
7 Records show the reversibility of albuterol, defined as the second visit (or the third visit if repeated testing is required), the FEV1 of subjects ≥18 years of age increased by ≥ 12% after the administration of albuterol And ≥ 200 mL, or FEV1 in subjects 12 to <18 years of age increased ≥ 12% after administration of albuterol.
8 Willing and determined by the trial host to be able to adjust the current asthma therapy according to the requirements of the trial plan.
9 Able to demonstrate the correct MDI/pMDI operation method.
Note: It is not allowed to use the inhalation aid in the 4 weeks before the screening period and/or during the screening period and the randomized treatment period.
body weight
10 Body mass index <40 kg/m2.
gender
11 male and/or female
Reproduction
A urine pregnancy test result for female subjects 12 ≤ 60 years of age was negative.
13 Women who are fertile must agree to use contraceptives that are determined to be acceptable by the trial host.
Informed consent
14 Ability to sign the subject's consent form, which includes compliance with the requirements and restrictions listed in the subject's consent form and this trial plan.
Conditions confirmed at the 5th visit
15 During the screening period, we did not receive asthma medications other than BFF MDI BID and required albuterol, but did not include the permitted drugs defined in the plan, and systemic corticosteroids or ICS used to treat asthma attacks.
16 The 14-day compliance degree of the electronic log during the screening period is ≥ 70% (defined as the completion of the daily electronic log in any 10 morning and any 10 night, and any 10 morning and 10 night in the 14 days before random assignment The answer of BFF MDI during the second lead-in period is “Yes”).
17 No respiratory infections occurred within 4 weeks of random allocation, or no systemic corticosteroids and/or additional ICS treatment for asthma attacks occurred within 4 weeks of random allocation.
18 Before collecting selective genetic research specimens to support the Genome Project, provide signed and dated selective genetic research instructions and consent forms. (Not applicable in Taiwan)
Conditional inclusion conditions
Note: If the stratification of FEV1> 55% of the predicted normal value before bronchodilator administration is closed during the trial, inclusion criteria 19 will be substituted for inclusion criteria 6.
19 The FEV1 before bronchodilator administration at the 1, 2, 3, 4, and 5 visits (before random assignment) was less than 55% of the predicted normal value.
Exclusion Criteria
Exclude conditions
Subjects are not allowed to participate in the trial if they meet any of the following conditions:
Medical condition
1 Life-threatening asthma is defined as a major asthma event that requires intubation, accompanied by hypercapnia, respiratory arrest, hypoxic epilepsy, or asthma-related fainting events.
2 Within 4 weeks of the first visit, the systemic corticosteroid treatment for respiratory infections or asthma attacks was completed.
3 According to the opinion of the trial host, the subject is suitable for the treatment of asthma with biological therapy.
4 Had been hospitalized for asthma within 2 months before the first visit.
5 Previously suffering from or present evidence of clinically significant diseases, including but not limited to: cardiovascular, liver, kidney, hematology, nerve, endocrine, gastrointestinal or lung (for example: open tuberculosis, bronchiectasis, lung Eosinophilia syndrome, and chronic obstructive pulmonary disease). Significant is defined as the trial leader judged that participation in this trial will pose a risk to the safety of the subjects, or if the disease/condition worsens during the trial, it may affect the efficacy or safety analysis.
6 Known to have a history of drug or alcohol abuse within 12 months of the first visit
7 Within 3 months of the first visit, the trial leader determined that he had narrow-angle glaucoma that had not received appropriate treatment and/or vision changes that may be drug-related.
Note: All drugs that have been approved for intraocular pressure control are permitted, including topical ophthalmic non-selective beta blockers.
8 Clinically significant symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention judged by the trial leader.
Note: Subjects who have undergone transurethral prostatectomy or total prostatectomy within 6 months before the first visit will be excluded from the trial.
9 Before the first visit, there was an unresectable cancer that had not completely resolved and lasted for at least 5 years.
Note: Squamous cell and basal cell skin cancers do not constitute exclusionary conditions.
