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CompletedNCT07790159BF-ASTHMAUpdated Aug 27, 2026

Budesonide/Formoterol Inhalation Powder in Adults With Asthma

A Phase 3 interventional study of Budesonide and Formoterol Fumarate and Placebo of Budesonide and Formoterol Fumarate in Asthma, sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd.. Completed at 28 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
338
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Asthma

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Keywords

  • Asthma
  • Budesonide, Formoterol Fumarate Drug Combination
  • Anti-Asthmatic Agents
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who can understand and comply with the study procedures and methods, are willing to strictly follow the protocol to complete the study, and have signed the written informed consent form.
  2. Aged 18 to 75 years (inclusive), male or female.
  3. Diagnosed with bronchial asthma according to the Chinese Guidelines for the Prevention and Management of Bronchial Asthma (2020 edition), with documented medical records, and currently inadequately controlled asthma (ACQ-5 score ≥ 1.0).
  4. Non-smokers, or have quit smoking for at least 1 year (including cigarettes, cigars, pipe tobacco), with a smoking history of ≤ 30 pack-years [smoking index (pack-years) = daily smoking amount (packs) × smoking duration (years), 1 pack = 20 cigarettes].

  5. Positive result from any objective test for variable airflow limitation, either:

    1. Positive evidence from tests performed within 1 year prior to screening, including bronchodilator reversibility test, bronchial provocation test, or mean daily PEF diurnal variability > 10% or weekly PEF variability > 20%; or
    2. If no positive test result within 1 year prior to screening, positive bronchodilator reversibility test during screening (FEV1 increase > 12% and absolute increase > 200 mL, 15-30 minutes after inhalation of 400 μg salbutamol), or positive bronchial provocation test.
  6. Pre-bronchodilator FEV1 between 45% and 85% of predicted normal value at screening.
  7. Patients who agree to have no plans for fertility, sperm or egg donation, and voluntarily use effective physical contraception (including their partners) during the study and for 3 months after the last dose.

Exclusion criteria

Exclusion Criteria:

  1. Life-threatening asthma, defined as asthma attack requiring intubation within 1 year prior to screening or during run-in, and/or history of hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncope.
  2. Hospitalization due to asthma within 2 months prior to screening.
  3. Acute upper or lower respiratory tract bacterial infection requiring systemic antibiotic treatment within 4 weeks prior to screening, which led to a change in asthma treatment or, in the investigator's judgment, would alter the subject's asthma status or affect participation.
  4. Known hypersensitivity to any sympathomimetic drug (e.g., formoterol or salbutamol), any corticosteroid therapy, or lactose (excipient of the study drug).
  5. Concurrent respiratory diseases other than asthma, including but not limited to active pneumonia, idiopathic pulmonary fibrosis, clinically significant atelectasis, active pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, etc., which in the investigator's judgment may place the subject at undue risk or affect the assessment of study results.
  6. History of malignancy of any organ system within the past 5 years (except localized basal cell carcinoma of the skin or carcinoma in situ of the cervix), treated or untreated, with or without evidence of local recurrence or metastasis.

  7. Concurrent severe cardiovascular disease, including but not limited to:

    1. NYHA Class III-IV cardiac function;
    2. Severe arrhythmia, e.g., QTc ≥ 480 ms;
    3. Myocardial infarction or unstable angina within 6 months prior to screening;
    4. Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at rest on 2 or more consecutive measurements).

  8. Abnormal liver or kidney function, defined as:

    1. ALT > 2 × ULN or AST > 2 × ULN;
    2. SCr > 1.5 × ULN.
  9. History of or concurrent hypokalemia, or serum potassium below the lower limit of normal at screening.
  10. History of or current treatment for glaucoma or cataracts.
  11. Poorly controlled diabetes mellitus (fasting blood glucose > 10 mmol/L or HbA1c ≥ 8.0%).
  12. History of drug abuse, substance abuse, or alcoholism within 1 year prior to screening. Alcoholism defined as average daily alcohol consumption exceeding 2 units (1 unit = 360 mL beer, or 45 mL 40% liquor, or 150 mL wine).
  13. Current treatment with beta-blockers (including eye drops).
  14. Systemic corticosteroid use: within 4 weeks prior to screening or during screening/run-in requiring systemic corticosteroid therapy, or asthma requiring oral corticosteroid treatment.
  15. Use of biologic targeted therapies including anti-IgE monoclonal antibodies (e.g., omalizumab), anti-IL-5 monoclonal antibodies (e.g., mepolizumab), anti-IL-5 receptor monoclonal antibodies (e.g., benralizumab), or anti-IL-4 receptor monoclonal antibodies (e.g., dupilumab), currently within 5 half-lives of the drug.
  16. Oral examination revealing suspected candidiasis (unless definitively excluded by the investigator).
  17. Participation in another clinical trial and receipt of investigational drug within 2 months prior to enrollment.
  18. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test.
  19. Concurrent severe underlying diseases that may affect the evaluation of study efficacy or safety, or any condition that, in the investigator's judgment, makes the subject unsuitable for enrollment.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
338 participants (actual)

Study arms

  • Experimental
    Budesonide/Formoterol (Test Product) + Placebo of Comparator

    Participants will receive one inhalation of the test product, Budesonide/Formoterol Powder for Inhalation (II) 160 μg/4.5 μg (2 inhalations), twice daily, followed by one inhalation of the placebo matching the comparator (Symbicort® Turbuhaler®), twice daily, for 6 weeks.

