Can a new inhaler match symbicort for asthma control?

NCT ID NCT07790159

Disease control Sponsor: Shanghai Xin Huanghe Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether a new budesonide/formoterol dry powder inhaler works as well as the established Symbicort Turbuhaler in adults with asthma. About 338 participants will take either the test inhaler or Symbicort twice daily for six weeks. Researchers will measure changes in lung function, symptom control, and safety to see if the new product is non-inferior to the standard treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Budesonide/formoterol inhalation powder
What this could lead to: If it works, this could offer a comparable, potentially more affordable alternative to Symbicort for controlling asthma symptoms.
What could go wrong: The trial is testing non-inferiority, not superiority, so the new inhaler may only match, not beat, the existing drug. Results depend on lung function measures over six weeks, and long-term safety remains unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

338 people

The number who actually took part.

Started

Feb 2024

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China
Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China
Baotou Central Hospital

Baotou, Inner Mongolia, 014040, China
Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China
Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, 110024, China
China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China
Daqing People's Hospital

Daqing, Heilongjiang, 163316, China
Gansu Provincial People's Hospital

Lanzhou, Gansu, 730000, China
Guangzhou Medical University Affiliated Qingyuan Hospital (Qingyuan People's Hospital)

Qingyuan, Guangdong, 511518, China
Harrison International Peace Hospital

Hengshui, Hebei, 053000, China
Hebei PetroChina Central Hospital

Langfang, Hebei, 065000, China
Hefei First People's Hospital

Hefei, Anhui, 230061, China
Huizhou Central People's Hospital

Huizhou, Guangdong, 516001, China
Jinan Central Hospital

Jinan, Shandong, 250013, China
Jining First People's Hospital

Jining, Shandong, 272011, China
Lishui Central Hospital

Lishui, Zhejiang, 323000, China
Mianyang Central Hospital

Mianyang, Sichuan, 621000, China
Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China
Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China
Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China
The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology

Baotou, Inner Mongolia, 014010, China
The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China
The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China
The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, 361021, China
Tianjin Fourth Central Hospital

Tianjin, Tianjin Municipality, 300140, China
Yellow River Sanmenxia Hospital

Sanmenxia, Henan, 472000, China
Yueyang Central Hospital

Yueyang, Hunan, 414000, China
Zhanjiang Central People's Hospital

Zhanjiang, Guangdong, 524045, China

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