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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for bronchial asthma, which combines a medication called Budesonide Formoterol with immune modulators (tablets containing Staphylococcus and Neisseria). The goal is to see if this combination can improve asthma control in patients who have not been able to manage their symptoms well with standard treatments. The trial is in the third phase, meaning it is being tested on a larger group of people to evaluate its effectiveness and safety before it can be approved for general use.

To participate in this study, individuals need to be at least 14 years old and have been diagnosed with asthma for at least six months. They should also have asthma that isn’t well controlled, according to certain guidelines. Participants will need to sign a consent form to show they understand the study and agree to take part. Those who have other serious health conditions, are pregnant or breastfeeding, or have allergies to the study medications won’t be eligible. If selected, participants can expect to receive either the study medication or a placebo (a non-active pill) and will be monitored closely throughout the trial to see how well the treatment works.

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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.