Bronchial AsthmaPhase 3NCT06895460
A Trial on the Treatment of Bronchial Asthma With Budesonide Formoterol Combined With Immune Modulators (Staphylococcus and Neisseria Tablets)
A Phase 3 study testing Budesonide Formoterol and Immune Modulators (Staphylococcus and Neisseria Tablets) in people with Bronchial Asthma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Budesonide Formoterol and Immune Modulators (Staphylococcus and Neisseria Tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital with Nanjing Medical University, Nanjing, Jiangsu
Nanjing, Jiangsu, 210000
Xin Yao Chief physician, 18651608881, xyao1998@126.com
About this study
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)
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)
Read the 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.
- Conditions
- Bronchial Asthma
- Being tested
- Budesonide Formoterol, Placebo, Immune Modulators (Staphylococcus and Neisseria Tablets)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide FormoterolDrug
Investigator Selection
PlaceboDrug
Placebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months
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
| Study group | Role | What they receive |
|---|---|---|
| Budesonide Formoterol combined with placebo | Placebo comparator | Not described Receives: Drug: Budesonide Formoterol; Drug: Placebo |
| Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets) | Experimental | Not described Receives: Drug: Budesonide Formoterol; Drug: Immune Modulators (Staphylococcus and Neisseria Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: week 12
Secondary outcomes (6)
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%
Measured: week 24
Number of acute asthma exacerbations
Measured: 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.
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Changes in lung function indicators compared to baseline
Changes in PEF
Measured: 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.
Measured: Month 3, Month 6
Adverse events (AEs)
Measured: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start20 Jun 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06895460
- Sponsor's protocol ID
- QL-BA-QIP-1001
- Status last verified
- Jun 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06895460
- Acronym / sponsor ID
- QL-BA-QIP-1001
- Conditions
- Bronchial Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Before the first administration of the study drug, the patient has good function of major organs and no contraindications to ICS + LABA treatment;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide FormoterolInvestigator Selection | Drug | Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets), Budesonide Formoterol combined with placebo |
| PlaceboPlacebo: 0.3 mg/tablet, 4 tablets per dose, 3 times per day, for a course of 3 months | Drug | Budesonide Formoterol combined with placebo |
| 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 | Drug | Budesonide Formoterol Combined with Immune Modulators (Staphylococcus and Neisseria Tablets) |
Primary outcome
The overall asthma control rate at 12 weeks of treatment
Time frame: week 12
The overall control rate = (number of well-controlled cases + number of partially controlled cases) / total number of cases × 100%
6 secondary outcomes
The overall asthma control rate at 24 weeks of treatment
Time frame: week 24
Number of acute asthma exacerbations
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Changes in Asthma Control Test (ACT) scores
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Changes in lung function indicators compared to baseline
Time frame: Month 3, Month 6
Five-point Asthma Quality of Life Scoring
Time frame: Month 3, Month 6
Adverse events (AEs)
Time frame: Month 1, Month 2, Month 3, Month 4, Month 5, Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide Formoterol and Immune Modulators (Staphylococcus and Neisseria Tablets) in people with Bronchial Asthma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Yao, Chief physician (+8618651608881, xyao1998@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall asthma control rate at 12 weeks of treatment (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.