The goal of this clinical trial is to evaluate whether budesonide/formoterol powder for inhalation (II) manufactured by Shanghai New Huanghe Pharmaceutical Co., Ltd. is non-inferior to the active comparator, Symbicort® Turbuhaler® (AstraZeneca), in the treatment of adult bronchial asthma, and to assess its safety profile in this population. The main questions it aims to answer are: Does the test product (budesonide/formoterol 160 μg/4.5 μg) show non-inferior efficacy compared to the reference product (Symbicort® Turbuhaler® 160 μg/4.5 μg) in improving lung function, as measured by the change from baseline in trough FEV1 after 42 days of treatment? What is the safety profile of the test product in adult patients with asthma? Researchers will compare participants receiving the test product plus placebo of the comparator to those receiving the active comparator plus placebo of the test product, to see if the test product is non-inferior to the reference product in terms of efficacy, with comparable safety. Participants will: Be randomized to receive either the test product (budesonide/formoterol 160 μg/4.5 μg, 2 inhalations twice daily) plus placebo of the comparator, or the active comparator (Symbicort® Turbuhaler® 160 μg/4.5 μg, 2 inhalations twice daily) plus placebo of the test product, for 6 weeks of treatment Perform daily morning and evening PEF measurements and record them, along with rescue medication use and any adverse events, in a diary card Attend regular clinic visits for pulmonary function tests, ACQ-5 and AQLQ questionnaires, safety assessments (vital signs, physical and oropharyngeal examinations, laboratory tests, and 12-lead ECG), and drug accountability
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
338
Budesonide/formoterol 160 μg/4.5 μg per inhalation, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.
Placebo matching the test product, containing inactive excipients only, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.
Active comparator: Symbicort® Turbuhaler® (budesonide/formoterol 160 μg/4.5 μg per inhalation), administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler. Manufactured by AstraZeneca.
Placebo matching the active comparator (Symbicort® Turbuhaler®), containing inactive excipients only, administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler.
Hefei First People's Hospital
Hefei, Anhui, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Change from baseline in trough FEV1 after 42 days of treatment
Trough FEV1 (forced expiratory volume in 1 second) measured before morning dosing at Day 43 (after 42 days of treatment). Change from baseline calculated as post-treatment value minus baseline value, where baseline is the pre-dose FEV1 measured on Day 1 before the first dose of study drug.
Time frame: Baseline (Day 1 pre-dose) to Day 43
FEV1 AUC0-12h on Day 1
Area under the curve for FEV1 from 0 to 12 hours after the first dose of study drug on Day 1.
Time frame: Day 1 (0 to 12 hours post-dose)
Change from baseline in trough FEV1 at Day 15 and Day 29
Trough FEV1 measured before morning dosing at Day 15 and Day 29. Change from baseline calculated as post-treatment value minus baseline value.
Time frame: Baseline (Day 1 pre-dose) to Day 15, Day 29
Change from baseline in FVC at Day 15, Day 29, and Day 43
FVC (forced vital capacity) measured pre-dose at each visit. Change from baseline calculated as post-treatment value minus baseline value.
Time frame: Baseline (Day 1 pre-dose) to Day 15, Day 29, Day 43
Change from baseline in morning PEF
Morning PEF (peak expiratory flow) measured pre-dose daily. Change from baseline is the mean morning PEF during each treatment week minus the mean morning PEF during the 7-day run-in period.
Time frame: Baseline (7-day run-in period) to weekly through Day 43
Change from baseline in PEF diurnal variability at Day 43
PEF diurnal variability calculated as 2 × (daily max PEF - daily min PEF) / (daily max PEF + daily min PEF) × 100%. Change from baseline is the mean of 7 days at Day 43 minus the mean of 7 days at baseline.
Time frame: Baseline (7-day run-in period) to Day 43
Change from baseline in ACQ-5 score at Day 15, Day 29, and Day 43
ACQ-5 (Asthma Control Questionnaire-5) score ranges from 0 to 6, with higher scores indicating poorer asthma control. Change from baseline is score at visit minus baseline score.
Time frame: Baseline (Day 0 pre-randomization) to Day 15, Day 29, Day 43
Change from baseline in AQLQ score at Day 15, Day 29, and Day 43
AQLQ (Asthma Quality of Life Questionnaire) score ranges from 1 to 7, with higher scores indicating better quality of life. Total score is the mean of all 32 items. Change from baseline is score at visit minus baseline score.
Time frame: Baseline (Day 0 pre-randomization) to Day 15, Day 29, Day 43
Percentage of rescue medication-free days during treatment
Percentage of days during the 6-week treatment period on which no rescue medication (salbutamol) was used.
Time frame: Day 1 through Day 43
Number of rescue medication uses during treatment
Total number of inhalations of rescue medication (salbutamol) used during the 6-week treatment period.
Time frame: Day 1 through Day 43
Asthma exacerbations during treatment
Number, severity, time to first occurrence, and annualized rate of asthma exacerbations (mild, moderate, and severe) during the treatment period.
Time frame: Day 1 through Day 43
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Gansu Provincial People's Hospital
Lanzhou, Gansu, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
Qingyuan, Guangdong, China
Zhanjiang Central People's Hospital
Zhanjiang, Guangdong, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
...and 18 more locations