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AsthmaPhase 3BF-ASTHMANCT07790159

Budesonide/Formoterol Inhalation Powder in Adults With Asthma

A Phase 3 study testing Budesonide and Formoterol Fumarate in people with Asthma, run by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. at 28 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
Budesonide and Formoterol Fumarate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
338 participants
Where
28 sitesChina
Study dates
21 Feb 2024to 7 Nov 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Aged 18 to 75 years (inclusive), male or female.
  • 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).
  • 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].
  • Positive result from any objective test for variable airflow limitation, either:
  • 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
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  • 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.
  • Pre-bronchodilator FEV1 between 45% and 85% of predicted normal value at screening.
  • 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.

Who cannot join

  • 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.
  • Hospitalization due to asthma within 2 months prior to screening.
  • 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.
  • Known hypersensitivity to any sympathomimetic drug (e.g., formoterol or salbutamol), any corticosteroid therapy, or lactose (excipient of the study drug).
  • 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.
  • 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.
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  • Concurrent severe cardiovascular disease, including but not limited to:
  • NYHA Class III-IV cardiac function;
  • Severe arrhythmia, e.g., QTc ≥ 480 ms;
  • Myocardial infarction or unstable angina within 6 months prior to screening;
  • Poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at rest on 2 or more consecutive measurements).
  • Abnormal liver or kidney function, defined as:
  • ALT > 2 × ULN or AST > 2 × ULN;
  • SCr > 1.5 × ULN.
  • History of or concurrent hypokalemia, or serum potassium below the lower limit of normal at screening.
  • History of or current treatment for glaucoma or cataracts.
  • Poorly controlled diabetes mellitus (fasting blood glucose > 10 mmol/L or HbA1c ≥ 8.0%).
  • 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).
  • Current treatment with beta-blockers (including eye drops).
  • Systemic corticosteroid use: within 4 weeks prior to screening or during screening/run-in requiring systemic corticosteroid therapy, or asthma requiring oral corticosteroid treatment.
  • 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.
  • Oral examination revealing suspected candidiasis (unless definitively excluded by the investigator).
  • Participation in another clinical trial and receipt of investigational drug within 2 months prior to enrollment.
  • Pregnant or lactating women, or women of childbearing potential with a positive pregnancy test.
  • 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.

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

China28 sites

  • The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

    Baotou, Inner Mongolia, 014010

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014040

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100020

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Daqing People's Hospital

    Daqing, Heilongjiang, 163316

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Hefei First People's Hospital

    Hefei, Anhui, 230061

  • Harrison International Peace Hospital

    Hengshui, Hebei, 053000

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010050

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516001

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Jining First People's Hospital

    Jining, Shandong, 272011

  • Hebei PetroChina Central Hospital

    Langfang, Hebei, 065000

  • Gansu Provincial People's Hospital

    Lanzhou, Gansu, 730000

  • Lishui Central Hospital

    Lishui, Zhejiang, 323000

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

  • Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)

    Qingyuan, Guangdong, 511518

  • Yellow River Sanmenxia Hospital

    Sanmenxia, Henan, 472000

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • Central Hospital Affiliated to Shenyang Medical College

    Shenyang, Liaoning, 110024

  • Tianjin Fourth Central Hospital

    Tianjin, Tianjin Municipality, 300140

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian, 361021

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan, 453100

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225001

  • Yueyang Central Hospital

    Yueyang, Hunan, 414000

  • Zhanjiang Central People's Hospital

    Zhanjiang, Guangdong, 524045

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563003

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Budesonide/Formoterol Inhalation Powder in Adults With Asthma

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:

Read more

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

Conditions
Asthma
Being tested
Budesonide and Formoterol Fumarate, Placebo of Budesonide and Formoterol Fumarate
Keywords
Asthma, Budesonide, Formoterol Fumarate Drug Combination, Anti-Asthmatic Agents
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide and Formoterol FumarateDrug

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

  • Placebo of Budesonide and Formoterol FumarateDrug

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

  • Budesonide and Formoterol FumarateDrug

    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 of Budesonide and Formoterol FumarateDrug

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

Study groups in NCT07790159
Study groupRoleWhat they receive
Budesonide/Formoterol (Test Product) + Placebo of ComparatorExperimentalParticipants 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.
Receives: Drug: Budesonide and Formoterol Fumarate; Drug: Placebo of Budesonide and Formoterol Fumarate
Symbicort® Turbuhaler® (Active Comparator) + Placebo of Test ProductActive comparatorParticipants 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.
Receives: Drug: Placebo of Budesonide and Formoterol Fumarate; Drug: Budesonide and Formoterol Fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline (Day 1 pre-dose) to Day 43

Secondary outcomes (10)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Day 1 through Day 43

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2026
  2. Study start21 Feb 2024
  3. Primary completion27 Sep 2024
  4. Study completion7 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07790159
Sponsor's protocol ID
SHXHH-BDF-CT-01
Other IDs
CTR20234330
Acronym
BF-ASTHMA
Status last verified
Jul 2025
First submitted
24 Aug 2026
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Budesonide and Formoterol Fumarate in people with Asthma, run by Shanghai Xin Huanghe Pharmaceutical Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in trough FEV1 after 42 days of treatment (time frame: Baseline (Day 1 pre-dose) to Day 43). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07790159.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.

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