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

NCT06895460 | Not Yet Recruiting Phase 3

• 1 other identifier: QL-BA-QIP-1001
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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)

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The overall asthma control rate at 24 weeks of treatment

  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

  Month 1, Month 2, Month 3, Month 4, Month 5, Month 6

• Changes in lung function indicators compared to baseline

  Month 3, Month 6

• Five-point Asthma Quality of Life Scoring

  Month 3, Month 6

Study Arms (2)

Budesonide Formoterol combined with placebo

PLACEBO COMPARATOR

Drug: Budesonide Formoterol; Drug: Placebo

Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)

EXPERIMENTAL

Drug: Budesonide Formoterol; Drug: Immune Modulators (Staphylococcus and Neisseria Tablets)

Interventions

Budesonide Formoterol DRUG

Investigator Selection

Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets); Budesonide Formoterol combined with placebo

Placebo DRUG

Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

Budesonide Formoterol combined with placebo

Immune Modulators (Staphylococcus and Neisseria Tablets) DRUG

Staphylococcus and Neisseria Tablets: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months

Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 14 years, male or female;
• Confirmed diagnosis of asthma at least 6 months prior to screening;
• Patients with uncontrolled asthma (according to the 2024 GINA guidelines-asthma control level classification criteria, patients with partially controlled and uncontrolled asthma);
• 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%;
• Before the first administration of the study drug, the patient has good function of major organs and no contraindications to ICS + LABA treatment;
• 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.

You may not qualify if:

• Patients with a history of severe asthma (according to the definition in the Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition));
• Patients in the acute exacerbation phase who may require intravenous/oral corticosteroids;
• Patients with rheumatology and immunology conditions;
• Atypical asthma or comorbidities such as pulmonary tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, pulmonary embolism, severe respiratory failure, or other respiratory system diseases;
• 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;
• Individuals allergic to the study drug or corticosteroids;
• Participation in another clinical trial within 30 days prior to screening or currently ongoing;
• 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;
• Women who are currently pregnant or breastfeeding, or women of childbearing potential who cannot use contraception during the study period;
• The participant is deemed unsuitable for study observation by the investigator.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; Adjuvants, Immunologic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Immunologic Factors; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Xin Yao, Chief physician

CONTACT

+8618651608881; xyao1998@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 26, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)