Previous/combined therapy
10 Use oral and intravenous corticosteroids (any dose) within 4 weeks of the first visit. The use of systemic corticosteroids for any other reason is prohibited during the trial period, but does not include the acute treatment of severe asthma attacks.
11 Have used long-acting corticosteroids for any reason within 12 months of the first visit.
12 LAMA was used as maintenance therapy within 12 months before the first visit, including alone or as part of inhaled concomitant therapy.
13 During the first 3 months of the first visit, he had used an oral beta-2 sympathetic nerve stimulant.
14 Received any commercially available (for example: omalizumab, mepolizumab, benralizumab, reslizumab) or experimental biological agents within 3 months or 5 half-lives (whichever is longer) during the first visit use.
15 Use a nebulizer or home nebulizer regularly to receive asthma medications.
Note: The short-term use of a nebulizer for asthma attacks in acute medical care is permitted, provided that it does not occur within 4 weeks of the first visit.
16 Any immunomodulators or immunosuppressive drugs have been used within 3 months or 5 half-lives (whichever is longer) and should not be used during the trial.
Note: The trial host may decide to allow local administration of immunosuppressive drugs at his discretion.
17 During screening and treatment, the banned drugs defined in the trial plan cannot be used.
18 Subjects received a personalized treatment action plan at home and were unwilling to contact the trial center before starting to use prednisolone (or an equivalent drug) to treat asthma attacks.
19 Any herbal product was used by inhalation or nebulizer within 4 weeks of the first visit, and he did not agree to stop using it during the trial.
Previous/simultaneous clinical trial experience
20 In the past 30 days or 5 half-life periods (whichever is longer), participated in another clinical trial using an experimental drug. Any other experimental products not specified in this test plan are forbidden to be used during the test period.
21 Subjects are known to be allergic to any component of B2 sympathetic nerve stimulants, corticosteroids, anticholinergic drugs, or MDI or pMDI.
Diagnostic evaluation
22 Subjects aged 18 to 80 repeated calculations using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula before the 5th visit or subjects 12 to <18 years old repeated calculations using the Schwartz formula before the 5th visit The creatinine clearance rate is ≤ 30 mL/min.
23 Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs or ECG, according to the opinion of the trial host, may put the subject at risk for participating in the trial.
Note: Subjects whose ECG QTcF interval (corrected for heart rate according to the Fridericia formula [QTcF]) ≥ 500 msec will be excluded. If the subject has high-grade atrioventricular block II or III, or has abnormal sinus node dysfunction with clinically significant arrest, and has not received pacemaker therapy, it will also be excluded.
Other exclusions
24 A current smoker, a past smoker with a smoking history> 10 pack-years, or a past smoker who quit smoking <6 months before the first visit (including all forms of cigarettes, e-cigarettes or other e-cigarettes) Device and marijuana).
25 Plan to be hospitalized during the trial period.
26 Participate in the planning and/or execution of this test (applicable to AstraZeneca employees and/or test center personnel).
27 Trial host, co-host, coordinator and their staff or close relatives.
28 If the subject is determined by the trial host to be unlikely to comply with the trial procedures, restrictions and requirements, the subject should not participate in the trial.
29 Has been or is currently randomly assigned to any budesonide and formoterol fumarate trial (PT009); budesonide, glycopyrronium, and formoterol fumarate trial (PT010); or glycopyrronium trial (PT001).
30 For females only-as determined by the trial host, are currently pregnant (confirmed by a positive pregnancy test result), are breastfeeding or plan to become pregnant during the trial, or are not using acceptable contraceptive measures.
Confirmation of inclusion conditions before random allocation
At the 5th visit, the following inclusion conditions for each subject must be confirmed before random assignment:
• Inclusion Criteria 5: ACQ-7 total score of the first, third and fifth visits ≥ 1.5.
• Inclusion condition 6: The pre-dose FEV1 from the 1st to 5th visits of subjects over 18 years old is <80% of the expected normal value, and the pre-dose FEV1 of subjects 12 to <18 years old is expected to be normal <90% of the value.
• Inclusion criteria 15: During the screening period, the introduction period BFF MDI BID and asthma drugs other than albuterol as needed were not accepted, but excluding the permitted drugs defined in the plan and systemic corticosteroids used to treat asthma attacks Or ICS.
