Efficacy and Safety of Long-term Oral Staphylococcus Albicans Tablets in Patients With Bronchiectasis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorQianfoshan Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Cystic fibrosis;

Immunodeficiency, allergic bronchopulmonary aspergillosis, etc.;

Traction bronchiectasis caused by severe emphysema or advanced pulmonary fibrosis;

Still smoking;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Staphylococcus and Neisseria Tablets

    Drug

    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 treatment

    Other intervention

    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).

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Number of acute exacerbations

Time frame
Up to 12 months
2

Time to first exacerbation

Time frame
Up to 12 months
3

Rate of readmission at 12 months

Time frame
Up to 12 months
4

Number of acute exacerbations

Time frame
up to 6 months

Secondary outcomes

1

Change from Baseline Life Quality Score at 12 months

Time frame
Up to 12 months
2

Change from Baseline FEV1 at 12 months

Time frame
Up to 12 months
3

Change from Baseline FEV1/FVC at 12 months

Time frame
Up to 12 months
4

Change from Baseline FEV1 % predicted at 12 months

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

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