BronchiectasisNCT05407792
Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis
A study testing Staphylococcus and Neisseria Tablets and On-demand treatment in people with Bronchiectasis, run by Qianfoshan Hospital at 1 site in China.
Trial summary
The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Staphylococcus and Neisseria Tablets and On-demand treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bronchiectasis diagnosed by clinical manifestations and chest HRCT according to the diagnostic criteria for bronchiectasis;
- Patients with idiopathic or post-infectious bronchiectasis;
- 18years old;
- Patients should have at least 2 acute exacerbations within 1 year before enrollment;
- Patients in either acute exacerbation or stable period can be included.
Who cannot join
- Cystic fibrosis;
- Immunodeficiency, allergic bronchopulmonary aspergillosis, etc.;
- Traction bronchiectasis caused by severe emphysema or advanced pulmonary fibrosis;
- Still smoking;
- Complicated with asthma or chronic obstructive disease Lung;
- Patients with severe cardiovascular disease, severe neurological disease, or severe liver or kidney damage;
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- Malignant tumors;
- Allergy to Staphylococcus albicans tablets;
- Patients with a history of gastric ulcer or intestinal malabsorption;
- Pregnant or lactating women;
- patients with poor compliance;
- previous (within 6 months before the start of the study) or concurrently taking immunostimulating drugs (including thymosin, interferon, transfer factor, BCG, pneumonia vaccine and any kind of bacteria Extracts, such as Biostim, except for influenza vaccine) or immunosuppressants;
- Patients who are participating in or have participated in interventional clinical trials within 3 months.
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, 1 recruiting
- Recruiting
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, 250014
Qian Qi, Doctor, +86 13706380314, qiqianqlh@163.com
About this study
Official title: Efficacy and Safety of Long-term Oral Administration of Staphylococcus Albicans Tablets in Patients With Acute Exacerbation and Stable Bronchiectasis: a Multicenter, Prospective Randomized Controlled Clinical Trial
The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Secondary objective is to explore whether long-term oral administration of Staphylococcus albicans tablets can reduce the risk of hospitalization in patients with bronchiectasis and whether it can improve the quality of life of patients. Other purpose is to explore the regulatory effect of long-term oral administration of Staphylococcus albicans tablets on the immune function of patients with bronchiectasis.
Read the detailed description
Bronchiectasis is a chronic airway purulent disease. The four factors of "vicious circle" play an important role in the occurrence, development and prognosis of bronchiectasis. Attempts to breaks the vicious circle may be beneficial to reduce the acute exacerbation of bronchiectasis. The main ingredients of Staphylococcus albicans tablets are the inactivated cells of Staphylococcus albus, Catarella catarrhalis and Bacillus subtilis. It may be beneficial to improve the non-specific immunity of patients and the specific immune function of respiratory mucosa, and reduce airway mucus secretion and secretion retention. There is not yet sufficient clinical evidence to support the immune function regulation and related efficacy of patients. Therefore, the efficacy of long-term oral administration of Staphylococcus albicans tablets in patients with bronchiectasis needs to be further confirmed by clinical studies.
- Conditions
- Bronchiectasis
- Being tested
- Staphylococcus and Neisseria Tablets, On-demand treatment
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staphylococcus and Neisseria TabletsDrug
Also called H37023540
0.3 mg/ tablet, 4 tablets each time, 3 times a day (Shandong Qilu Pharmaceutical Co., LTD.), the course of treatment was more than 3 months.
On-demand treatmentOther
At the time of enrollment, patients with acute exacerbation of bronchiectasis were given routine treatment. For patients with stable bronchiectasis at the time of enrollment, they are treated as needed (that is, according to the needs of the disease, receive corresponding treatment).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Oral staphylococcus albicans tablet group. Receives: Drug: Staphylococcus and Neisseria Tablets |
| Control group | Other | On-demand treatment group Receives: Other: On-demand treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of acute exacerbations
Measured: Up to 12 months
Time to first exacerbation
Measured: Up to 12 months
Rate of readmission at 12 months
Measured: Up to 12 months
Number of acute exacerbations
Measured: up to 6 months
Number of acute exacerbations
Measured: Up to 3 months
Secondary outcomes (9)
Change from Baseline Life Quality Score at 12 months
Measured: Up to 12 months
Change from Baseline FEV1 at 12 months
Measured: Up to 12 months
Change from Baseline FEV1/FVC at 12 months
Measured: Up to 12 months
Change from Baseline FEV1 % predicted at 12 months
Measured: Up to 12 months
Change from Baseline sputum volume at 12 months
Measured: Up to 12 months
Change from Baseline percentage of patients with yellow purulent sputum at 12 months
Measured: Up to 12 months
Change from Baseline percentage of patients with immune dysfunction at 12 months
Measured: Up to 12 months
Change from Baseline of percentage of patients with positive sputum culture
Measured: Up to 12 months
Number of Participants with adverse reactions
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start6 Jun 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407792
- Sponsor's protocol ID
- 2022-5-26-QFS
- Status last verified
- Feb 2025
- First submitted
- 26 May 2022
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Long-term Oral Administration of Staphylococcus Albicans Tablets in Patients With Acute Exacerbation and Stable Bronchiectasis: a Multicenter, Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05407792
- Acronym / sponsor ID
- 2022-5-26-QFS
- Conditions
- Bronchiectasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 7 Jun 2022 (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.
