A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial on the Treatment of Bronchial Asthma with Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchial Asthma
• Intervention / Treatment: Drug: Budesonide Formoterol; Drug: Placebo; Drug: Immune Modulators (Staphylococcus and Neisseria Tablets)

Detailed Description

This study is a randomized, double-blind, placebo-controlled, multicenter clinical trial. A total of 198 participants with bronchial asthma are planned to be enrolled and randomized in a 1:1 ratio to the experimental group and the control group. The experimental group will receive Budesonide Formoterol Powder for Inhalation plus immune modulators (Staphylococcus and Neisseria Tablets), while the control group will receive Budesonide Formoterol Powder for Inhalation plus placebo. The treatment period is 3 months for both groups, followed by a 3-month follow-up after treatment.

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xin Yao, Chief physician; Phone Number: +8618651608881; Email: xyao1998@126.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu
      • Contact: Xin Yao Chief physician; Phone Number: 18651608881; Email: xyao1998@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 14 years, male or female;
2. Confirmed diagnosis of asthma at least 6 months prior to screening;
3. Patients with uncontrolled asthma (according to the 2024 GINA guidelines-asthma control level classification criteria, patients with partially controlled and uncontrolled asthma);

4. Within the past 6 months, at least one of the following positive test results for lung function:

   • Positive bronchodilator test with an increase in FEV1 of ≥12%, and an absolute increase in FEV1 of ≥200 ml;
   • Positive bronchial provocation test or exercise challenge test;
   • Peak expiratory flow (PEF) variability over 2 weeks with a daily variation rate of ≥20% or a weekly average variation rate of ≥10%;
   • Significant improvement in lung function after 4 weeks of asthma treatment, with an increase in FEV1 of ≥12%, an absolute increase in FEV1 of ≥200 ml, or an improvement in PEF of ≥20%;
5. Before the first administration of the study drug, the patient has good function of major organs and no contraindications to ICS + LABA treatment;
6. The participant (or their legal representative) must sign and date the informed consent form, indicating their understanding of the study's purpose and the procedures involved, and their willingness to participate in the study.

Exclusion Criteria:

1. Patients with a history of severe asthma (according to the definition in the Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition));
2. Patients in the acute exacerbation phase who may require intravenous/oral corticosteroids;
3. Patients with rheumatology and immunology conditions;
4. Atypical asthma or comorbidities such as pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, pulmonary embolism, severe respiratory failure, or other respiratory system diseases;
5. Individuals with significant diseases other than bronchial asthma. Significant diseases are defined as conditions that, in the investigator's judgment, may place the participant at risk or affect the study results, such as severe cardiovascular, cerebrovascular, hepatic, renal, hematologic diseases, malignancies, psychiatric disorders, immune system diseases, or pulmonary organic functional impairments;
6. Individuals allergic to the study drug or corticosteroids;
7. Participation in another clinical trial within 30 days prior to screening or currently ongoing;
8. Use of immune modulators (including thymosin, thymopeptides, interferon, transfer factor, Bacillus Calmette-Guérin polysaccharides, any type of bacterial extracts, such as Biostim, bacterial lysate capsules) within 30 days prior to the use of the study drug or during the study period;
9. Women who are currently pregnant or breastfeeding, or women of childbearing potential who cannot use contraception during the study period;
10. The participant is deemed unsuitable for study observation by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Budesonide Formoterol combined with placebo	Drug: Budesonide Formoterol; Investigator Selection; Drug: Placebo; Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months
Experimental: Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)	Drug: Budesonide Formoterol; Investigator Selection; Drug: Immune Modulators (Staphylococcus and Neisseria Tablets); Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall asthma control rate at 12 weeks of treatment	The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%	week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The overall asthma control rate at 24 weeks of treatment	The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%	week 24
Number of acute asthma exacerbations		Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Changes in Asthma Control Test (ACT) scores	The minimum and maximum scores of the Asthma Control Test are 5 and 25 points respectively. The higher the ACT score, the better the asthma control.	Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Changes in lung function indicators compared to baseline	Changes in PEF	Month 3, Month 6
Five-point Asthma Quality of Life Scoring	The minimum and maximum total scores of the 5-point asthma quality of life assessment are 35 and 175 points respectively. The higher the score, the better the patient's quality of life.	Month 3, Month 6
Adverse events (AEs)		Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: February 27, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Asthma; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Formoterol Fumarate; Immunomodulating Agents; Budesonide
• Other Study ID Numbers: QL-BA-QIP-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No