• Inclusion condition 16: The 14-day compliance degree of the electronic log during the screening period is ≥ 70% (defined as the completion of the daily electronic log in any 10 morning and any 10 night, and there are any 10 morning and 10 days in the 14 days before random assignment. The answer to BFF MDI during the lead-in period was “yes” for 2 sprays that evening).
• Inclusion Criteria 17: No respiratory infections occurred within 4 weeks before random assignment, or no systemic corticosteroids and/or additional ICS were received for asthma attacks within 4 weeks of random assignment.
• Inclusion Criteria 19 (if applicable): FEV1 before bronchodilator administration at the 1, 2, 3, 4, and 5 visits (before random assignment) <55% of the predicted normal value.
Note: If the stratification of FEV1> 55% of the predicted normal value before bronchodilator administration is closed during the trial, inclusion criteria 19 will be substituted for inclusion criteria 6.
• Only applicable to continuous ECG monitoring sub-tests – there were no clinically significant findings in the baseline 24-hour continuous ECG monitoring.
Subjects are not allowed to participate in the trial if they meet any of the following conditions:
Medical condition
1 Life-threatening asthma is defined as a major asthma event that requires intubation, accompanied by hypercapnia, respiratory arrest, hypoxic epilepsy, or asthma-related fainting events.
2 Within 4 weeks of the first visit, the systemic corticosteroid treatment for respiratory infections or asthma attacks was completed.
3 According to the opinion of the trial host, the subject is suitable for the treatment of asthma with biological therapy.
4 Had been hospitalized for asthma within 2 months before the first visit.
5 Previously suffering from or present evidence of clinically significant diseases, including but not limited to: cardiovascular, liver, kidney, hematology, nerve, endocrine, gastrointestinal or lung (for example: open tuberculosis, bronchiectasis, lung Eosinophilia syndrome, and chronic obstructive pulmonary disease). Significant is defined as the trial leader judged that participation in this trial will pose a risk to the safety of the subjects, or if the disease/condition worsens during the trial, it may affect the efficacy or safety analysis.
6 Known to have a history of drug or alcohol abuse within 12 months of the first visit
7 Within 3 months of the first visit, the trial leader determined that he had narrow-angle glaucoma that had not received appropriate treatment and/or vision changes that may be drug-related.
Note: All drugs that have been approved for intraocular pressure control are permitted, including topical ophthalmic non-selective beta blockers.
8 Clinically significant symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention judged by the trial leader.
Note: Subjects who have undergone transurethral prostatectomy or total prostatectomy within 6 months before the first visit will be excluded from the trial.
9 Before the first visit, there was an unresectable cancer that had not completely resolved and lasted for at least 5 years.
Note: Squamous cell and basal cell skin cancers do not constitute exclusionary conditions.
Previous/combined therapy
10 Use oral and intravenous corticosteroids (any dose) within 4 weeks of the first visit. The use of systemic corticosteroids for any other reason is prohibited during the trial period, but does not include the acute treatment of severe asthma attacks.
11 Have used long-acting corticosteroids for any reason within 12 months of the first visit.
12 LAMA was used as maintenance therapy within 12 months before the first visit, including alone or as part of inhaled concomitant therapy.
13 During the first 3 months of the first visit, he had used an oral beta-2 sympathetic nerve stimulant.
14 Received any commercially available (for example: omalizumab, mepolizumab, benralizumab, reslizumab) or experimental biological agents within 3 months or 5 half-lives (whichever is longer) during the first visit use.
15 Use a nebulizer or home nebulizer regularly to receive asthma medications.
Note: The short-term use of a nebulizer for asthma attacks in acute medical care is permitted, provided that it does not occur within 4 weeks of the first visit.
16 Any immunomodulators or immunosuppressive drugs have been used within 3 months or 5 half-lives (whichever is longer) and should not be used during the trial.
Note: The trial host may decide to allow local administration of immunosuppressive drugs at his discretion.
17 During screening and treatment, the banned drugs defined in the trial plan cannot be used.
18 Subjects received a personalized treatment action plan at home and were unwilling to contact the trial center before starting to use prednisolone (or an equivalent drug) to treat asthma attacks.
