Clinical trial NCT06895460: A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)
Official title: 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 type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Bronchial Asthma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 198
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The overall asthma control rate at 12 weeks of treatment
timeFrame: week 12
Secondary outcomes:
measure: The overall asthma control rate at 24 weeks of treatment
timeFrame: week 24
measure: Number of acute asthma exacerbations
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Changes in Asthma Control Test (ACT) scores
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
measure: Changes in lung function indicators compared to baseline
timeFrame: Month 3, Month 6
measure: Five-point Asthma Quality of Life Scoring
timeFrame: Month 3, Month 6
measure: Adverse events (AEs)
timeFrame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu
state: Jiangsu
Study officials:
References: