Asthma (Diagnosis)
Conditions
Brief summary
A multicenter, randomized, double-blind, active-controlled, parallel-group Phase III clinical study comparing the efficacy and safety of Beclometasone Dipropionate and Formoterol Inhalation Aerosol versus FOSTER® in patients with asthma. The purpose of this study is to compare the efficacy and safety of the Beclomethasone Dipropionate and Formoterol Fumarate inhalation aerosol (manufactured by Lunan Better Pharmaceutical Co., Ltd.) with FOSTER® in the treatment of patients with asthma.
Interventions
Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks.
DRUGFOSTER®
Beclometasone Dipropionate and Formoterol Inhalation Aerosol was administered by oral inhalation at a dose of 2 actuations twice daily (morning and evening) for 4 consecutive weeks.
Sponsors
Lunan Better Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥18 and ≤75 years. 2. Clinically diagnosed with bronchial asthma for at least 3 months at screening (with traceable diagnostic evidence and medical records), and the diagnosis has been confirmed according to the Guidelines for the Prevention and Management of Bronchial Asthma, meeting the following criteria: a) Positive objective test for variable airflow limitation (i.e., meeting any one of the following): (i) Positive bronchodilator reversibility test (i.e., an increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL from pre-bronchodilator values after inhalation of a bronchodilator; or an increase in FEV₁ of ≥12% and an absolute increase of ≥200 mL from baseline after 4 weeks of anti-inflammatory therapy with an inhaled corticosteroid, excluding respiratory tract infections); or (ii) Positive bronchial provocation test: commonly using methacholine or histamine as the inhaled provocative agent, with a positive result defined as a ≥20% decrease in FEV₁ after inhalation, indicating airway hyperresponsiveness. (A positive result from any confirmed objective test for variable airflow limitation performed within 1 year prior to signing the ICF is acceptable; if not available, a positive bronchial provocation or bronchodilator reversibility test must be met at screening.) b) Pulmonary function test: FEV₁ ≥40% of predicted value. 3. Within at least 4 weeks prior to signing the ICF, the subject has been on a stable daily dose of an inhaled corticosteroid (ICS) with "as-needed" short-acting β₂-agonist (SABA) use but asthma is not well controlled (ACQ-5 ≥1.00), OR has been on a stable daily dose of an ICS plus a long-acting β₂-agonist (LABA) and asthma is well controlled (ACQ-5 \<1.00). 4. Subjects who use SABA or other reliever medications as needed before screening may be enrolled only if the investigator assesses that they can be switched to the unified rescue medication provided in this study. 5. Willing and able to comply with the protocol requirements and the investigator's instructions for pulmonary function tests, and, after training, able to correctly use the pressurized metered-dose inhaler (pMDI), peak flow meter, and complete the diary card records. 6. Willing to voluntarily participate in this study and sign the informed consent form after full informed consent.
Exclusion criteria
1. Have intermittent asthma or asthma that occurs only upon occasional exposure to allergens or chemical sensitizers. 2. Have a history of life-threatening asthma (e.g., brittle asthma, admission to the intensive care unit due to an acute asthma exacerbation) within 1 year prior to screening. 3. Have other respiratory system diseases, including but not limited to allergic bronchopulmonary aspergillosis (ABPA), active tuberculosis, pneumonia, pneumothorax, idiopathic pulmonary fibrosis, clinically significant atelectasis, chronic obstructive pulmonary disease (COPD), bronchopulmonary dysplasia, chronic bronchitis, or other significant pulmonary abnormalities other than asthma (such as cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency), and are considered by the investigator to be unsuitable for participation in this clinical study. 4. Have a respiratory tract infection of non-viral etiology, sinusitis, or otitis media within 4 weeks prior to screening. 5. Have a history of severe cardiovascular or cerebrovascular diseases, such as congestive heart failure of New York Heart Association (NYHA) class ≥II, unstable angina, coronary heart disease, myocardial infarction, stroke, etc., within 6 months prior to screening; have a prolonged QTc interval (QTc \>450 ms for males or \>470 ms for females, corrected using Fridericia's formula) or have ECG abnormalities that are assessed by the investigator as clinically significant and requiring pharmacological treatment; or have poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg after adequate treatment). 6. Have oral candidiasis identified at screening. 7. Have laboratory test results meeting any of the following criteria: Liver function: alanine aminotransferase (ALT) \>2×ULN and/or aspartate aminotransferase (AST) \>2×ULN, and total bilirubin (TBIL) \>2×ULN; Renal function: serum creatinine \>1.5×ULN; Fasting blood glucose \>10 mmol/L or glycated hemoglobin (HbA1c) ≥8.0%; Serum potassium \<3.5 mmol/L. 8. Have received biological targeted therapy (including anti-IgE monoclonal antibodies such as omalizumab, anti-IL-5 monoclonal antibodies such as mepolizumab, anti-IL-5 receptor monoclonal antibodies such as benralizumab, or anti-IL-4 receptor monoclonal antibodies such as dupilumab) within 5 half-lives prior to entry into the run-in period. 9. Have experienced an asthma exacerbation requiring systemic corticosteroid treatment or have required oral corticosteroid therapy within 4 weeks prior to screening, or have other diseases that require long-term oral or intravenous corticosteroid therapy. 10. Have used beta-blockers (including eye drops), quinidine, disopyramide, procainamide, phenothiazines, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or any other medications that may prolong the QTc interval and increase the risk of ventricular arrhythmias within 4 weeks prior to screening. 