    Drug: Budesonide and Formoterol Fumarate · Drug: Placebo of Budesonide and Formoterol Fumarate

  • Active comparator
    Symbicort® Turbuhaler® (Active Comparator) + Placebo of Test Product

    Participants will receive one inhalation of the active comparator, Symbicort® Turbuhaler® (budesonide/formoterol 160 μg/4.5 μg, 2 inhalations), twice daily, followed by one inhalation of the placebo matching the test product, twice daily, for 6 weeks.

    Drug: Placebo of Budesonide and Formoterol Fumarate · Drug: Budesonide and Formoterol Fumarate

Interventions

  • DrugBudesonide and Formoterol Fumarate

    Budesonide/formoterol 160 μg/4.5 μg per inhalation, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.

  • DrugPlacebo of Budesonide and Formoterol Fumarate

    Placebo matching the test product, containing inactive excipients only, administered as 2 inhalations twice daily via the Pingchuan® dry powder inhaler.

  • DrugBudesonide and Formoterol Fumarate

    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.

  • DrugPlacebo of Budesonide and Formoterol Fumarate

    Placebo matching the active comparator (Symbicort® Turbuhaler®), containing inactive excipients only, administered as 2 inhalations twice daily via the Turbuhaler® dry powder inhaler.

05

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

06

Study locations

28 sites
  • Hefei First People's Hospital
    Hefei, Anhui 230061, China
  • Beijing Chao-Yang Hospital, Capital Medical University
    Beijing, Beijing Municipality 100020, China
  • China-Japan Friendship Hospital
    Beijing, Beijing Municipality 100029, China
  • Peking University People's Hospital
    Beijing, Beijing Municipality 100044, China
  • The Second Affiliated Hospital of Xiamen Medical College
    Xiamen, Fujian 361021, China
  • Gansu Provincial People's Hospital
    Lanzhou, Gansu 730000, China
  • Huizhou Central People's Hospital
    Huizhou, Guangdong 516001, China
  • Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)
    Qingyuan, Guangdong 511518, China
  • Zhanjiang Central People's Hospital
    Zhanjiang, Guangdong 524045, China
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, Guizhou 563003, China
  • Harrison International Peace Hospital
    Hengshui, Hebei 053000, China
  • Hebei PetroChina Central Hospital
    Langfang, Hebei 065000, China
  • Daqing People's Hospital
    Daqing, Heilongjiang 163316, China
  • Yellow River Sanmenxia Hospital
    Sanmenxia, Henan 472000, China
  • The First Affiliated Hospital of Xinxiang Medical University
    Xinxiang, Henan 453100, China
  • Yueyang Central Hospital
    Yueyang, Hunan 414000, China
  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology
    Baotou, Inner Mongolia 014010, China
  • Baotou Central Hospital
    Baotou, Inner Mongolia 014040, China
  • Affiliated Hospital of Inner Mongolia Medical University
    Hohhot, Inner Mongolia 010050, China
  • Northern Jiangsu People's Hospital
    Yangzhou, Jiangsu 225001, China
  • The First Affiliated Hospital of Gannan Medical University
    Ganzhou, Jiangxi 341000, China
  • Central Hospital Affiliated to Shenyang Medical College
    Shenyang, Liaoning 110024, China
  • Jinan Central Hospital
    Jinan, Shandong 250013, China
  • Jining First People's Hospital
    Jining, Shandong 272011, China
  • Shanghai Pulmonary Hospital
    Shanghai, Shanghai Municipality 200433, China
  • Mianyang Central Hospital
    Mianyang, Sichuan 621000, China
  • Tianjin Fourth Central Hospital
    Tianjin, Tianjin Municipality 300140, China
  • Lishui Central Hospital
    Lishui, Zhejiang 323000, China
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared. The informed consent obtained from participants in this study did not include provisions for the sharing of individual participant data with third parties or for the transfer of data outside of China. Sharing IPD would therefore be inconsistent with the scope of the consent provided by participants and with applicable data protection requirements. Requests for the study protocol and statistical analysis plan may be directed to the sponsor at clinicalmedicine@chenpon.com and will be considered on a case-by-case basis.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07790159
Lead sponsor
Shanghai Xin Huanghe Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Aug 27, 2026
Start date
Feb 21, 2024
Primary completion
Sep 27, 2024
Completion
Nov 7, 2024
Last update
Aug 27, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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