The main purpose of this study is to investigate whether long-term oral administration of Staphylococcus albicans tablets can significantly reduce the number of acute exacerbations in patients with bronchiectasis. Secondary objective is to explore whether long-term oral administration of Staphylococcus albicans tablets can reduce the risk of hospitalization in patients with bronchiectasis and whether it can improve the quality of life of patients. Other purpose is to explore the regulatory effect of long-term oral administration of Staphylococcus albicans tablets on the immune function of patients with bronchiectasis.
Detailed description
Bronchiectasis is a chronic airway purulent disease. The four factors of "vicious circle" play an important role in the occurrence, development and prognosis of bronchiectasis. Attempts to breaks the vicious circle may be beneficial to reduce the acute exacerbation of bronchiectasis. The main ingredients of Staphylococcus albicans tablets are the inactivated cells of Staphylococcus albus, Catarella catarrhalis and Bacillus subtilis. It may be beneficial to improve the non-specific immunity of patients and the specific immune function of respiratory mucosa, and reduce airway mucus secretion and secretion retention. There is not yet sufficient clinical evidence to support the immune function regulation and related efficacy of patients. Therefore, the efficacy of long-term oral administration of Staphylococcus albicans tablets in patients with bronchiectasis needs to be further confirmed by clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Staphylococcus and Neisseria TabletsOral staphylococcus albicans tablet group. |
| Control group | Other | Other: On-demand treatmentOn-demand treatment group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with bronchiectasis diagnosed by clinical manifestations and chest HRCT according to the diagnostic criteria for bronchiectasis;
Key exclusion criteria (13 listed)
- Cystic fibrosis;
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 |
|---|---|---|
| Staphylococcus and Neisseria TabletsAlso: H370235400.3 mg/ tablet, 4 tablets each time, 3 times a day (Shandong Qilu Pharmaceutical Co., LTD.), the course of treatment was more than 3 months. | Drug | Experimental group |
| On-demand treatmentAt the time of enrollment, patients with acute exacerbation of bronchiectasis were given routine treatment. For patients with stable bronchiectasis at the time of enrollment, they are treated as needed (that is, according to the needs of the disease, receive corresponding treatment). | Other | Control group |
Primary outcome
Number of acute exacerbations
Time frame: Up to 12 months
Time to first exacerbation
Time frame: Up to 12 months
Rate of readmission at 12 months
Time frame: Up to 12 months
Number of acute exacerbations
Time frame: up to 6 months
Number of acute exacerbations
Time frame: Up to 3 months
9 secondary outcomes
Change from Baseline Life Quality Score at 12 months
Time frame: Up to 12 months
Change from Baseline FEV1 at 12 months
Time frame: Up to 12 months
Change from Baseline FEV1/FVC at 12 months
Time frame: Up to 12 months
Change from Baseline FEV1 % predicted at 12 months
Time frame: Up to 12 months
Change from Baseline sputum volume at 12 months
Time frame: Up to 12 months
Change from Baseline percentage of patients with yellow purulent sputum at 12 months
Time frame: Up to 12 months
Change from Baseline percentage of patients with immune dysfunction at 12 months
Time frame: Up to 12 months
Change from Baseline of percentage of patients with positive sputum culture
Time frame: Up to 12 months
Number of Participants with adverse reactions
Time frame: Up to 12 months
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 28 Feb 2025.
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Bronchiectasis
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.
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University
Jinan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staphylococcus and Neisseria Tablets and On-demand treatment in people with Bronchiectasis, run by Qianfoshan Hospital 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 5 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 28 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of acute exacerbations (time frame: Up to 12 months). The study lists 5 primary outcomes in all. 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 28 Feb 2025.