Budesonide/Formoterol Inhalation Powder in Adults With Asthma

NCT07790159 | Completed Phase 3 DMC

• 2 other identifiers: SHXHH-BDF-CT-01CTR20234330
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 28

Brief 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

Conditions

Asthma

Keywords

Asthma; Budesonide, Formoterol Fumarate Drug Combination; Anti-Asthmatic Agents

Outcome Measures

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.

  Baseline (Day 1 pre-dose) to Day 43

Secondary Outcomes (10)

• FEV1 AUC0-12h on Day 1

  Day 1 (0 to 12 hours post-dose)

• Change from baseline in trough FEV1 at Day 15 and Day 29

  Baseline (Day 1 pre-dose) to Day 15, Day 29

• Change from baseline in FVC at Day 15, Day 29, and Day 43

  Baseline (Day 1 pre-dose) to Day 15, Day 29, Day 43

• Change from baseline in morning PEF

  Baseline (7-day run-in period) to weekly through Day 43

• Change from baseline in PEF diurnal variability at Day 43

  Baseline (7-day run-in period) to Day 43

Study Arms (2)

Budesonide/Formoterol (Test Product) + Placebo of Comparator

EXPERIMENTAL

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

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

ACTIVE COMPARATOR

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

Budesonide and Formoterol Fumarate DRUG

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

Budesonide/Formoterol (Test Product) + Placebo of Comparator

Placebo of Budesonide and Formoterol Fumarate DRUG

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

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Shanghai Xin Huanghe Pharmaceutical Co., Ltd.: lead

Study Sites (28)

Hefei First People's Hospital

Hefei, Anhui, 230061, China

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100020, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

The Second Affiliated Hospital of Xiamen Medical College

Xiamen, Fujian, 361021, China

Location

Gansu Provincial People's Hospital

Lanzhou, Gansu, 730000, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, 516001, China

Location

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

Qingyuan, Guangdong, 511518, China

Location

Zhanjiang Central People's Hospital

Zhanjiang, Guangdong, 524045, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

Location

Harrison International Peace Hospital

Hengshui, Hebei, 053000, China

Location

Hebei PetroChina Central Hospital

Langfang, Hebei, 065000, China

Location

Daqing People's Hospital

Daqing, Heilongjiang, 163316, China

Location

Yellow River Sanmenxia Hospital

Sanmenxia, Henan, 472000, China

Location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

Yueyang Central Hospital

Yueyang, Hunan, 414000, China

Location

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

Baotou, Inner Mongolia, 014010, China

Location

Baotou Central Hospital

Baotou, Inner Mongolia, 014040, China

Location

Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, 010050, China

Location

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

The First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, 341000, China

Location

Central Hospital Affiliated to Shenyang Medical College

Shenyang, Liaoning, 110024, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Jining First People's Hospital

Jining, Shandong, 272011, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Mianyang Central Hospital

Mianyang, Sichuan, 621000, China

Location

Tianjin Fourth Central Hospital

Tianjin, Tianjin Municipality, 300140, China

Location

Lishui Central Hospital

Lishui, Zhejiang, 323000, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: February 21, 2024
• Primary Completion: September 27, 2024
• Study Completion: November 7, 2024
• Last Updated: August 27, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (28)