11. Have a history of drug abuse or alcohol abuse within 1 year prior to screening. 12. Are current smokers; have a smoking history of ≥10 pack-years (1 pack = 20 cigarettes); for those with a smoking history of \<10 pack-years, they must have stopped smoking for at least 6 months to be eligible for the study. 13. Have received treatment with any other investigational drug or device in another clinical trial within 3 months prior to screening. 14. Have a known intolerance to or contraindication to beta₂-agonists and/or inhaled corticosteroids, or are allergic to any component of the investigational products. 15. Are pregnant or breastfeeding; or are women of childbearing potential, or male subjects with partners of childbearing potential, who do not agree to use medically recognized effective contraceptive measures (such as an intrauterine device or condom) during the study and for 6 months after the last dose of the investigational product. 16. Meet any of the following conditions prior to randomization: 1. Run-in period compliance \<80% or \>120%; 2. Have an asthma exacerbation during the run-in period (including asthma-related serious adverse events, asthma worsening leading to hospitalization or emergency treatment, unscheduled visits resulting in changes in treatment, etc.); 3. Are considered by the investigator to be unsuitable for randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in forced expiratory volume in 1 second (FEV1) at Week 4 | Baseline to Week 4.(at the end of the 4-week treatment period) | Absolute change in FEV1 (in liters) from baseline to Week 4, measured by spirometry. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean daily diurnal variability of peak expiratory flow (PEF) | Baseline to Week 2; Baseline to Week 4. | Change from baseline in mean daily diurnal variability rate of peak expiratory flow (PEF) at the end of the 2-week and 4-week treatment periods.(Unit: %; Time points: Baseline to Week 2; Baseline to Week 4. |
| Change from baseline in trough (pre-dose) FEV1 at Week 2 | Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2 | Change from baseline in pre-dose forced expiratory volume in 1 second (FEV1) at Week 2, measured at the end of the 2-week treatment period prior to the next inhalation.Unit: L; Time Frame: Baseline to Week 2 (assessed immediately before the scheduled dose at the end of Week 2). |
| Change from baseline in forced vital capacity (FVC) at Weeks 2 and 4 (end of treatment) | Baseline to Week 2 and Week 4 (assessed at the end of each treatment period) | Liters (L) |
| Change from baseline in FEV1/FVC ratio at Weeks 2 and 4 (end of treatment) | Baseline to Week 2 and Week 4 (assessed at the end of each treatment period) | Percentage (%) |
| Change from baseline in maximum mid-expiratory flow (MMEF), also known as forced expiratory flow between 25% and 75% of vital capacity (FEF25%-75%), at Weeks 2 and 4 (end of treatment) | Baseline to Week 2 and Week 4 (assessed at the end of each treatment period) | Liters per second (L/s) |
| Change from baseline in Asthma Control Questionnaire (ACQ-5) score at Weeks 2 and 4 | Baseline to Week 2; Baseline to Week 4. | Change from baseline in the Asthma Control Questionnaire (ACQ-5) score at Week 2 and Week 4. The ACQ-5 is a 5-item questionnaire with a total score ranging from 0 to 6 (mean of items), where higher scores indicate poorer asthma control.(Unit: Score on a 0-6 scale). Change from baseline in ACQ-5 score at Week 2 (Time Frame: Baseline to Week 2);Change from baseline in ACQ-5 score at Week 4 (Time Frame: Baseline to Week 4). |
| Number of asthma exacerbations during the treatment period up to Weeks 2 and 4 | Baseline to Week 2, and Baseline to Week 4 (cumulative, assessed at the end of each treatment period) | An asthma exacerbation is defined as the occurrence of one or more of the following: (1) asthma-related serious adverse events (SAEs); (2) hospitalization or emergency department visit due to worsening of asthma; (3) need for a course of systemic corticosteroids (oral or injectable) for ≥3 days due to asthma worsening; (4) unscheduled visit leading to a change in therapy; or (5) withdrawal from the study due to lack of efficacy or requirement for a change in asthma medication. The cumulative number of exacerbations per patient will be recorded over the 2-week and 4-week treatment periods.Unit of Measure: Counts (number of events) |
| Proportion of patients with at least one asthma exacerbation during the treatment period up to Weeks 2 and 4 | Baseline to Week 2, and Baseline to Week 4 (cumulative, assessed at the end of each treatment period) | Unit of Measure: Percentage (%). An asthma exacerbation is defined as the occurrence of one or more of the following: (1) asthma-related serious adverse events (SAEs); (2) hospitalization or emergency department visit due to worsening of asthma; (3) need for a course of systemic corticosteroids (oral or injectable) for ≥3 days due to asthma worsening; (4) unscheduled visit leading to a change in therapy; or (5) withdrawal from the study due to lack of efficacy or requirement for a change in asthma medication. The proportion of patients experiencing at least one exacerbation will be calculated over the 2-week and 4-week treatment periods. |
| Rescue medication use during the treatment period | at Weeks 2 and 4 | — |
| Change from baseline in Asthma Quality of Life Questionnaire (AQLQ) score at Weeks 2 and 4 | Baseline to Week 2; Baseline to Week 4 | Change from baseline in the Asthma Quality of Life Questionnaire (AQLQ) score at Week 2 and Week 4. The AQLQ is a 35-item questionnaire with a total score ranging from 1 to 5 (mean of all items), where higher scores indicate better quality of life. |
| During the study period, monitor and record laboratory tests, ECGs, vital signs, and physical examinations; evaluate the type, incidence, severity, duration, and relationship to the investigational product of AEs and SAEs. | during the study period | — |
Countries
China
Contacts
CONTACTMei Ling Jin
CONTACTZhenju Song
Outcome results
None listed