19 Any herbal product was used by inhalation or nebulizer within 4 weeks of the first visit, and he did not agree to stop using it during the trial.
Previous/simultaneous clinical trial experience
20 In the past 30 days or 5 half-life periods (whichever is longer), participated in another clinical trial using an experimental drug. Any other experimental products not specified in this test plan are forbidden to be used during the test period.
21 Subjects are known to be allergic to any component of B2 sympathetic nerve stimulants, corticosteroids, anticholinergic drugs, or MDI or pMDI.
Diagnostic evaluation
22 Subjects aged 18 to 80 repeated calculations using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula before the 5th visit or subjects 12 to <18 years old repeated calculations using the Schwartz formula before the 5th visit The creatinine clearance rate is ≤ 30 mL/min.
23 Any clinically significant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs or ECG, according to the opinion of the trial host, may put the subject at risk for participating in the trial.
Note: Subjects whose ECG QTcF interval (corrected for heart rate according to the Fridericia formula [QTcF]) ≥ 500 msec will be excluded. If the subject has high-grade atrioventricular block II or III, or has abnormal sinus node dysfunction with clinically significant arrest, and has not received pacemaker therapy, it will also be excluded.
Other exclusions
24 A current smoker, a past smoker with a smoking history> 10 pack-years, or a past smoker who quit smoking <6 months before the first visit (including all forms of cigarettes, e-cigarettes or other e-cigarettes) Device and marijuana).
25 Plan to be hospitalized during the trial period.
26 Participate in the planning and/or execution of this test (applicable to AstraZeneca employees and/or test center personnel).
27 Trial host, co-host, coordinator and their staff or close relatives.
28 If the subject is determined by the trial host to be unlikely to comply with the trial procedures, restrictions and requirements, the subject should not participate in the trial.
29 Has been or is currently randomly assigned to any budesonide and formoterol fumarate trial (PT009); budesonide, glycopyrronium, and formoterol fumarate trial (PT010); or glycopyrronium trial (PT001).
30 For females only-as determined by the trial host, are currently pregnant (confirmed by a positive pregnancy test result), are breastfeeding or plan to become pregnant during the trial, or are not using acceptable contraceptive measures.
Confirmation of inclusion conditions before random allocation
At the 5th visit, the following inclusion conditions for each subject must be confirmed before random assignment:
• Inclusion Criteria 5: ACQ-7 total score of the first, third and fifth visits ≥ 1.5.
• Inclusion condition 6: The pre-dose FEV1 from the 1st to 5th visits of subjects over 18 years old is <80% of the expected normal value, and the pre-dose FEV1 of subjects 12 to <18 years old is expected to be normal <90% of the value.
• Inclusion criteria 15: During the screening period, the introduction period BFF MDI BID and asthma drugs other than albuterol as needed were not accepted, but excluding the permitted drugs defined in the plan and systemic corticosteroids used to treat asthma attacks Or ICS.
• Inclusion condition 16: The 14-day compliance degree of the electronic log during the screening period is ≥ 70% (defined as the completion of the daily electronic log in any 10 morning and any 10 night, and there are any 10 morning and 10 days in the 14 days before random assignment. The answer to BFF MDI during the lead-in period was “yes” for 2 sprays that evening).
• Inclusion Criteria 17: No respiratory infections occurred within 4 weeks before random assignment, or no systemic corticosteroids and/or additional ICS were received for asthma attacks within 4 weeks of random assignment.
• Inclusion Criteria 19 (if applicable): FEV1 before bronchodilator administration at the 1, 2, 3, 4, and 5 visits (before random assignment) <55% of the predicted normal value.
Note: If the stratification of FEV1> 55% of the predicted normal value before bronchodilator administration is closed during the trial, inclusion criteria 19 will be substituted for inclusion criteria 6.
• Only applicable to continuous ECG monitoring sub-tests – there were no clinically significant findings in the baseline 24-hour continuous ECG monitoring.
The Estimated Number of Participants
-
Taiwan
30 participants
-
Global
2200 participants
